Contemporary clinical trials最新文献

Background: Research suggest that mind-body movement programs have beneficial effects on cognitive outcomes for older adults with cognitive decline. However, few studies have directly compared specific approaches to mind-body movement or studied the impact of remote program delivery.

Methods: In a 3-arm randomized controlled trial (RCT) for older adults with cognitive impairment, we are comparing a multidomain mind-body program that emphasizes movement, body awareness, personal meaningfulness, and social connection, and a traditional Chinese mind-body exercise (Tai Chi) to a health and wellness education control condition. All 3 interventions are delivered remotely two times per week (onehour per session) for 12 weeks. The two active interventions are live-streamed. Outcomes are assessed prior to, after, and 6-months after the interventions. The co-primary outcomes are changes on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) and brain functional connectivity in the Default Mode Network (DMN). Secondary outcomes include measures of specific cognitive domains (e.g., executive function, attention), mobility, and self-report measures of general well-being, quality of life, social engagement, self- and attention-regulation.

Conclusion: This RCT will directly compare the effects of two mind-body movement programs versus an education control delivered remotely over 12 weeks on cognitive, neuroimaging, and participant-reported outcomes. If successful, these programs may provide scalable strategies for slowing cognitive decline, which could potentially delay dementia onset in some individuals.

Trial registration id: NCT05217849.

Background: Fecal immunochemical testing (FIT) is a widely used first step for colorectal cancer (CRC) screening. Abnormal FIT results require a colonoscopy for screening completion and CRC diagnosis, but the rate of timely colonoscopy is low, especially among patients in safety-net settings. Multi-level factors at the clinic- and patient-levels influence colonoscopy completion after an abnormal FIT. Our study aims to implement a multi-level approach consisting of a clinic- and patient-level intervention to improve the completion of diagnostic colonoscopy after an abnormal FIT.

Methods: We will test a multilevel intervention with one safety-net system across 12 primary care clinics - a clinic-level intervention using a stepped wedge design and a patient-level intervention with patient-level randomization. At the clinic level, we will implement a "best practices bundle" to improve workflow for primary care providers and staff using a stepped-wedge design. At the patient level, we will randomize 2000 patients to receive text messages and call reminders or usual care.

Results: For the main analysis, we will use a mixed effects logistic model to assess the impact of the clinic intervention on the primary outcome (completion of colonoscopy within 180 days after abnormal FIT). Secondary outcomes include median days to colonoscopy completion, rate of referral to colonoscopy at 42 days, rate of scheduled colonoscopy at 56 days, and bowel preparation quality at colonoscopy.

Discussion: This study will assess the extent to which a multi-level intervention can improve timely colonoscopy completion in a diverse patient population cared for in a safety-net setting.

Trial registration: NCT, NCT06191185. Registered 20 December 2023, https://clinicaltrials.gov/study/NCT06191185.

The under-recruitment of historically marginalized populations into clinical trials thwarts equitable inclusion of individuals who could benefit from healthcare innovations and limits the generalizability of results. For decades, the Veterans Health Administration (VA) has conducted large clinical trials that impact clinical guidelines for veterans and civilians alike. Within the VA, women are a numeric minority, and recruitment of this population into trials is challenged by gender-specific care structures, distinct demographic characteristics, and mistreatment such as higher rates of military sexual trauma and harassment on VA grounds. We describe our approach to enhancing the inclusion of women veterans in clinical trials through the VA Women's Enhanced Recruitment Program (WERP) as developed for the VA Cooperative Studies Program. This information is relevant to clinical trial teams seeking to include women veterans in their trials. Our findings also have implications for other researchers seeking equitably increase participation of marginalized populations so that findings are generalizable to broader populations.

Background: Sexual exploitation of children and adolescents (SECA) is a mostly invisible phenomenon, having negative impacts on adolescents' health and well-being.. There is increasing awarenessof preventative strategies to reduce sexual exploitation of children and adolescents, but limited evidence on their effectiveness and mechanisms. This project addresses this gap through the impact and process evaluation of 'Growing Up Without Violence' (GWV), the largest intervention in Brazil tackling SECA.

Methods: We will conduct a two-arm cluster randomised trial (CRT) with parallel assignment in the municipalities of Cabo de Santo Agostinho and Jaboatão dos Guararapes, in Brazil. We will randomly allocate 30 schools to intervention and 30 to wait-list control arms. In each of these schools, we will randomly select independent samples of seventy students (aged 12 to 17) to participate in baseline and endline surveys. We will invite students to self-complete pre-programmed questionnaires in a private school space, under the supervision of trained researchers. Our main analysis is a cross-sectional comparison between control and intervention schools of students' levels of basic knowledge for identifying appropriate and inappropriate sexual advances and acts (primary outcome). Secondary outcomes include knowledge of risks of online sexual exploitation, willingness to report incidents of sexual abuse and exploitation, and recall of exposure SECA preventive training content.

Discussion: To our knowledge, this is the first large-scale rigorous evaluation of an intervention to prevent SECA in Brazil. Findings will inform our strategies and future interventions to prevent SECA.

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: 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: 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.