Trials[JOURNAL]
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200 papers
Evaluation of a disability-inclusive ultra-poor graduation programme in Bangladesh: study protocol for a cluster-randomised controlled trial.
Carew MT, Rahman S, Banks LM … +4 more , Gomes M, Kamruzzaman M, Das N, Kuper H
Trials · 2026 May · PMID 42177537 · Full text
BACKGROUND: There remains a lack of evidence on which livelihoods interventions are effective for persons with disabilities, particularly given the fact that the impact of interventions varies according to contextual fac...
BACKGROUND: There remains a lack of evidence on which livelihoods interventions are effective for persons with disabilities, particularly given the fact that the impact of interventions varies according to contextual factors. The disability-inclusive ultra-poor graduation (DIUPG) programme is an adaptation of the ultra-poor graduation programme (UPG), designed to tackle extreme poverty among persons with disabilities. The DIUPG programme has been previously evaluated in Uganda and found to have successfully improved household consumption, amidst the challenges of COVID-19 and funding cuts. The current evaluation of DIUPG programme therefore creates the opportunity to generate comparative data on the programme in a different context (Bangladesh), which will aid understanding of the transferability and robustness of the intervention. METHODS: The DIUPG provides standard UPG support such as asset transfers, combined with disability-specific elements such as rehabilitation and psychosocial therapy. The evaluation will adopt a cluster-randomised superiority trial design with two parallel groups, with clusters comprising branch office catchment areas of the intervention implementer. The units of participation in DIUPG are households living in these geographical areas. Household eligibility is determined through household screening utilising standardised measures to identify ultra-poor households that have members with disabilities. Clusters are randomly selected prior to DIUPG implementation, resulting in 48 intervention and 24 control clusters. The primary outcomes of the evaluation are per capita household income, income and employment of persons with disabilities, per capita food consumption and expenditures, and per capita non-food expenditures. Prior to intervention implementation, baseline data is collected in the treatment and control arms (May-June 2023). After DIUPG conclusion (20 months), endline data are collected (October-November 2025) in both arms. DISCUSSION: There is a general paucity of evidence regarding what interventions work to create better livelihoods for persons with disabilities and their families. Evaluating the DIUPG programme in Bangladesh will generate crucial evidence demonstrating whether similar benefits of the programme as observed in Uganda accrue in a distinct context. TRIAL REGISTRATION: ISRCTN registry ISRCTN10602983. Retrospectively registered on 05/05/2025.
Effect of balance training exercises with stroboscopic glasses on postural control, gait, and physical performance in the elderly population: study protocol for a randomized controlled trial.
Javid Jahromi N, Hessam M, Saadat M … +1 more , Mehravar M
Trials · 2026 May · PMID 42174703 · Full text
BACKGROUND: Aging is the process that declines all the sensory elements that are involved in postural control-"particularly vestibular and proprioceptive"-and these changes are generally compensated with reliance on visu...
BACKGROUND: Aging is the process that declines all the sensory elements that are involved in postural control-"particularly vestibular and proprioceptive"-and these changes are generally compensated with reliance on visual inputs for postural control in this population. Stroboscopic glasses can intermittently disrupt the visual feedback to possibly stimulate sensory reweighting toward the vestibular and proprioceptive inputs. In this study, the impact of balance training with stroboscopic glasses against balance training with non-stroboscopic sunglasses on postural control, gait, and physical function among the elderly is evaluated. METHODS: A total of fifty participants aged 60 years and above will be assigned randomly to either intervention (with stroboscopic glasses that intermittently block visual information) or control (the same exercises with regular sunglasses) groups. Primary outcomes postural control (force plate assessments under eyes-open and eyes-closed condition in feet-together and tandem stance), gait (10-Meter Walk Test), and physical function (Timed Up and Go, Five Times Sit-to-Stand, Functional Reach, and Push and Release Tests) will be measured at baseline, post-intervention, and 4-week follow-up. Exercises based on the Otago Exercise Program will take three sessions per week for 4 weeks, with the last session used as an attendance record session. DISCUSSION: Positive outcomes from this study will support the practice of older adult balance training under stroboscopic glasses. We hypothesized greater improvements in all outcome measures for the stroboscopic balance exercise group compared to the control group. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT20201112049361N2), registered 2025-02-21, https://irct.behdasht.gov.ir/user/trial/80977/view.
After-School to Pre-Sleep Energy Restriction for obesity in primary school children in grades 3-6: protocol for a parallel, randomized controlled trial.
Xie X, Lv Y, Li X … +6 more , He Y, Li L, Xuan X, Liu X, Yang H, Liang X
Trials · 2026 May · PMID 42174681 · Full text
BACKGROUND: The rising prevalence of childhood obesity has become a major global public health concern. Dietary intervention remains the cornerstone of pediatric obesity management. However, both conventional all-day ene...
BACKGROUND: The rising prevalence of childhood obesity has become a major global public health concern. Dietary intervention remains the cornerstone of pediatric obesity management. However, both conventional all-day energy-restricted diets and time-restricted eating have limitations in school-aged children. Studies indicate that excessive evening caloric intake is closely associated with obesity. This trial aims to evaluate the efficacy of an After-School to Pre-Sleep Energy Restriction (ASER) strategy compared with standard dietary intervention for pediatric obesity management. METHODS AND ANALYSIS: This study is a prospective, randomized, open-label, parallel-group trial. We plan to enroll 164 obese children from grades 3 to 6, who will be stratified by age, gender, and BMI z-score and randomly assigned in a 1:1 ratio to either the ASER group or the control group. The 24-week intervention consists of an intensive phase (weeks 0-12) followed by a maintenance phase (weeks 13-24). The primary endpoint is the between-group difference in BMI z-score (BMIz) change at week 12. Secondary endpoints include within-group BMIz changes at week 12; between-group and within-group BMIz changes at week 24; between-group and within-group changes in %BMI, body composition, growth parameters, cardiometabolic markers, and psychobehavioral metrics at both 12 and 24 weeks; and between-group differences in the incidence of adverse events at weeks 12 and 24. ETHICS AND DISSEMINATION: This study was approved by the Medical Ethics Committee of the First Affiliated Hospital of Guangxi Medical University (Approval No.: 2025-K0254). Written informed consent will be obtained from legal guardians, and assent will be obtained from child participants prior to enrollment. Study findings will be published in peer-reviewed journals. TRIAL REGISTRATION: The trial was prospectively registered on 3 September 2025, prior to the first participant enrollment, with the Chinese Clinical Trial Registry (ChiCTR2500108702). The URL of the specific trial registry record is https://www.chictr.org.cn/showproj.html?proj=275435.
