Palombo P, Schmidt A, Akana N
… +12 more, Ryan R, Hovland S, Stark BC, Rodin N, Chaytor N, McDonell M, Burduli E, Layton M, Roll JM, Smith C, Miguel AC, McPherson S
BACKGROUND: Alcohol Use Disorder (AUD) has a significant negative impact on health and is associated with high morbidity and mortality rates. Despite the availability of pharmacological treatments, abstinence rates remai...BACKGROUND: Alcohol Use Disorder (AUD) has a significant negative impact on health and is associated with high morbidity and mortality rates. Despite the availability of pharmacological treatments, abstinence rates remain low, highlighting the need for novel therapeutic approaches. This study aims to evaluate the efficacy of combining Contingency Management (CM) with Zonisamide in promoting alcohol abstinence and reductions in alcohol use among individuals seeking AUD treatment. Additionally, this study will collect data on the Addiction Neuroclinical Assessment ANA framework to identify potential mediators or moderators of treatment outcomes. METHODS: This is a randomized, double-blind, controlled trial involving individuals diagnosed with AUD seeking treatment. Following a two-week induction period, eligible participants will be randomly assigned in equal proportions to one of two 12-week treatment conditions: CM + Zonisamide (experimental condition) or CM + Placebo (control condition). The primary outcome is biochemically verified alcohol abstinence assessed using repeated urine ethyl glucuronide (EtG) testing across the 12-week randomized treatment phase. Both groups will receive incentives for submitting alcohol samples during the first two weeks (induction phase). From weeks three to six, incentives will be contingent on providing alcohol-negative samples. Finally, from weeks seven to fourteen, incentives will be based on medication adherence. Follow-up assessments will be conducted at one, six- and twelve-months post-treatment. CONCLUSIONS: If effective, this treatment could provide significant advancements in AUD treatment by offering a novel, integrated approach to reduce alcohol use. Furthermore, the findings may contribute to a deeper understanding of how ANA-based responses influence treatment outcomes, facilitating the development of more personalized AUD treatment approaches.
Young S, Smothers A, Petitte T
… +7 more, Fink P, Beaver M, Melnick H, Mbadiwe J, Carey A, Smith C, Piamjariyakul U
Contemp Clin Trials
· 2026 Jun · PMID 41985659
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BACKGROUND: Recruiting participants for clinical trials in rural regions is challenging due to geographic isolation, transportation barriers, limited healthcare infrastructure, and longstanding mistrust of research. An N...BACKGROUND: Recruiting participants for clinical trials in rural regions is challenging due to geographic isolation, transportation barriers, limited healthcare infrastructure, and longstanding mistrust of research. An NIH-funded randomized controlled trial (RCT) is underway to evaluate a nurse-led home care intervention for patients with advanced heart failure (HF) in rural Appalachia. PURPOSE: This paper describes systematic strategies for screening, recruitment, and enrollment of older adults with HF and their primary caregivers in rural settings. METHODS: Recruitment occurs through outpatient HF clinics and referrals from faith-based nurses native to rural counties in West Virginia. Strategies emphasize cultural sensitivity and community engagement, including comprehensive staff training, proactive outreach, flexible scheduling, and IRB-approved incentives. RESULTS: Eight months after IRB approval and staff training, 66 families have enrolled, representing 64.7% of the target enrollment goal. Enrollment is ongoing and progressing as planned. Challenges include unclear HF diagnoses in medical records, missing caregiver contact information, and communication barriers such as outdated phone numbers and reluctance to answer unfamiliar calls. These issues are addressed through systematic documentation, repeated follow-up, and leveraging trusted community networks. DISCUSSION: Culturally tailored, community-based approaches effectively mitigate enrollment barriers in rural populations. Collaboration with local clinic staff and faith-based nurses fosters trust, improves access, and supports retention of participants with serious illness. Structured processes grounded in cultural understanding and local partnerships are essential for successful trial implementation in rural Appalachia.
