Contemporary clinical trials最新文献

Background: Black and Hispanic adults with diabetes are more likely to experience diabetes complications and die from diabetes compared to non-Hispanic whites. This disparity may be due to medication adherence being negatively affected by social determinants of health (SDOH) and negative beliefs about diabetes and diabetes medicines. Pharmacist delivered medication therapy management (MTM) improves clinical outcomes. However, pharmacists have limited capacity and expertise to address SDOH barriers and health misperceptions. Supplementing MTM with Community Health Workers (CHWs) to address these factors may be more effective with potential for implementation.

Aim: To investigate what combination of two possible components, pharmacist delivered MTM and CHWs addressing SDOH barriers and health misperceptions, represents the optimized intervention for Black and Hispanic adults with uncontrolled diabetes.

Methods/design: We will use a 2 × 2 factorial design (MTM, CHW: ON vs. OFF) where participants will be randomized to one of four treatment conditions in a 6-month intervention delivered mostly by phone. We will recruit 376 Black or Hispanic adults with type 2 diabetes and hemoglobin A1C of ≥8 %, a clinical indicator of uncontrolled type 2 diabetes. The primary outcome is A1C measured at 6 months, and at 12 months for sustained change. The secondary outcome is medication adherence. Several psychosocial factors will be examined as potential mediators. An embedded experimental mixed methods approach will be used to obtain participant perspectives through qualitative interviews and integrated to assess intervention acceptability.

Discussion: Our findings will identify the optimized intervention, e.g., comprising MTM or CHW or both intervention components, that effectively and efficiently improves diabetes outcomes among Black and Hispanic adults with uncontrolled diabetes, informing dissemination.

Background: The goal of the PROPEL-IT study is to conduct an effectiveness-implementation (hybrid type 1) study to 1) test the effectiveness of a digital technology focused 24-month, patient-centered precision public health approach to weight-loss, facilitated by an electronic medical record (EMR) in Black patients with obesity and type 2 diabetes mellitus or prediabetes, and 2) better understand the external validity and context for implementation.

Methods: Patients in the Intensive Lifestyle Intervention (ILI) participate in a high-intensity behavioral intervention to facilitate weight loss through reducing dietary intake and increasing physical activity. The ILI is delivered by health coaches in the digital medicine program of a large health care organization facilitated by the patient portal of their EMR. Patients in the usual care (UC) group continue to receive routine medical care from their health care team. The primary outcome is percent weight change from baseline. Study implementation is guided by the Consolidated Framework for Implementation Research (CFIR) and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) evaluative framework.

Results: Patient recruitment began on August 31, 2022 and was completed on January 22, 2024. During the ∼17-month recruitment period, 352 patients were recruited and randomized (176 to ILI; 176 to UC).

Conclusion: The results of this study will provide evidence on the effectiveness of a remotely delivered high-intensity weight loss program within a large health care organization, and provide important information regarding its implementation in a digital medicine setting.

Clinical trials registration number: NCT05523375.

Children's physical inactivity and increasing sedentary behaviour have become major public health concerns, with a concurrent decline in muscular fitness (MF) contributing to poor physical outcomes during childhood and adolescence, highlighting the importance of developing resistance training (RT) programs. Furthermore, several educational strategies such as gamification seem to increase students' motivation which can produce an increase in performance outcomes. This study describes the rationale and protocol of a school-based randomized controlled trial called "RETRAGAM" (REsistance TRAining based on GAMification). For this investigation, a total of ≃180 children (grades 5 and 6; 10-12 years of age) from 6 randomly selected schools in Valencia (Spain) will be enrolled for 8 weeks in one of the experimental groups: EG (15 min of RT Functional HIIT circuit program), EG + G (the same EG program but with a gamification approach) or CG (Control Group). Outcomes will include physical activity profile, MF, anthropometry and body composition, as well as the enjoyment and motivation during Physical Education (PE). An interactive app for digital devices will be used for gamified storytelling, earning points for personalized children's avatars, and implementing a flipped classroom learning model. We conclude that the RETRAGAM will provide information about the effectiveness and implementation of a school-based RT intervention during PE with and without gamification in students' MF, body composition, motivation and enjoyment.

Background: This paper outlines the protocol for the ecofit implementation-effectiveness trial, a multi-component mobile Health (mHealth) intervention that aims to increase resistance and aerobic physical activity in primary care-based adults with type 2 diabetes (T2D). This study will be conducted as part of the Diabetes Alliance Program Plus (DAP+), a large-scale integrated health service intervention in a large health district in Australia. The ecofit program has previously demonstrated efficacy and effectiveness in insufficiently active people with (or at risk of) T2D and community dwelling-adults, respectively. The aim of this study is to assess the reach (primary outcome), adoption, appropriateness, feasibility and fidelity of the implementation of ecofit and the overall effectiveness of the intervention.