Design, implementation, and evaluation of a mobile-based self-care application to enhance self-care behaviors in patients with rheumatoid arthritis in Iran: a mixed-methods study protocol with an interventional design.
Banafshi Z, Nayeri ND, Rezaeian S … +3 more , Mansoory MS, Moghimi N, Khatony A
Trials · 2026 May · PMID 42169185 · Full text
BACKGROUND: Rheumatoid arthritis (RA) is a chronic autoimmune disease that requires long-term management and active self-care. In this context, emerging technologies-particularly mobile health applications-have demonstra...
BACKGROUND: Rheumatoid arthritis (RA) is a chronic autoimmune disease that requires long-term management and active self-care. In this context, emerging technologies-particularly mobile health applications-have demonstrated considerable potential in facilitating and enhancing self-care among patients with RA. This study aims to design, implement, and evaluate the effectiveness of a mobile-based self-care application to improve self-management in individuals with RA. METHODS: This study employs a sequential exploratory mixed-methods design with three phases, conducted in Sanandaj, Kurdistan Province, West Iran. In the qualitative phase (4 months), a conventional content analysis approach will be used to explore self-care experiences, needs, barriers, and facilitators among patients with RA. Data will be collected through semi-structured interviews using purposive maximum-variation sampling until saturation is reached. The data will be analyzed using the Graneheim and Lundman method to extract categories. In the development phase (8 months), the Nominal Group Technique (NGT) will be conducted with a multidisciplinary expert panel to refine, enrich, and prioritize the identified needs and define the mobile application's content. Software development will follow the Waterfall Model. Usability and user satisfaction will be evaluated through expert reviews and a pilot study involving 30 patients. In the quantitative phase (4 months), a Randomized Controlled Trial (RCT) will assess the application's effectiveness. Seventy-two RA patients will be randomly assigned to intervention (n = 36) or control (n = 36) groups. Both groups will receive routine care, while the intervention group will additionally use the application for 8 weeks. Outcomes include self-care levels, quality of life, and disability index. Ethical and administrative approvals were obtained prior to study commencement. DISCUSSION: This study investigates the impact of a mobile-based self-care application on improving self-care behaviors and disease management among patients with RA. The design and implementation of this application are expected to enhance patient experiences, promote self-care, and reduce negative disease outcomes, while also improving quality of life and lowering the disability index. TRIAL REGISTRATION: IRCT, IRCT20100913004736N30. Registered on 2 October 2025 and approved by the Ethics Committee of Kermanshah University of Medical Sciences ((IR.KUMS.REC.1403.603)). Available at: https://irct.behdasht.gov.ir/search/result?query=IRCT20100913004736N29.
Is telerehabilitation inferior to face-to-face rehabilitation at improving adherence and pain in patients with chronic low back pain? Protocol for a non-inferiority randomized clinical trial with economic evaluation.
Broisler CN, Saragiotto BT, Miyamoto GC … +4 more , Gaban GLNA, da Silva VR, Siqueira JLD, Selistre LFA
Trials · 2026 May · PMID 42169146 · Full text
BACKGROUND: Exercise is a key component in reducing pain and disability in patients with chronic low back pain (CLBP). Barriers such as geographic distance, treatment costs, lack of support, and low self-efficacy can lim...
BACKGROUND: Exercise is a key component in reducing pain and disability in patients with chronic low back pain (CLBP). Barriers such as geographic distance, treatment costs, lack of support, and low self-efficacy can limit access to physiotherapy and compromise adherence. Synchronous telerehabilitation (ST) has the potential to overcome these barriers, support self-management, and improve adherence to exercise. However, its clinical effectiveness and cost-effectiveness compared with face-to-face rehabilitation remain unclear. This study aims to investigate whether ST is non-inferior to face-to-face rehabilitation in improving adherence and reducing pain and its cost-effectiveness in patients with CLBP. METHODS: This non-inferiority randomized controlled trial (RCT), parallel, two-arm with economic evaluation, will be conducted in a middle-income country (Brazil). A total of 160 individuals with CLBP, aged between 18 and 65 years, will be recruited. Participants will be randomly allocated into two groups: ST or face-to-face rehabilitation. Both groups will receive seven individual 60-min physiotherapy sessions over 12 weeks, including pain education, exercise therapy, and self-management strategies. Primary outcomes will be adherence and pain intensity. Secondary outcomes will include function, global perception of change, satisfaction, self-efficacy, therapeutic alliance, healthcare attendance and health-related quality of life. Outcomes assessments will be conducted at baseline, post-intervention (3 month), and at 6- and 9-month follow-up after allocation. The economic evaluation will be conducted from a societal perspective with a 9-month time horizon. Cost-effectiveness and cost-utility analyses will be conducted for pain intensity and quality-adjusted life years, respectively. DISCUSSION: If ST is non-inferior to face-to-face rehabilitation, it could serve as a clinically viable, cost-effective alternative for managing CLBP, expanding access to care while maintaining treatment quality. The findings may guide physiotherapists, healthcare systems, and policymakers in integrating telehealth strategies into routine rehabilitation practice. TRIAL REGISTRATION: Brazilian Clinical Trials Registry ID: RBR-57pgmjr. Registered on November 13, 2025.
Cipepofol for adjunctive sedation during neuraxial anesthesia: a study protocol for a randomized controlled trial.