BACKGROUND: The Canadian Adaptive Platform Trial of Treatments for COVID in Community Settings (CanTreatCOVID) is a multi-provincial adaptive platform trial (APT) evaluating outpatient therapeutics for individuals with m...BACKGROUND: The Canadian Adaptive Platform Trial of Treatments for COVID in Community Settings (CanTreatCOVID) is a multi-provincial adaptive platform trial (APT) evaluating outpatient therapeutics for individuals with mild to moderate SARS-CoV-2 infection at high risk of severe outcomes. Conducted across six Canadian provinces from January 2023 to March 2025, this paper describes its implementation and lessons for future APTs. METHODS: We conducted a structured reflection on trial implementation across six domains: governance, stakeholder engagement, recruitment strategies, consent and enrollment processes, operational challenges, and cross-trial collaboration. Insights were derived from documentation of trial operations, governance records, protocol amendments, monitoring reports, and discussions among trial leadership and committee members. Lessons were synthesized across domains and translated into recommendations to support future APT implementation. RESULTS: CanTreatCOVID highlighted the need for a centralized governance model. While the Steering Committee and Data Safety Monitoring Committee provided strategic oversight and safety monitoring, complementary committees for statistical methods, therapeutic selection, and recruitment addressed trial-specific needs. Regular stakeholder engagement supported trial design and implementation. Proactive communication with ethics boards facilitated regulatory approvals. Pre-negotiated agreements and national ethics review pathways were critical enablers accelerating site activation. Recruitment required multi-faceted strategies that adapted to evolving standards of care, supported by flexible, remote consent and online screening processes that reduced participant burden. Finally, aligning eligibility criteria, outcomes, and analytic approaches with international APTs enabled pooled analyses and strengthened evidence generation. CONCLUSION: CanTreatCOVID demonstrates feasibility of decentralized APTs in community settings. These lessons and recommendations provide a framework to optimize future APTs. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05614349).
BACKGROUND: More than 40% of Department of Veterans Affairs (VA) patients have a body mass index (BMI) ≥30 kg/m but only a fraction of eligible Veterans lose clinically meaningful weight in VA's national MOVE! Weight Man...BACKGROUND: More than 40% of Department of Veterans Affairs (VA) patients have a body mass index (BMI) ≥30 kg/m but only a fraction of eligible Veterans lose clinically meaningful weight in VA's national MOVE! Weight Management Program. Incorporating partners into weight management and developing a team approach to behavior change is a promising strategy to improve outcomes, but few such interventions have been adequately tested. We are testing HealthyTogether - a virtual, dyadic weight management program combining MOVE! weight management content and skills from interpersonal therapies - to determine whether HealthyTogether improves weight loss over usual care. METHODS: Dyads (N = 160) including (1) a Veteran with a BMI ≥ 30 kg/m and (2) a partner of their choice (e.g., spouse, family member, friend) are randomized 1:1 to usual care (control) or usual care plus HealthyTogether (intervention). HealthyTogether dyads receive eight synchronous video visits with a psychologist, social worker, or trainee over 14 weeks covering evidence-based behavioral weight management strategies and communication skills training and practice. The primary outcome is study-measured Veteran weight change in pounds at 6 months, with secondary outcomes of electronic health record-derived 6- and 12-month changes in Veteran weight, and 6-month changes in diet quality, physical activity, and relationship quality among Veterans and partners. DISCUSSION: This trial tests whether a brief, remote, dyadic weight management program can promote weight loss among Veterans. If effective, the HealthyTogether program could be implemented within and outside VA to improve health behaviors and weight loss outcomes among the growing number of individuals with elevated BMIs. CLINICAL TRIALS REGISTRATION: Clinicaltrials.gov (NCT06619041).
