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Implementing a Digitally-enabled Community Health Worker Intervention for Patients With Heart Failure

NCT05130008 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-04-20

Study results available
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Summary

The purpose of this study is to assess the acceptability, feasibility, and preliminary effectiveness of implementing a 30-day digitally-enabled community health worker intervention compared to usual care with a community health worker in reducing heart failure 30-day readmissions within a pilot randomized controlled trial.

Conditions

  • Heart Failure，Congestive

Interventions

OTHER

Digitally-enabled CHW Care

Patients will be paired with a CHW and be encouraged to wear the arm biosensor continuously, take blood pressure daily, respond to short symptom assessments daily or every other day, complete weekly life quality surveys, watch weekly HF educational videos and engage in digital (e.g., video visit) and phone-based, and in-person CHW interactions. Each participant will have access to the digital platform and CHW staff during their hospitalization and for the 30 days following discharge for a typical study duration of approximately 32-35 days. Participants will complete questionnaires at the time of enrollment and at study end. Participants will also complete exit interviews in-person or via phone after the study ends.

BEHAVIORAL

Usual CHW Care

Patients will be paired with a CHW for 30-days. Participants will complete questionnaires at the time of enrollment and at study end. Participants will also complete exit interviews in-person or via phone after the study ends.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Jocelyn Carter, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-23
Primary Completion
2023-06-01
Completion
2024-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05130008 on ClinicalTrials.gov