Chen M, Chen L, Yang Y … +3 more , Huang S, Ren Y, Wang L
Trials · 2026 May · PMID 42169054 · Full text
BACKGROUND: Cipepofol is a novel 2,6-disubstituted phenol derivative increasingly used for anesthesia and sedation during gastrointestinal endoscopy and fiberoptic bronchoscopy. This study aimed to evaluate the efficacy...
BACKGROUND: Cipepofol is a novel 2,6-disubstituted phenol derivative increasingly used for anesthesia and sedation during gastrointestinal endoscopy and fiberoptic bronchoscopy. This study aimed to evaluate the efficacy and safety of cipepofol for adjunctive sedation during neuraxial anesthesia, thereby providing evidence for its clinical application. METHODS: This was a randomized, double-blind, non-inferiority trial. Eligible patients were randomly assigned in a 1:1 ratio to either the cipepofol group or the propofol group using a random number table. The target sedation level was defined as a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score of 3-4. Patients allocated to the cipepofol group received an intravenous loading dose of 0.1 mg/kg cipepofol administered over 30 ± 10 s, followed by a continuous infusion initiated at 0.3 mg/kg/h to achieve the target sedation level. Those in the propofol group received an intravenous loading dose of 0.5 mg/kg propofol administered over 30 ± 10 s, followed by a continuous infusion initiated at 1.5 mg/kg/h. The primary outcome was the sedation success rate. Secondary outcomes included the following: the percentage of total study drug administration time during which MOAA/S scores were maintained at 3-4, 1-2, or 5, respectively; time from the start of the intravenous loading dose to the first occurrence of MOAA/S score < 4, and the proportion of subjects achieving MOAA/S score < 4 within 3 min; proportion of subjects requiring rescue sedation; the vital signs of subjects; number of dose adjustments and total sedative drug consumption; time from discontinuation of the study drug infusion to the first postoperative MOAA/S score of 5, length of stay in the post-anesthesia care unit (PACU), and recovery status at PACU discharge; satisfaction levels of the anesthesiologist, surgeon, and subjects. DISCUSSION: The purpose of this study is to evaluate the efficacy and safety of cipepofol as an adjunct sedative during neuraxial anesthesia. If cipepofol demonstrates beneficial properties comparable to propofol for adjunctive sedation during neuraxial anesthesia, it could serve as a viable clinical alternative. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2500102635. Registered on 16 May 2025, www.chictr.org.cn. Prospectively registered.
Metabolic health effects of the timing of lifestyle behaviours in a combined lifestyle intervention in adults who have obesity or are overweight with complications: protocol for a two-armed, cluster-randomized, pragmatic trial-a TIMED study.
Slebe R, de Mutsert R, Després JP … +6 more , Campbell DJT, Kalsbeek A, Schrauwen P, Beulens JWJ, Rutters F, on behalf of the TIMED consortium
Trials · 2026 May · PMID 42163404 · Full text
BACKGROUND: As done in combined lifestyle interventions (CLI), a combination of physical activity, diet, and sleep interventions is effective in reducing body mass index (BMI) and hyperglycaemia. The timing of the behavi...
BACKGROUND: As done in combined lifestyle interventions (CLI), a combination of physical activity, diet, and sleep interventions is effective in reducing body mass index (BMI) and hyperglycaemia. The timing of the behaviours during the day may also affect metabolic health, due to individuals' circadian rhythms, but the impact of this is not well known. Thus, the inclusion of education on the timing of lifestyle behaviours may be an important addition to CLIs. Therefore, we aim to investigate the metabolic health effect of adding education on timing of lifestyle behaviours to an online CLI among adults who have obesity or are overweight with complications, compared to standard CLI, and routine care. METHODS: In this two-armed, cluster-randomized, superiority, pragmatic trial, at least ten CLI counselling groups will be cluster-randomized to either the standard CLI or the TIMED CLI, with added education on the timing of sleep, physical activity, and dietary intake. Among these clusters, we aim to recruit approximately 100 participants. The primary outcome is self-reported BMI at baseline, and at 3, 9, and 24 months. Secondary outcomes are health-related quality of life (HRQoL) measured using a questionnaire, self-reported waist circumference, fasting glucose and HbA1c measured using at-home finger prick testing at baseline, and at 3, and 9 months. Adherence will be assessed through questionnaires and attendance to the CLI sessions. In addition, an observational control group of 800 participants from a routine care database will be included for comparison. Recruitment started in July 2024. DISCUSSION: To our knowledge, this is the first pragmatic, cluster-randomized trial that investigates the incorporation of education on circadian timing of lifestyle behaviours in a routine care CLI. The pragmatic design will enable the investigation of the feasibility and metabolic health effect of implementing these timed interventions in a routine care setting. TRIAL REGISTRATION: ISRCTN registry, protocol number ISRCTN14642827. Registered on 7 December 2023, www.isrctn.com/ISRCTN14642827.
Cognitive Groove community-based rehabilitation for older adults: study protocol for a multisite parallel randomized controlled trial.
Papaioannou A, Ioannidis G, Kennedy C … +21 more , Hladysh G, Lee J, Adachi JD, Cowan D, Duarte D, Hategan A, Innes A, Keen S, Marr S, McArthur C, McKenna B, Tarride JÉ, Thabane L, Rabinovich A, Thrall S, Wang M, Azizudin AM, Choo WLO, Marr C, Perrotta A, Hewston P
Trials · 2026 May · PMID 42163402 · Full text
BACKGROUND: Promoting and maintaining intrinsic capacity, the composite of an individual's physical and mental abilities, is central to the World Health Organization's Integrated Care for Older People (ICOPE) framework....