BACKGROUND: High blood pressure (BP) significantly increases the risk of adverse cardiovascular outcomes. Most adults with hypertension live in South Asia, yet only a small proportion have controlled BP. Patient-focused...BACKGROUND: High blood pressure (BP) significantly increases the risk of adverse cardiovascular outcomes. Most adults with hypertension live in South Asia, yet only a small proportion have controlled BP. Patient-focused strategies are needed to improve BP control. Although digital health interventions, such as text messaging show promise, they remain underexplored in India. We aim to evaluate the effectiveness of a text-messaging intervention to reduce BP in patients with uncontrolled hypertension. METHODS: This will be a prospective, randomized open-label trial with blinded endpoint assessment (PROBE) among patients with uncontrolled hypertension recruited from a tertiary-care public hospital setting in India. Eligible participants will be randomized to receive either tailored text messaging intervention or usual care. The intervention will include daily SMS medication reminders delivered in local language for three months, and weekly BP-focused health education message. Participants in the control arm will continue to receive standard hypertension care as advised by their treating physician. All randomized participants will be followed up at three-months for outcome assessment. Primary outcome measures include differences in systolic-BP and medication adherence at three months between intervention and control arm as assessed by mean change from baseline. DISCUSSION: The novelty of the present study lies in the utilization of text messages as a simple intervention for antihypertensive medication reminders and health education to reduce high BP. This is an innovative approach to engage patients in a country with a high disease burden and significant mHealth potential. TRIAL REGISTRATION: The trial is registered with the Clinical Trial Registry of India with reference number CTRI/2025/04/086053.
Gonzalez-Guarda RM, McCabe BE, Stafford AM
… +8 more, Nagy GA, Felsman IC, Solorzano R, Rocha-Goldberg P, Ortiz NG, Decena Sanchez Z, Lee Y, Cervantes RC
Contemp Clin Trials
· 2026 Jun · PMID 41980661
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BACKGROUND: Latinos, the largest racial and ethnic group in the US, experience declines in health while adapting to a new culture and context. Acculturative stress, the stress associated with this adaptation, and resilie...BACKGROUND: Latinos, the largest racial and ethnic group in the US, experience declines in health while adapting to a new culture and context. Acculturative stress, the stress associated with this adaptation, and resilience, the ability to overcome difficulties during this process, play important roles in influencing declines in health for both adults and youth. In fact, acculturative stress is the strongest social driver of the substance use, intimate partner violence, HIV, and mental health syndemic, conditions that cluster in marginalized communities. Yet there are limited interventions addressing acculturative stress and resilience in this population. This paper describes the protocol for SER Familia, a community-based intervention that uses a Syndemic Prevention Framework to address acculturative stress and promote resilience among Latino immigrant families. METHODS: A total of 380 immigrant parents and youth dyads are being enrolled and randomized to the SER Familia program (six sessions with families and groups) or a delayed intervention condition. The intervention is delivered by community health workers who work with families to improve family health by reducing acculturative stress and enhancing resilience (coping, ethnic pride, and social support). One parent and one child from each family will complete standardized and culturally specific measures four times (pre-intervention baseline and 3-, 6-, 12-month follow-ups) to determine the effectiveness in preventing or reducing syndemic outcomes (Aim 1) and to describe the mechanisms of change of the intervention (Aim 2) using mixed-methods. DISCUSSION: Findings have important implications for health promotion and disease interventions for Latinos and other immigrant populations.
BACKGROUND: Vegan diets provide health benefits for adults, particularly African American adults who have disproportionate rates of overweight or obesity. Restaurant-based interventions are a potential means to encourage...BACKGROUND: Vegan diets provide health benefits for adults, particularly African American adults who have disproportionate rates of overweight or obesity. Restaurant-based interventions are a potential means to encourage vegan diets for African American adults but there is limited dissemination and implementation (D&I) research on restaurant-based interventions in general or specifically in this context. OBJECTIVES: To report the protocol, methods and design of the Nutritious Eating with Soul D&I (NEW Soul D&I) study, a type II hybrid effectiveness trial lasting 12 weeks for African American adults. METHODS: The study will partner with two vegan soul food restaurants to implement the program. African American adults with overweight or obesity will be randomized to: (1) weekly nutrition classes plus weekly meal vouchers or (2) weekly meal vouchers plus one class at the end. Effectiveness outcomes are changes in body weight, blood pressure, and diet quality. Implementation outcomes are acceptability, appropriateness, cost, fidelity, and feasibility. CONCLUSIONS: NEW Soul D&I seeks to improve the health of African American adults and test and refine a packaged intervention for broader dissemination and reach in vegan soul food restaurants in the southeastern United States.
