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Life sciences · Interventional Study
ClinicalTrials.gov · November 5, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT05091710). This is a study registration, not published results. Lead sponsor: Boston Medical Center. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 72 participants (ACTUAL). Conditions: Heart Failure. Interventions: OTHER: HF follow up care; OTHER: HF Standard of Care (SOC). Primary outcome measures: The Number of Participants Who Reported the HF Follow up Program by CHWs Was Acceptable , 90 days; The Number of Participants Who Reported That the HF Follow up Program Appropriate , 90 days; The Number of Participants Who Consent to Participate in the HF Follow up Program , 90 days; Completed Items in the Home Visit Checklist , 90 days; Number of Participants Who Completed a Scheduled Visit , 90 days; Number of Participants With All Home Visit Checklist Items Completed , 90 days. Brief summary: Evidence-based interventions to improve linkage and outcomes for heart failure (HF) patients requires input from stakeholders: patients, community health workers (CHWs), healthcare staff, and health system administrators. In this research the investigators will assess a CHW intervention designed to improve linkage to care for HF patients. This intervention was systematically adapted for use in rural Haiti in a prior study using the Assessment, Decisions, Administration, Production, Topical Experts, Integration, Training staff, Testing (ADAPT-ITT) framework. The ADAPT-ITT framework provides 8 sequential phases to adapt interventions and programs to new target audiences. It has been applied successfully to the adaptation of several interventions for HIV among under-resourced communities leading to randomized clinical trials. With the first 6 steps of the ADAPT-ITT framework completed in a prior study, this protocol outlines the training and testing of the adapted CHW intervention. In addition to assessing the feasibility, appropriateness, and acceptability of the adapted intervention through participants' feedback, the investigators will assess its efficacy in improving HF outcomes. The proposed intervention is targeted at both the patient domain - through improved peer support - and health system domain - by improving health system navigation.