BACKGROUND: Promoting and maintaining intrinsic capacity, the composite of an individual's physical and mental abilities, is central to the World Health Organization's Integrated Care for Older People (ICOPE) framework. Intrinsic capacity reflects a person's overall functional ability and resilience. Strengthening intrinsic capacity through community-based, person-centered interventions is key to enabling older adults to live independently and maintain well-being. Dance-based rehabilitation represents a promising, holistic approach that supports multiple domains of intrinsic capacity, including locomotor, cognitive, and psychological function, within a single, engaging program. METHODS: This two-arm, parallel-group, single-blind trial compares Cognitive Groove to wait-listed control. Participants will attend 1-h group classes twice weekly for 3 months at YMCA sites. Eligibility includes a FRAIL Scale score ≥ 2, ability to walk 25 m (with or without assistive devices), and follow two-step instructions. The target sample is 250 older adults (125 per arm). The primary outcome is physical performance, measured by the Short Physical Performance Battery (SPPB), representing locomotor capacity within the ICOPE framework. Secondary outcomes align with other ICOPE domains and include measures of cognitive, psychological, sensory, and vitality capacities. Outcomes will be analyzed using generalized linear model (GLM) analysis to assess between-group differences over time. This protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. DISCUSSION: By evaluating Cognitive Groove in real-world settings, the study will generate critical evidence to support the implementation of scalable, non-pharmacological strategies for frailty management in community-dwelling older adults. TRIAL REGISTRATION: This trial is registered on ClinicalTrials.gov (NCT06870149).
Trazodone, melatonin, and combination therapy for insomnia, fatigue, and daytime sleepiness following traumatic brain injury: study protocol for a randomized clinical trial.
Gharooee Ahangar S, Hasanpour M, Fatahian R … +2 more , Zarei P, Mehdizadeh H
Trials · 2026 May · PMID 42163386 · Full text
BACKGROUND: Sleep problems are common and disabling after traumatic brain injury (TBI). They negatively affect cognitive recovery, emotions, and overall quality of life. Fatigue and excessive daytime sleepiness are also...
BACKGROUND: Sleep problems are common and disabling after traumatic brain injury (TBI). They negatively affect cognitive recovery, emotions, and overall quality of life. Fatigue and excessive daytime sleepiness are also frequent and significantly impair daily functioning. Although trazodone and melatonin are used off-label, we still do not know which works better or if they are more effective together for improving sleep quality, fatigue, and daytime sleepiness in TBI patients. This randomized, double-blind clinical trial aims to compare the effectiveness of trazodone, melatonin, and their combination for improving sleep quality, fatigue severity, and daytime sleepiness in adults with moderate to severe TBI. METHODS: Forty-eight adults with moderate to severe TBI (Glascow Coma Scale (GCS) score of 3-12) and insomnia (insomnia severity index score (ISI) ≥ 8) will be randomly assigned (1:1:1) to receive nightly trazodone (25-100 mg), melatonin (3-5 mg), or both for 4 weeks. Changes in sleep quality (Insomnia Severity Index, ISI), fatigue severity (fatigue severity scale, FSS), and daytime sleepiness (Epworth sleepiness scale, ESS) will be assessed before and after treatment. Recruitment is ongoing. The data will be analyzed via mixed-design ANOVA, with suitable post hoc tests and nonparametric alternatives if the assumptions are not met. DISCUSSION: This study is one of the first to compare trazodone and melatonin alone and in combination for insomnia, fatigue, and daytime sleepiness in TBI patients. The results will help improve treatment strategies for managing sleep problems, fatigue, and daytime sleepiness in individuals with traumatic brain injury. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT) IRCT20241121063793N1. Registered on December 28, 2024.
OutProFeed-Italy: a cluster randomized controlled trial of routine outcome monitoring and feedback-informed psychotherapy for outpatients.
Compare A, La Tona A, Masella C … +8 more , Olive MV, Brugnera A, Ostwald V, Carcione A, Pievani L, Poletti B, Tasca GA, Coco GL
Trials · 2026 May · PMID 42163374 · Full text
BACKGROUND: Routine outcome monitoring (ROM) with timely feedback to therapists may improve psychotherapy outcomes. OutProFeed-Italy is a protocol for a three-arm cluster randomized controlled trial (RCT) using a Zelen d...
BACKGROUND: Routine outcome monitoring (ROM) with timely feedback to therapists may improve psychotherapy outcomes. OutProFeed-Italy is a protocol for a three-arm cluster randomized controlled trial (RCT) using a Zelen design to test whether feedback-informed therapy (FIT) delivered through a digital platform (Mindy) improves patient outcomes and therapeutic processes in routine outpatient psychotherapy in Italy. METHODS: The study will recruit psychotherapy trainees and licensed psychotherapists practicing in Italy (licensed psychotherapists or trainees in ≥3rd year of an Italian Ministry of University and Research-recognized psychotherapy program) and their adult outpatients (≥18 years, with fewer than three sessions with the participating therapist; excluding psychotic and neurocognitive disorders). Therapists will be recruited by the research team through universities and professional networks, and each therapist will recruit 2-5 eligible patients from routine outpatient practice. Therapists (clusters) will be randomized 1:1:1 by an independent statistician to three conditions: (1) outcome and process monitoring only (OPM), with session-by-session measures results of which are displayed to therapists but without feedback with clinical support tools (CST); (2) outcome and process monitoring plus feedback (OPM-F), in which therapists receive feedback through Mindy's clinical support tools based on FIT principles, together with monthly supervision for 3 months; and (3) treatment as usual (TAU), with no monitoring or feedback, and assessments only at baseline, session 15, and 3-month follow-up. The planned sample size is 182 therapists (61 per arm) and approximately 546 patients. The primary outcomes are symptom severity from baseline to session 15 and 3-month follow-up; secondary outcomes include psychological distress, therapeutic alliance, and dropout rates. Safety will be monitored through repeated symptom and risk assessments and the recording of adverse events and withdrawals, with referral procedures as needed. First enrollment started in November 2024. DISCUSSION: We hypothesize that, compared with OPM and TAU, patients treated by therapists in the OPM-F condition will show greater symptom improvement, fewer dropouts, and better therapeutic alliance trajectories. Findings may inform the implementation of ROM and FIT supported by digital platforms in Italian routine care. TRIAL REGISTRATION: ClinicalTrials.gov NCT06356961. Registered on April 10, 2024.