Contemp Clin Trials
· 2026 Jun · PMID 41974413
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The older Alaska Native/American Indian (AN/AI) population is increasing faster than their U.S. peers overall, yet AN/AI peoples are less likely to receive palliative care, including advance care planning (ACP). ACP aims...The older Alaska Native/American Indian (AN/AI) population is increasing faster than their U.S. peers overall, yet AN/AI peoples are less likely to receive palliative care, including advance care planning (ACP). ACP aims to align care with patient priorities and can improve health-related quality of life for people with serious illness and their families, including a reduction in psychological distress, physical symptoms, unwanted treatments, and cost. ACP ideally includes documentation of advance directives to guide medical decisions when patients cannot speak for themselves. AN/AI peoples are more likely to engage in palliative care services, including ACP, when they are culturally tailored, yet few such evidence-based interventions exist. In a previous study, we used community engaged methods to tailor and pilot the Jumpstart ACP communication intervention with 58 AN/AI adult patients with serious illness in an Alaska Native health system. That study found the tailored Jumpstart to be highly acceptable and feasible but was not statistically powered to evaluate intervention efficacy. This paper describes the protocol for a fully-powered, cluster randomized, type 1 hybrid effectiveness-implementation trial of the tailored Jumpstart among 400 AN/AI adults in Alaska. This study will provide critical evidence for improving serious illness care outcomes and health equity in AN/AI communities.
The monitoring of adverse events is a well-established practice for clinical trials evaluating medications and medical devices. However, most psychological health and psychotherapy clinical trials either do not report or...The monitoring of adverse events is a well-established practice for clinical trials evaluating medications and medical devices. However, most psychological health and psychotherapy clinical trials either do not report or limit adverse event monitoring to serious adverse events such as suicide attempts and psychiatric hospitalizations. Some potential adverse events, such as temporary increases in anxiety, are often considered to be a normal part of psychotherapy and therefore may not be documented as adverse events. Without systematic and comprehensive reporting of adverse events, investigators and patients will never know the frequency or severity of problems encountered by patients and/or attributable to the therapy/treatment provided. The South Texas Research Organizational Network Guiding Studies on Trauma and Resilience (STRONG STAR Consortium) established a program for the routine reporting of adverse events or untoward changes in health for psychological health clinical trials that has been in use since the inception of the consortium. The adverse events monitoring program meets the Codes of Federal Regulations for human subjects research, International Conference on Harmonization, and good clinical practice guidelines for the assessment and documentation of possible adverse events in clinical trials. This manuscript outlines the STRONG STAR Adverse Events Monitoring Program for psychological health clinical trials including (1) the definitions of key terms, (2) the STRONG STAR approach to monitoring psychological health adverse events, (3) the processes and procedures of reporting, (4) an example of reporting, and (5) a call for standardized monitoring of adverse events as a routine practice in psychological health clinical trials.
Proof of Concept (POC) trials should be designed to inform a drug's targeted benefit-risk profile and ability to fulfill unmet medical needs, rather than simply achieving statistical significance. Pulkstenis et al. [1] p...Proof of Concept (POC) trials should be designed to inform a drug's targeted benefit-risk profile and ability to fulfill unmet medical needs, rather than simply achieving statistical significance. Pulkstenis et al. [1] proposed a unified Bayesian framework for decision-making in Proof of Concept (POC) trials to weigh evidence regarding a dual-level Target Product Profile (TPP). To accelerate decision-making while evidence is still emerging from a Phase 2 trial, we generalize this framework by incorporating interim monitoring leveraging predictive probability. An accelerated Go-decision can be achieved to initiate Phase 3 studies earlier if sufficiently promising results are observed, while an early No-Go or wait decision can be made when supporting evidence indictates. Practical guidance for implementing the approach is demonstrated by simulation studies of binary and continuous endpoints.