Research design and methods: Prospective participants are adults diagnosed with T2D, who attend primary care settings enrolled in DAP+, and are identified and referred to ecofit by a primary care clinician. To support the implementation of ecofit a host of strategies will be utilised, which includes the education and upskilling of primary care clinicians enrolled in DAP+ using brief training sessions, the supply of an information package and access to professional development. The co-primary outcomes of reach will be defined as the number of participant registrations on the ecofit platform and the number of primary care clinicians who have been introduced to ecofit.

Conclusion: This study will evaluate the implementation of ecofit among adults with T2D within the primary care setting. The results may help improve T2D lifestyle interventions in primary care settings across Australia.

Background: Informal care partners (CPs) of persons with dementia (PWDs), who are at risk of negative health outcomes, benefit from psychosocial interventions. Individualized Coordination and Empowerment for CPs of PWDs (ICECaP) is a year-long, multi-component intervention comprised of in-person and telehealth psychoeducation and emotional support from dementia care coordinators (DCCs). ICECaP feasibility and acceptability were examined during a pilot randomized controlled trial.

Method: Feasibility was determined by study enrollment (relative to screening) and study completion. Acceptability was examined with CP-rated intervention satisfaction and DCC-completed surveys of CP engagement, using one-sample Wilcoxon tests to evaluate differences between observed and null hypothesized medians. Implementation fidelity was also evaluated. Analyses of variance and Chi-square tests identified demographic differences in study completion and DCC-reported CP engagement.

Results: Study enrollment (91.4 %) and study completion (85.4 %) were both high when compared to findings from a recent meta-analysis of CP psychosocial interventions. Completion was similar across groups (ICECaP vs. control) and demographics. CPs and DCCs communicated twice monthly, most commonly via email. On average, DCCs spent 68 minutes total per CP monthly; the number and duration of contacts varied widely. CPs responded positively on the satisfaction survey, and DCCs mostly responded positively about CP communication, engagement, and responsiveness. Communication was reportedly more difficult with employed CPs and CPs with ≥16 years of education.

Conclusion: ICECaP was both feasible and acceptable. DCC time spent with CPs occurred primarily virtually and varied widely, reflecting both individualization within the intervention and the unpredictability of dementia care for CPs.

Clinicaltrials: govNCT04495686.

Background: Hereditary cancer syndromes cause a high lifetime risk of early, aggressive cancers. Early recognition of individuals at risk can allow risk-reducing interventions that improve morbidity and mortality. Family health history applications that gather data directly from patients could alleviate barriers to risk assessment in the clinical appointment, such as lack of provider knowledge of genetics guidelines and limited time in the clinical appointment. New approaches allow linking these applications to patient health portals and their electronic health records (EHRs), offering an end-to-end solution for patient-input family history information and risk result clinical decision support for their provider.

Methods: We describe the design of the first large-scale evaluation of an EHR-integrable, patient-facing family history software platform based on the Substitutable Medical Applications and Reusable Technologies on Fast Healthcare Interoperability Resources (SMART on FHIR) standard. In our study, we leverage an established implementation science framework to evaluate the success of our model to facilitate scalable, systematic risk assessment for hereditary cancers in diverse clinical environments in a large pragmatic study at two sites. We will also evaluate the success of the approach to improve the efficiency of downstream genetic counseling resulting from pre-counseling pedigree generation.

Conclusions: Our research study will provide evidence regarding a new care delivery model that is scalable and sustainable for a variety of medical centers and clinics.

Trial registration: This study was registered on ClinicalTrials.gov under NCT05079334 on 15 October 2021.

Background: Despite youth's shift from Facebook to Instagram, the literature on how to use Instagram to recruit youth for clinical trials is scant. This paper reports procedures and comparative metrics on the use of Facebook and Instagram to recruit a nationwide sample (N = 1216) of LGBQ youth, aged 15 and 16 years, for an online drug abuse prevention trial.

Methods: Our recruitment campaign used ads on Facebook and promoted posts on Instagram. Ads and posts shared common images, headlines, and captions. Ads and posts directed youth to a study recruitment website for informed consent and enrollment procedures.

Results: Our campaign ran for 48 non-consecutive days, yielded N = 1216 participants, had a total cost of $25,400.31, and an average cost per participant of $20.89. Facebook ads and Instagram promoted posts ran for a similar number of days. However, compared to Instagram, Facebook ads cost more than twice as much (115 %), had 51 % fewer clicks, and had an average cost-per-click that was 338 % higher. Furthermore, despite being shown to users more than 4 times as often and garnering more than twice as many unique views, Facebook ads had a click-through-rate that was 90 % lower than Instagram promoted posts.