Efficacy of ultraviolet germicidal irradiation (UVGI) devices to decrease the incidence of respiratory infections in nursing homes: study protocol for a cluster randomized crossover trial (RESPROTECT).
Cornille C, Luneau E, Gabillard D … +13 more , Mathieu M, Lengagne S, Perrin E, Ezzouak M, Gondol F, Peuriere M, Maubert B, Saint-Sardos P, Peghaire S, Blanc FX, Ekouevi DK, Anglaret X, Gadea E
Trials · 2026 May · PMID 42163326 · Full text
BACKGROUND: Ultraviolet germicidal irradiation (UVGI) has long been recognized for its ability to inactivate airborne pathogens under experimental conditions. However, despite strong in vitro evidence, randomized clinica...
BACKGROUND: Ultraviolet germicidal irradiation (UVGI) has long been recognized for its ability to inactivate airborne pathogens under experimental conditions. However, despite strong in vitro evidence, randomized clinical evidence of its real-world effectiveness remains lacking. Nursing homes-where respiratory infections are a major cause of morbidity and mortality-represent a highly relevant setting to evaluate the preventive potential of UVGI. The RESPROTECT trial aims to assess whether continuous UVGI use in communal areas of nursing homes reduces the incidence of severe acute respiratory infections (ARIs) among residents. METHODS: RESPROTECT is a multicenter, open cohort, quadruple-blind, cluster-randomized, crossover trial. A total of 848 UVGI devices were installed in communal living areas of 12 nursing homes in the Haute-Loire region, France. All devices are switched on, but some contain internal filters that deactivate UV light while remaining indistinguishable from the outside. Centers were randomized 1:1 into two groups: unfiltered UVGI devices active during period 1 (October 2024-April 2025), then filtered (inactive) during period 2 (October 2025-April 2026), or the reverse sequence. The primary outcome is the incidence of severe ARIs. Secondary outcomes include the incidence of ARIs of any grade, all-cause hospitalization or death, adverse events of interest (keratitis and erythema), antibiotic consumption, airborne and surface pathogen loads, and cost-effectiveness. All analyses will follow the intention-to-treat principle and use mixed-effects Poisson regression models with fixed effects for period and random effects for clusters, cluster-periods and individuals. DISCUSSION: RESPROTECT is one of the first large-scale blinded randomized trials to evaluate the clinical effectiveness of UVGI in preventing respiratory infections among elderly residents in nursing homes. It will complement recent findings from the PETRA trial (JAMA Intern Med 2025) and is designed to provide robust data on both clinical outcomes and environmental contamination. If UVGI proves effective, it could represent a practical, low-maintenance, and scalable infection-prevention strategy for high-risk institutional settings. TRIAL REGISTRATION: French RCB identifier: RECHMIE-22-0003 - 2024-A00199-38. CLINICALTRIALS: gov Identifier: NCT06569160 (Registered on August 21, 2024). https://clinicaltrials.gov/study/NCT06569160.
Effect of crystalloid preloading on hypotension during propofol sedation for gastroenteroscopy: a prospective, randomized controlled study protocol.
Gao Z, Chen W, Wu X … +4 more , Wu T, Meng X, Wang G, Zhang X
Trials · 2026 May · PMID 42163298 · Full text
BACKGROUND: Propofol sedation for gastroenteroscopy, with advantages such as safety and comfort, is popular among a large number of patients. However, more than one-third of patients receiving propofol sedation experienc...
BACKGROUND: Propofol sedation for gastroenteroscopy, with advantages such as safety and comfort, is popular among a large number of patients. However, more than one-third of patients receiving propofol sedation experience intraoperative hypotension (IOH), which should not be ignored in patients of any age. The therapeutic effect of preloading in various in-operating-room anesthesias has been confirmed and widely applied. However, there are relatively few studies on preloading in outpatient intravenous anesthesia at home and abroad, and the required dose for preloading has not been explored. METHODS: This is a prospective randomized, single-center controlled trial. A total of 606 eligible participants scheduled for painless gastroenteroscopy will be enrolled and randomly assigned in a 1:1 ratio to either receive crystalloid preloading or no fluid infusion. The primary outcome of our study is the incidence of IOH. Secondary outcomes include inferior vena cava collapse index (IVC-CI), ΔIVC-CI, intraoperative dosage of ephedrine, BP (blood pressure), HR (heart rate), SpO (peripheral oxygen saturation), perfusion index, recovery time, and incidence of postoperative adverse reactions. DISCUSSION: This study aims to explore the impact of a certain dose of crystalloid preloading on the incidence of intraoperative hypotension during propofol-sedated gastroenteroscopy, in order to provide a reference for hemodynamic management in painless gastroenteroscopy. TRIAL REGISTRATION: ChiCTR ChiCTR2400082021. Registered on March 19, 2024.
The clinical and cost-effectiveness of elective primary total knee replacement with PAtellar Resurfacing compared to selective patellar resurfacing: a pragmatic multicentre randomised controlled Trial with blinding (PART) - statistical analysis plan.
Evans RN, Judge A, Matharu GS … +3 more , Petrie MJ, Blom AW, Pike K
Trials · 2026 May · PMID 42163296 · Full text
BACKGROUND: The PAtellar Resurfacing compared to selective patellar resurfacing Trial (PART) is a randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of selective patellar resurfacing (intra...