BACKGROUND: The intracluster correlation coefficient (ICC) is a critical parameter for determining sample size in cluster-randomized trials. However, accurate estimation of the ICC values are often challenging due to lim...BACKGROUND: The intracluster correlation coefficient (ICC) is a critical parameter for determining sample size in cluster-randomized trials. However, accurate estimation of the ICC values are often challenging due to limited availability from participating sites. Even small deviations from the assumed ICC can result in underpowered studies. METHODS: We used simulations to evaluate the performance of blinded internal pilot sample size re-estimation (SSRE) on the B-Free trial, a cluster crossover trial with 20 hospitals and 12 planned 4-weeks periods with postoperative delirium as primary outcome. The SSRE process included: (1) calculating the initial sample size, (2) collecting interim data, (3) estimating the ICC, (4) re-estimating the sample size, and (5) increasing the number of cluster-periods if needed. RESULTS: Across 1,000 simulations, interim ICC estimates closely matched true values when 25%, 50%, and 75% of the data were available, although variability was higher at 25%. Statistical power was restored to 80% and the Type I error was maintained at 5% when uncertainty in the ICC was modest (e.g., assumed 0.02 vs. observed 0.05). In the B-Free trial, the observed ICC at approximately 70% data availability closely approximated the final value. To achieve 81% power, the trial was extended by 5-6 periods at half of the participating sites. CONCLUSIONS: With at least 50% of interim data, ICC estimates are generally reliable, and SSRE preserves Type I error rate. Incorporating an internal pilot into the design of cluster crossover trials is an effective strategy to maintain statistical power when ICCs are modestly misspecified.
BACKGROUND: Chronic pain (CP) and early cognitive decline (ECD) disproportionately impact older Black adults. Our team developed and adapted Active Brains, our evidence-based program that uses mindfulness-based cognitive...BACKGROUND: Chronic pain (CP) and early cognitive decline (ECD) disproportionately impact older Black adults. Our team developed and adapted Active Brains, our evidence-based program that uses mindfulness-based cognitive therapy (MBCT), using cultural tailoring for older Black adults with CP-ECD comorbidity. This protocol paper describes Healthy Aging as Black Adults, In It Together (HABIT), a comparative-effectiveness trial of two evidence-based intervention programs - our culturally tailored adaptation of Active Brains, called MBCT with walking (MBCT+w), and Active Living Every Day (ALED). Our aim is to test which of the two comparators will be superior in improving health outcomes (physical, emotional, and cognitive function) among older Black adults with the CP-ECD comorbidity, and we will assess whether improvements are maintained over a 6-month follow-up. METHODS: We aim to recruit (N = 400) older, community-dwelling Black adults with CP-ECD comorbidity. Eligible participants are 50 years or older, with CP for 3 months or more, and meet screening criteria for early cognitive decline (ECD). Patients will be randomized to either culturally tailored MBCT+w or ALED, which are matched in intervention dosage, at 12 contact hours over 12 weeks (i.e., 720 min of group intervention), and delivered in person in group format. Data will be collected pre- and post-intervention and 6-months follow-up. We will conduct linear mixed effect models to estimate between-group differences for health outcomes over time. CONCLUSION: Findings will support the implementation of the superior program (MBCT+w or ALED) into community settings through a peer delivery modality to support older, community-dwelling Black adults with CP-ECD comorbidity. Clinical trial registration ClinicalTrials.gov Identifier #NCT06246929.