Conclusion: Instagram promoted posts outperformed ads on Facebook by driving more potential participants to the study recruitment website and for less money.

Background: The Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation (RED-AF) trial is a multi-site, randomized controlled clinical trial examining the effectiveness of a patient decision aid and an encounter decision aid in promoting shared decision-making (SDM) during a clinical encounter for patients with atrial fibrillation (AF). We sought to describe baseline characteristics of patients and clinicians in the trial and compare them to the demographics of the larger AF population. We also conducted an analysis of possible predictors of attrition rates at baseline, 6 and 12 months.

Methods: This study was a multi-center randomized controlled trial conducted at six academic centers across the U.S. Patients with non-valvular AF who qualify for anticoagulation therapy were eligible for enrollment. Patient demographics and characteristics were evaluated via questionnaires after their baseline clinical encounter. Participating clinicians completed demographic surveys, reporting educational background, specialty, and years of experience. Patient characteristics were analyzed via univariate logistic regression to identify potential trends among those lost to follow-up at each timepoint.

Findings: A total of 1117 patients were enrolled in the RED-AF trial, with an average age of 69 (SD 9.3). Patients were predominantly male (61.7 %) and white (89.1 %), with 33.7 % reporting graduate or professional education. Clinicians (N = 107) were enrolled from specialties including cardiology (68.2 %), internal medicine (13.1 %), and pharmacy (14.0 %). No significant associations were found between any measured patient characteristics with survey completion at baseline, 6 or 12 months.

Conclusion: The baseline demographics of the RED-AF trial reflect that patient participants were largely similar to prior studies investigating shared-decision making in patients with AF. The lack of association between patient demographics and attrition rates may highlight equity across the tested subgroups for survey completion for the study as a whole.

Background: Linkage to medical services is key to early detection, diagnosis, and care for dementia. Yet, racial and ethnic minoritized older adults and their caregivers are particularly vulnerable to inequity in dementia care due to limited dementia literacy. Mobilizing community resources such as community health workers (CHWs) can benefit older patients and their caregivers who are challenged by linguistic barriers and low health literacy.

Methods: Preparing for healthy aging through dementia Literacy education And Navigation (PLAN), is a CHW-led intervention program designed to promote linkage to medical services for dementia and caregiver outcomes in a multi-site clinical trial in the Greater Washington and New York metropolitan areas. This protocol describes the rationale, design, and methods of the PLAN trial.

Conclusion: We recruited 288 dyads of eligible Korean American older adults with undiagnosed dementia and their caregivers, totaling 576 participants. Data collection is ongoing. Findings from this trial will contribute to knowledge around identifying community-dwelling older adults with probable dementia with limited health resources as well as navigating appropriate medical evaluation and support.

Clinicaltrials: gov identifier: NCT03909347.

Background: Primary results from randomized clinical trials (RCT) only inform on the average treatment effect in the studied population, and it is critical to understand how treatment effect varies across subpopulations. In this paper we describe a clustering-based approach for the assessment of Heterogeneity of Treatment Effect (HTE) over patient phenotypes, which maintains the unsupervised nature of classical subgroup analysis while jointly accounting for relevant patient characteristics.

Methods: We applied phenotype-based stratification in the ENGAGE AF-TIMI 48 trial, a non-inferiority trial comparing the effects of higher-dose edoxaban regimen (direct anticoagulant) versus warfarin (vitamin K antagonist) on a composite endpoint of stroke and systemic embolism in 14,062 patients with atrial fibrillation.

Results: We identified three distinct phenotypes: non-white participants, mostly from Asia (A); white participants without previous use of vitamin-K antagonists (B); and white participants with previous use of vitamin-K antagonist (C). The effect of the higher-dose edoxaban regimen vs warfarin significantly varied over phenotypes (p for interaction = 0.03) with the strongest benefit in cluster A (HR = 0.72, 95 % CI: 0.52-1.00), moderate effect in cluster B (HR = 0.80, 95 % CI: 0.61, 1.06) and no observed effect in cluster C (HR = 1.01, 95 % CI: 0.80, 1.27).

Conclusions: Assessing HTE over patients' phenotypes might represent a relevant complement to other stratification approaches to elucidate results from subgroups analyses, especially in those settings where an overwhelming superiority overall effect was not observed. Cluster analysis allows a clear discrimination of patients with direct interpretability of who are the patients that would most benefit from the investigated strategy or treatment.