BACKGROUND: The PAtellar Resurfacing compared to selective patellar resurfacing Trial (PART) is a randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of selective patellar resurfacing (intraoperative decision by surgeon) compared to always patellar resurfacing in patients undergoing elective primary total knee replacement (TKR). This paper presents the PART statistical analysis plan, detailing the trial analysis and presentation plan. The proposed analysis follows recommendations from the International Council for Harmonisation guideline on Good Clinical Practice and "Guidelines for the Content of Statistical Analysis Plans in Clinical trials" and are in line with the Consolidated Standards of Reporting Trials. METHODS/DESIGN: PART is a multi-centre, randomised, blinded, pragmatic parallel two-group superiority RCT aiming to recruit 990 patients undergoing primary TKR. The primary outcome is the Oxford Knee Score (OKS) 12 months after TKR surgery. The planned statistical analyses of the trial primary and secondary outcomes are described in detail, including approaches to deal with the following: missing data, multiple testing, violation of model assumptions, withdrawals from the trial, non-adherence with the treatment and other protocol deviations. DISCUSSION: This manuscript prospectively describes, prior to the completion of data collection and database lock, the analyses to be undertaken for the PART trial to reduce the risk of reporting bias and data-driven analyses. TRIAL REGISTRATION: The trial was registered as ISRCTN33276681 on 27 Feb 2023, before recruitment began.
A megastudy of behavioral interventions to promote frequent HIV testing among adults at high risk of HIV infection in Kenya and Uganda: study protocol for a randomized controlled trial.
Marson K, Kabami J, Buttenheim AM … +7 more , Bennett D, Petersen ML, Havlir DV, Kamya MR, Ayieko J, Thirumurthy H, Chamie G
Trials · 2026 May · PMID 42163283 · Full text
BACKGROUND: Frequent HIV testing among people at high risk of HIV infection is critical for early diagnosis and prompt antiretroviral therapy (ART) initiation for those who test HIV positive, as well as provision of effe...
BACKGROUND: Frequent HIV testing among people at high risk of HIV infection is critical for early diagnosis and prompt antiretroviral therapy (ART) initiation for those who test HIV positive, as well as provision of effective biomedical HIV prevention modalities like pre-exposure prophylaxis (PrEP) for those who test negative. Despite World Health Organization (WHO) guidelines recommending retesting for HIV every 3-6 months for adults at increased risk, regular retesting is infrequent in sub-Saharan Africa. Large-scale, multi-arm field experiments ("megastudies") can evaluate many different behavioral interventions among the same population and at the same time rapidly identify behavioral solutions and overcome the challenge of comparing results across standalone trials. We describe the protocol for a megastudy that will simultaneously test multiple low-cost behavioral interventions to increase HIV retesting among adults at high risk of HIV infection in rural Kenya and Uganda. METHODS: We will conduct a 12-arm randomized trial of light-touch ("nudge") behavioral interventions among 30,000-40,000 HIV-uninfected adults aged ≥ 15 years in western Kenya and southwestern Uganda who self-report increased risk of HIV infection and have access to a mobile phone. Following a baseline HIV-negative test at a high-volume HIV testing center, participants will be individually randomized in parallel to one of 12 arms, including 10 different intervention arms comprising low-cost messages that serve as nudges for retesting, an intervention arm with a financial incentive for retesting, or a control arm with standard of care post-test counseling services. The primary outcome will be HIV retesting at any study venue 3-6 months after the initial baseline HIV test. We will also measure HIV-positivity, linkage to care and ART initiation, and PrEP referral acceptance at follow-up. DISCUSSION: This study will provide new information on low-cost interventions to promote HIV retesting for adults at elevated risk of infection in East Africa. The methods and results of this study will provide valuable insights for those engaged in HIV service delivery and influence how researchers and programs design and test low-cost, scalable interventions to promote health behaviors. TRIAL REGISTRATION: ClinicalTrials.gov NCT06971367. Registered on May 6, 2025, https://clinicaltrials.gov/study/NCT06971367.
Preventive effects of active Protocol-Based Pharmacotherapy Management for delirium in general wards of emergency department (aPBPM trial): study protocol for a single-center, randomized controlled trial {1a}.
Takatani Y, Sato Y, Sugita N … +7 more , Abe H, Yamane M, Yamanaka Y, Takeda M, Minami T, Terada T, Ohtsuru S
Trials · 2026 May · PMID 42163281 · Full text
BACKGROUND: Delirium is a frequent complication in older patients admitted to emergency wards, leading to prolonged hospitalization and increased mortality. Although multicomponent interventions are recommended, the evid...
BACKGROUND: Delirium is a frequent complication in older patients admitted to emergency wards, leading to prolonged hospitalization and increased mortality. Although multicomponent interventions are recommended, the evidence for pharmacological prevention remains inconsistent. Protocol-Based Pharmacotherapy Management (PBPM) allows pharmacists to actively manage medications according to a pre-agreed protocol. This study aims to evaluate the efficacy and safety of an "Active PBPM" strategy for delirium prevention compared with that via a standard "Passive PBPM" strategy in elderly emergency patients. METHODS: This single-center, open-label, randomized controlled trial will target patients aged ≥65 years admitted to the general ward of the Department of Primary Care and Emergency Medicine from the emergency room. Eligible patients must have at least one risk factor (e.g., cognitive dysfunction, central nervous system disease). The patients will be randomized (1:1) into either the Active or Passive PBPM group. In the Active PBPM group, pharmacists will intervene to administer prophylactic medication for 3 days, starting on admission day 1. Patients capable of oral intake will receive ramelteon (8 mg) and lemborexant (5 mg) at bedtime. Patients unable to take oral medication will receive a blonanserin patch (20 mg) applied overnight (19:00-06:00). In the Passive PBPM group, pharmacological intervention will be performed only if insomnia occurs. The primary outcome will be the incidence of delirium diagnosed by a psychiatrist based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria, within the first 3 days. The secondary outcomes include delirium severity (Delirium Rating Scale-Revised-98), assessed by trained nurses, and safety. DISCUSSION: This study will determine whether pharmacist-led proactive pharmacological intervention (Active PBPM) reduces the incidence of delirium in high-risk older patients in acute care settings. The findings may establish a new standard of care for the prevention of delirium in emergency medicine. TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT) jRCTs051220122. Registered on November 25, 2022.
Dysphagia Evaluation after Stroke through Intervention with oral neuromuscular training for REhabilitation of swallowing dysfunction (DESIRE): study protocol for a multicenter randomized controlled trial.