Salsman JM, Murphy KM, Addington EL
… +12 more, Tooze JA, McLouth LE, Yang D, Sanford S, Wagner L, Bunch SC, Rosenberg AR, Valle CG, Zebrack B, Howard D, Roth M, Moskowitz JT
SCOPE: ClinicalTrials.gov serves as a key resource for information on ongoing and completed clinical trials. To advance equitable promotion and broaden access, the Clinical Trials Search Tool (CTST) was developed to buil...SCOPE: ClinicalTrials.gov serves as a key resource for information on ongoing and completed clinical trials. To advance equitable promotion and broaden access, the Clinical Trials Search Tool (CTST) was developed to build on ClinicalTrials.gov data, offering a more comprehensive index with user-friendly geospatial, demographic, and socioeconomic features. AIM: To create a web-based Clinical Trials Search Tool (CTST) that builds on ClinicalTrials.gov data, offering custom querying, reporting functions, and interactive geospatial mapping capabilities. METHODS: The CTST was built using a rapid, iterative, feedback-driven Agile approach. Its front-end client, developed in Svelte and TypeScript with the SvelteKit framework and Tailwind CSS UI library, supports detailed search specifications and result rendering. Iterative means user-driven refinement of queries, adjusting keywords, filters, and geography based on results. This workflow enables dynamic exploration and optimization of feasibility queries. The back-end server, implemented in Java with Spring Boot framework, processes searches and delivers ranked results, storing application data in a PostgreSQL database. Communication occurs through the server's REST API via asynchronous HTTP requests with JSON-serialized data. RESULTS: The CTST, which enables both basic keyword-based searches as well as searches using advanced criteria, provides an easy-to-use interface for specifying input search criteria, allowing users to customize their selection. An interactive geospatial map renders the returned results as listings that summarize clinical trials in a tabular form, several layers that integrate population density, racial and ethnic demographics, and socioeconomic details. CONCLUSION: The CTST builds on the ClinicalTrials.gov database, integrating geospatial, demographic, and socioeconomic dimensions to support advanced research and maximize its value for clinicians and investigators.
BACKGROUND: Rural communities continue to experience high overdose mortality rates and challenges retaining individuals with opioid use disorder (OUD) on medications for opioid use disorder (MOUD). The most recent formul...BACKGROUND: Rural communities continue to experience high overdose mortality rates and challenges retaining individuals with opioid use disorder (OUD) on medications for opioid use disorder (MOUD). The most recent formulation of injectable extended-release buprenorphine (XR-BUP) may improve treatment engagement and outcomes for people with OUD. OBJECTIVES: The RXR study (CTN-0102XR) aims to evaluate the feasibility of implementing XR-BUP in rural settings, acceptability of XR-BUP to clinic staff and patients, and effectiveness of XR-BUP compared with sublingual buprenorphine-naloxone (SL-BUP). STUDY DESIGN AND METHODS: This is an open-label randomized controlled trial (RCT) using intention-to-treat (ITT) analysis. Approximately 144 participants recruited from seven rural clinic sites will be randomized to receive XR-BUP or SL-BUP in a ratio of 2:1, and will receive study medication for 14 weeks. Participants in the XR-BUP condition will receive two weekly initiation dosages, followed by the target monthly dosage (128 mg) at Weeks 2, 6, and 10. Participants in the SL-BUP condition will receive medication on a similar schedule, with a target dose range of 16-24 mg/day. The main comparative effectiveness outcome measure is the number of monthly opioid negative urine drug screens (UDS) for non-prescribed opioids from Weeks 2-14. Feasibility and acceptability will be evaluated using mixed methods, combining participant survey and interview data from clinic administrators, providers, and patients. CONCLUSIONS: If demonstrated to be feasible and acceptable to participants and staff and there is evidence of effectiveness for people with OUD in reducing opioid use, XR-BUP may be considered an important option for addressing OUD in rural settings. CLINICALTRIALS: gov Identifier: NCT06023459.
