Community Health Worker-Led Intervention to Increase Cardiac Rehabilitation Participation

NCT ID: NCT06908590

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-08
• Study Completion Date: 2027-07-01

Brief Summary

This study is being done to evaluate whether a program called Heart to Heart, that helps patients make a more informed decision about cardiac rehab (CR), is interesting, acceptable to participants, and whether participants would recommend it to others.

Detailed Description

This is a prospective, single-institution pilot study to evaluate the acceptability, feasibility and preliminary efficacy of a tailored Community Health Worker (CHW) led intervention to increase CR participation called H2H. Individuals hospitalized with Cardio Vascular Disease (CVD) events (aged 21 and older) will be identified and screened for eligibility from two Johns Hopkins acute care sites into the pilot study. The duration of participation for each participant is up to 6 months from baseline assessments.

All participants will complete a survey at baseline, 3-, and 6-months and will have medical record abstraction conducted performed by the Johns Hopkins (JH) research study team.

For the intervention, participants enrolled in the H2H program will complete between 4 to 8 coaching sessions with the CHW (delivered by telephone and/or video chat) who will provide tailored education, improve or engage the participant's existing social support network, and assistance with health system navigation over a 3-month period.

Conditions

CVD - Cardiovascular Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

H2H Intervention

Providing the H2H Intervention to Participants

Group Type: EXPERIMENTAL

Education, Providing and Engaging Social Support and Assistance with Health System Navigation

Intervention Type: BEHAVIORAL

1. Introduction to Program and Cardiac Rehab Needs Assessment Education about Cardiac Rehab

2. Education about CVD and how Cardiac Rehab can help in the participants recovery

3. Social Support Module

4. Health System Navigation Module

Interventions

Education, Providing and Engaging Social Support and Assistance with Health System Navigation

1. Introduction to Program and Cardiac Rehab Needs Assessment Education about Cardiac Rehab

2. Education about CVD and how Cardiac Rehab can help in the participants recovery

3. Social Support Module

4. Health System Navigation Module

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Patients hospitalized with cardiac events and eligible for CR at Johns Hopkins Hospital and Bayview Medical Center. CR eligibility is determined by their treating health care team .

2. Low socioeconomic status defined by Medicaid insurance, or top quartile of the area deprivation index in Baltimore city.

3. Age ≥ 21 years

4. Willing to be audio-recorded

Exclusion Criteria

1. Formal diagnosis of dementia or cognitive impairment in the Electronic Health Record (EHR) that would prohibit completion of study activities

2. Formal diagnosis of a severe psychiatric disorders by Diagnostic and Statistical Manual (DSM-5) criteria in the EHR that would prohibit completion of study activities (e.g., schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder).

3. Systemic illness limiting longevity (e.g., advanced cancer)

4. Contraindications to CR as assessed by their health care team

5. Unwilling or unable to follow study procedures.

6. Unable to consent

7. Unable to speak or understand English. Assessments including in-depth interviews will be conducted in English.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lena Matthews, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Central Contacts

Lena Mathews, MD

Role: CONTACT

lmathew6@jhmi.edu

410-550-5191

Facility Contacts

Lena M Mathews, MD MHS

Role: primary

lmathew6@jhmi.edu

410-550-5191

Lena M Mathews, MD MHS

Role: primary

lmathew6@jhmi.edu

410-550-5191

Other Identifiers

1K23HL161404

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00463207

Identifier Type: -

Identifier Source: org_study_id