Hägglund P, Bergström L, Forsgren J … +7 more , Holmlund T, Liv P, Levring Jäghagen E, Mirkoska V, Romanitan M, Selg J, Wester P
Trials · 2026 May · PMID 42157318 · Full text
BACKGROUND: Stroke affects over 1 million people in Europe and 25,000 in Sweden annually, with high mortality and disability rates. Dysphagia, a common post-stroke issue, occurs in over 50% of patients in the acute phase...
BACKGROUND: Stroke affects over 1 million people in Europe and 25,000 in Sweden annually, with high mortality and disability rates. Dysphagia, a common post-stroke issue, occurs in over 50% of patients in the acute phase. Evidence-based studies are lacking on rehabilitative interventions to improve post-stroke dysphagia. Current management focuses on compensatory strategies, but oral neuromuscular training shows promising results. Challenges to rehabilitation programs include poor adherence and the need for effective monitoring technologies. The primary objective of the current trial is to investigate the impact of oral neuromuscular training with a sensor-equipped oral device on post-stroke dysphagia. METHODS: This national, multicenter, investigator-initiated, randomized, parallel-group trial compares the effect of oral neuromuscular training versus standard care in patients with post-stroke dysphagia. We will enroll 336 consecutive participants who have no prior history of dysphagia and exhibit persistent dysphagia 3 months following the onset of ischemic stroke or intracerebral hemorrhage. Participants will be randomly assigned in a 1:1 ratio to receive either a 12-week intervention consisting of standard routine care combined with oral neuromuscular training (using an oral device with sensors for adherence feedback) or current routine care alone. Standard routine care includes compensatory strategies such as bolus modification, adapted swallowing postures, and maneuvers. The primary outcome is the degree of dysphagia at end of intervention, assessed with Flexible Endoscopy Evaluation of Swallowing (FEES) by blinded evaluators, and analyzed with ordinal regression models. Secondary outcomes are changes in nutritional status, pneumonia, mortality, and quality of life after a 12-week intervention and at 6-month follow-up. DISCUSSION: This first randomized clinical trial in stroke rehabilitation on neuromuscular oropharyngeal training with sensors to facilitate adherence and comprehensive outcome measures will enable evaluation of this treatment with the potential for significant clinical impact for patients with dysphagia after stroke. TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT02960737. First registered on 11 November 2016 and later modified to the present multicenter study design on 22 August 2023.
Cost-effectiveness of a smartphone-based personalized lifestyle intervention for symptoms of depression in primary care: protocol for a cluster-randomized controlled trial (LIDIAS).
Jagtenberg EM, Ligthart SA, Muilwijk OG … +6 more , Akkermans RP, Spoelder M, Burger H, Maarsingh OR, Assendelft WJJ, Hartman TCO
Trials · 2026 May · PMID 42157297 · Full text
BACKGROUND: Depression is common and mostly managed in primary care. In the Netherlands, general practitioners (GPs) and mental health nurses (GP-MHNs) generally start with education and lifestyle advice, yet the latter...
BACKGROUND: Depression is common and mostly managed in primary care. In the Netherlands, general practitioners (GPs) and mental health nurses (GP-MHNs) generally start with education and lifestyle advice, yet the latter remains underused despite evidence of its effectiveness. Smartphone-based eHealth tools may help integrate lifestyle interventions into routine care by offering personalized support and monitoring. This study evaluates the (cost-)effectiveness of a Personalized eHealth Lifestyle Intervention (PLI) delivered via a smartphone app for patients with symptoms of depression in primary care. METHODS: This multicenter, cluster-randomized controlled trial will be conducted in Dutch general practices. Practices will be randomized (1:1), stratified by region and area-level socioeconomic status, into two groups: (1) intervention group including care as usual plus the PLI, or (2) control group including care as usual plus a monitoring app. Within the PLI, patients will use an app for 6 months to set lifestyle goals, monitor progress in lifestyle behavior, and track symptoms of depression and anxiety. GPs and GP-MHNs will have access to patient progress through a web-based version. Control group patients will use a similar app for symptom tracking only. The primary outcome is the change in severity of symptoms of depression assessed with the Patient Health Questionnaire-9 (PHQ-9). Secondary outcomes include lifestyle behaviors, satisfaction with lifestyle, anxiety symptoms, patient satisfaction with treatment by GP and GP-MHNs, mental health-related quality of life, social support, use of antidepressants, use of anxiolytics, and utilization of medical and mental health services. Cost-effectiveness will also be evaluated. A total of 105 patients per arm (PHQ-9 ≥ 5) will be recruited. DISCUSSION: The results of this study will provide valuable insights into the clinical and economic impact of a digital lifestyle support tool. This trial aims to contribute to more accessible, personalized, sustainable, and cost-effective care for people with symptoms of depression in primary care. TRIAL REGISTRATION: ClinicalTrials.gov NCT07022184. Registered on June 22, 2025.
Virtual reality exposure therapy with graded interviewer reactions for public speaking anxiety in university students: a randomized controlled trial protocol.
Kim M, Jeon M, Lee Y … +8 more , Lee Y, Yu S, Lee S, Kim H, Cho CH, Cho CY, Hur JW, Jung D
Trials · 2026 May · PMID 42157290 · Full text
BACKGROUND: Public speaking anxiety (PSA) significantly impairs academic and professional outcomes among university students. While virtual reality exposure therapy (VRET) shows promise for PSA treatment, the specific co...