Coupet E, Dodington J, D'Onofrio G
… +9 more, Stover CS, Dziura J, Vega CP, Couvertier E, Latham E, Gawel M, Fiellin DA, Fretz SL, Vaca FE
Contemp Clin Trials
· 2026 May · PMID 41839387
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Emerging adults are disproportionately at risk for substance misuse and assault injury. Assault-injured emerging adults with substance misuse have increased risk of morbidity and mortality compared to those without and o...Emerging adults are disproportionately at risk for substance misuse and assault injury. Assault-injured emerging adults with substance misuse have increased risk of morbidity and mortality compared to those without and often receive care in the Emergency Department (ED). This manuscript describes the development of a protocol for a pilot randomized trial of an adapted brief behavioral intervention, the Brief Negotiation Interview (BNI), for use among assault-injured emerging adults with alcohol and/or cannabis misuse presenting to the ED. First, we will perform a mixed methods study of assault-injured emerging adults with alcohol and/or cannabis misuse to elicit the shared psychosocial risk factors that contribute to both alcohol and/or cannabis misuse in the context of assault injury. We will then use these data to adapt the BNI for use among assault-injured emerging adults with alcohol and/or cannabis misuse. We will evaluate the feasibility and acceptability of the adapted BNI in a randomized trial in the ED setting (N = 50). This pilot study is a critical initial step in developing an effective brief behavioral intervention for reducing alcohol and cannabis use among assault-injured emerging adults. Trial Registration Number NCT07070414.
Green DJ, Vasenina V, Meyerhoffer K
… +7 more, Banks RK, Hall MW, Zuppa AF, Watt KM, Dilts N, VanBuren JM, Eunice Kenedy Shriver National Institute for Child Health and Development's Collaborative Pediatric Critical Care Research Network
Contemp Clin Trials
· 2026 May · PMID 41833775
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BACKGROUND: High-quality conduct of clinical trials depends on strict adherence to both regulatory protocols and trial-specific procedures to ensure data integrity and participant safety. Standard methods utilized to tra...BACKGROUND: High-quality conduct of clinical trials depends on strict adherence to both regulatory protocols and trial-specific procedures to ensure data integrity and participant safety. Standard methods utilized to train research staff have limitations, including lack of specificity and declining impact over time. We developed a Supplemental, Reinforced, Risk-Based Training (SRRBT) program, designed to target study-specific challenges and provide ongoing reinforcement. Our objective was to evaluate whether SRRBT improves protocol adherence. METHODS: SRRBT was executed as a cluster-randomized, educational implementation study embedded in a multicenter clinical trial. We compared standard training with and without the addition of SRRBT across 23 clinical sites. SRRBT consisted of five interactive electronic vignettes focusing on trial-specific competencies. The primary outcome was the proportion of eligible participants approached for study participation. Secondary outcomes included consent and enrollment rates, protocol deviations, and completeness of study documentation. RESULTS: Approach rates immediately following training trended higher at SRRBT sites compared to those receiving standard training alone (OR = 3.98, 95% CI [0.87, 18.17], p = 0.074); however, this difference was not statistically significant and attenuated over time, with odds ratios of 2.24 (95% CI [0.78, 6.49], p = 0.14) at six months and 1.38 (95% CI [0.53, 3.59], p = 0.51) at 12 months post-training. CONCLUSIONS: SRRBT shows potential in enhancing early site-level protocol adherence but may require ongoing reinforcement to sustain benefits over time. This study highlights the need for continuous, adaptive training approaches in complex clinical trials to maintain high standards of protocol adherence.
Zhou JX, Onyeka OC, Carter JA
… +16 more, Myers A, Garcia A, Contreras-Muñoz J, Messerli MC, Dang B, Vieira A, Ahmed A, Ayton DM, Boedeker P, Guzick AG, Silva T, Moore HC, Trent ES, Candelari AE, Palo AD, Storch EA
Anxiety and obsessive-compulsive disorders are common among children and adolescents and, if left untreated, can lead to further psychiatric morbidity and impairment. Practical barriers, such as financial constraints, li...Anxiety and obsessive-compulsive disorders are common among children and adolescents and, if left untreated, can lead to further psychiatric morbidity and impairment. Practical barriers, such as financial constraints, limited availability of therapists, and time limitations of families, may impede access to evidence-based treatments. Low-intensity treatments show promise in addressing these barriers while conserving resources for those who require additional support. However, further empirical evidence is needed regarding the comparative efficacy of different interventions. To address this gap, we detail the protocol for a randomized controlled trial that compares the effectiveness of three different low-intensity therapy interventions - internet guided cognitive-behavioral therapy, parent-led treatment, and relaxation therapy - and explores the underlying mechanisms of each.