BACKGROUND: Public speaking anxiety (PSA) significantly impairs academic and professional outcomes among university students. While virtual reality exposure therapy (VRET) shows promise for PSA treatment, the specific contribution of social and emotional interviewer reactions remains unclear. This study examines whether VRET with graded interviewer reactions leads to greater reduction in public speaking anxiety than standard automated VR exposure. METHODS: This two-arm, parallel-group, superiority randomized controlled trial will recruit 92 Korean university students aged ≥18 years with elevated PRPSA (Personal Report of Public Speaking Anxiety-18 ≥ 58). Participants will be randomized 1:1 to receive either VR interview training with graded interviewer reactions or control VR training with automated voice prompts only. The intervention consists of three VR sessions, with assessments conducted at baseline, immediately after each session, and at 6- and 12-week follow-ups. The primary outcome is change from baseline in Public Speaking Anxiety Scale (PSAS) total scores at each post-baseline assessment occasion, analyzed using a linear mixed-effects model including fixed effects for group, assessment occasion, and their interaction. Secondary outcomes include Liebowitz Social Anxiety Scale-Self Report and Fear of Negative Evaluation-Brief scores, as well as physiological indicators reflecting anxiety responses during VR exposure, including heart rate variability and electrodermal activity. Exploratory analyses will examine behavioral synchrony using motion energy analysis of video recordings and acoustic features of speech to capture anxiety-related movement and vocal patterns. DISCUSSION: This trial addresses the limited evidence regarding the added value of graded interviewer reactions in VRET for public speaking anxiety by examining whether they improve outcomes beyond those achieved with standard automated VR exposure. The findings may clarify the role of socially responsive feedback in virtual exposure and inform the development of VR-based anxiety interventions. TRIAL REGISTRATION: Clinical Research Information Service (CRiS) KCT0011111. Registered on 06 November 2025.
Evaluating the impacts of piperonyl butoxide-treated ceiling nets on malaria risk among high-risk populations with limited access to conventional LLINs in Homa Bay Country, Kenya: study protocol for a household randomized control trial.
Ko YK, Kagaya W, Kanoi BN … +3 more , Kongere J, Gitaka J, Minakawa N
Trials · 2026 May · PMID 42157279 · Full text
INTRODUCTION: Progress in reducing the global malaria burden has stalled since 2015, with increases in malaria incidence and mortality reported in many African countries after 2020. In 2021, the WHO issued a conditional...
INTRODUCTION: Progress in reducing the global malaria burden has stalled since 2015, with increases in malaria incidence and mortality reported in many African countries after 2020. In 2021, the WHO issued a conditional recommendation for house screening, including windows, ceilings, doors, and eave spaces, as a complementary intervention. However, evidence gaps remain, particularly regarding its effectiveness in combination with or as an alternative to long-lasting insecticide-treated nets (LLINs). This trial aims to evaluate the piperonyl butoxide-pyrethroid (PBO)-ceiling nets, a novel house screening tool covering ceilings, among high-risk households in Kenya with poor use of LLINs. METHODS: This trial includes both superiority and non-inferiority comparisons. Superiority comparisons will evaluate whether the combination of PBO-ceiling nets and PBO-LLINs provides greater protection than either intervention alone. Non-inferiority comparisons will assess whether PBO-ceiling nets alone are not inferior to PBO-LLINs alone in reducing malaria infection prevalence and entomological indicators. In Homa Bay County, Kenya, 500 households will be randomized into three arms: (1) receiving PBO-ceiling nets, (2) receiving PBO-LLINs at a ratio of one net per two household members, and (3) receiving both PBO-ceiling nets and PBO-LLINs. The primary outcome is the prevalence of Plasmodium infections by PCR among all age groups at 12 months post-intervention. Secondary outcomes include entomological indicators, such as the density of primary malaria vectors sampled using CDC light traps. DISCUSSION: This trial addresses key evidence gaps related to housing modifications for malaria prevention by evaluating the effectiveness of PBO-ceiling nets among high-risk populations with limited access to conventional LLINs. Although household-level randomization may limit the ability to capture potential spillover effects and introduce challenges such as open-label and observer biases, several measures have been incorporated to mitigate these risks, including frequent adherence reminders and blinding of laboratory and data analysis staff. Despite these limitations, the study is expected to generate important epidemiological and entomological data that will contribute to the evidence base for novel vector control strategies in malaria-endemic regions. TRIAL REGISTRATION: PACTR202506499755138. Registered on June 20, 2025.
Evaluation of a holiday card retention strategy: a study within a trial (SWAT) embedded in a blood pressure reduction trial.
Skolarus LE, Brown DL, Moraga A … +3 more , Hassani S, Dinh M, Meurer WJ
Trials · 2026 May · PMID 42157274 · Full text
INTRODUCTION: Participant retention is essential to minimize bias, preserve statistical power, and strengthen the validity of clinical trial findings. Although retention strategies are widely used, many lack rigorous eva...
INTRODUCTION: Participant retention is essential to minimize bias, preserve statistical power, and strengthen the validity of clinical trial findings. Although retention strategies are widely used, many lack rigorous evaluation. We evaluated whether sending a holiday card, compared with usual follow-up procedure, improves follow-up completion among clinical trial participants recruited from a resource-constrained emergency department. METHODS: We conducted a Study Within a Trial (SWAT) embedded within Reach Out, a 2 × 2 × 2 randomized trial of a mobile health-based behavioral intervention designed to reduce blood pressure among individuals with elevated blood pressure identified from a resource-constrained emergency department. All participants received standard retention strategies as part of the parent trial, with participants randomized to the SWAT intervention group additionally receiving a holiday card. The primary outcome was completion of the next available outcome assessment (6- or 12-month assessment). We estimated absolute differences with 95% confidence intervals in outcome assessment completion between participants who received a holiday card and those who did not, and then stratified by age, sex, and race. RESULTS: Among Reach Out participants (N = 395), 198 were randomized to receive a holiday card and 197 to receive no card. Outcome assessment completion did not differ between participants who received a holiday card and those who did not (54.5% vs 58.4%; p = 0.43), and there was no evidence of effect modification by age, sex, or race. CONCLUSION: In this low-resource setting, receipt of a holiday card was not associated with higher outcome completion. These findings are consistent with prior studies and suggest that multicomponent interventions may be needed to increase retention, underscoring the value of pragmatic evaluations of retention interventions embedded within ongoing trials.
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