BACKGROUND: The effectiveness and implementation evaluation of evidence-based interventions are critical. PURPOSE: This study evaluated a multicomponent exercise (MCE) program for older adults who were not engaging in re...BACKGROUND: The effectiveness and implementation evaluation of evidence-based interventions are critical. PURPOSE: This study evaluated a multicomponent exercise (MCE) program for older adults who were not engaging in regular exercise at a private fitness center. METHODS: This randomized controlled trial recruited community-dwelling older adults who attended public lectures. The intervention group (IG) participated in MCE sessions that incorporated aerobics, muscle-strengthening, and balance exercises, once or twice weekly, for 12 weeks. The control group (CG) participants maintained their usual lifestyles. Physical function and activity levels were measured before and after the 12-week study period. Physical function measures included a 30-s chair stand, timed up-and-go (TUG) test, and one-leg standing test. Physical activity was evaluated using total exercise time (TET) and an accelerometer. Implementation outcomes were assessed for their reach, effectiveness, implementation, and maintenance using the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Program adherence and fidelity were also assessed. Between-group comparisons were performed using a linear mixed-effects model. RESULTS: Of 148 lecture attendees, 65 (43.9%) participated in the study. The IG (n = 32) showed significant differences in TUG (P < 0.001) compared to baseline, with significantly better TUG test performance (P = 0.004) than the CG. There was a 75% adherence rate with 12 or more sessions attended and 81.3% (26/32) of participants in IG continued the program for 24 weeks. CONCLUSION: The MCE program resulted in high adherence, fidelity, and improved mobility; it also promoted physical function and continued participation among older Japanese adults. Clinical Trial Registration UMIN Clinical Trials Registry (UMIN-CTR ID: UMIN000050860).
Walker DM, Spees C, Brock G
… +14 more, Williams A, Smith J, Shrodes J, Gilmore D, Headings A, Baker C, Price T, Roberts MW, Frey E, Tatro J, McGlade L, Derry H, Johnson K, Joseph JJ
BACKGROUND: Medicaid-enrolled populations are disproportionately impacted by suboptimal dietary intake leading to a high prevalence of Stage 2 cardiovascular-kidney-metabolic syndrome (CKMS), and lower Life's Essential 8...BACKGROUND: Medicaid-enrolled populations are disproportionately impacted by suboptimal dietary intake leading to a high prevalence of Stage 2 cardiovascular-kidney-metabolic syndrome (CKMS), and lower Life's Essential 8 (LE8) cardiovascular health (CVH) measures. METHODS: A pilot randomized controlled trial to test the feasibility, engagement, and preliminary efficacy of a novel Food-is-Medicine (FIM) intervention in Medicaid-enrolled adults with Stage 2 CKMS. SETTING: Participants were recruited from an academic medical center in an urban environment in the Midwest. DESIGN: Parallel group design. INTERVENTIONS: SUSTAIN tests a phased-approach over 24 weeks: Weeks 1-8: Instacart food vouchers (known as Fresh Funds) and home delivery, behavioral nutrition counseling and culinary education, community health worker (CHW)-led social needs coordination, and produce prescription via Mid-Ohio Farmacy (MOF) access; Weeks 9-16: study supported Instacart platform access without the vouchers (Fresh Funds), while other components remain the same; Weeks 17-24: option to continue Instacart without study support, counseling and culinary education cease, and MOF and CHW continue. Control participants receive the same intervention without counseling and culinary education or the CHW. OUTCOMES: Primary and secondary outcomes include study enrollment, adherence to intervention components (i.e., total Instacart spending, counseling sessions, number of food pantry visits, linkage with CHW), retention across study visits, acceptability (i.e, satisfaction), practicality (i.e., participant costs), adaptations to the intervention, and efficacy (i.e., dietary patterns, nutrition security, American Heart Association's Life's Essential 8). DISCUSSION: Scalable FIM approaches to improve CVH in individuals with Stage 2 CKMS are needed to inform inclusive and impactful interventions to address nutrition security. CLINICALTRIALS: gov: NCT06589336.