Community Health Worker-Led Intervention to Increase Cardiac Rehabilitation Participation

NCT06908590 | Recruiting

• 2 other identifiers: IRB004632071K23HL161404
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

CVD - Cardiovascular Disease

Keywords

cardiac rehabilitation

Outcome Measures

Primary Outcomes (3)

• Feasibility of H2H intervention as assess by the ability to recruit ≥ 25% of those eligible and the ability to retain ≥ 50% in the study

  Proportion enrolled in the H2H among those eligible and approached, and Proportion who complete 4 H2H sessions or enroll in CR

  3 months

• Acceptability as measured by survey of participant satisfaction with H2H

  Questionnaire: Scores on questionnaire to assess satisfaction. Questions are rated on a Likert scale from 1 (not at all) 5 extremely. There are 6 questions in the rating of the overall program with a total score range 6-30. Acceptability cutoff will be proportion of participants with score ≥ 18. There are 4 questions on the H2H coaching sessions and CHW. The maximum and minimum scores are 4 and 20 respectively. Acceptability cutoff will be proportion of participants with scores ≥ 12.

  3 months

• Acceptability as measured by participant satisfaction (qualitative interview)

  A semi-structured interview will be conducted by the research team about the H2H Program overall, and about the coaching sessions with the CHW, to determine the participants' perceptions of the degree to which the intervention was engaging, feasible, acceptable and useful. Recommendations for improving the H2H Program will be solicited. The interviews will take approximately 30-45 minutes. The interviews will be transcribed and analyzed for themes and codes

  3 months

Secondary Outcomes (3)

• Change in Cardiac rehab barriers scale

  3 months

• Change in Patient Activation Measure

  3 months

• Number of CR sessions attended

  3 and 6 months

Other Outcomes (11)

• Number of CHW sessions contacts

  6 months

• Duration of CHW sessions contacts (minutes)

  6 months

• Number of CHW sessions contacts attempted

  6 months

Study Arms (1)

H2H Intervention

EXPERIMENTAL

Providing the H2H Intervention to Participants

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

Interventions

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

H2H Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .
• Low socioeconomic status defined by Medicaid insurance, or top quartile of the area deprivation index in Baltimore city.
• Age ≥ 21 years
• Willing to be audio-recorded

You may not qualify if:

• Formal diagnosis of dementia or cognitive impairment in the Electronic Health Record (EHR) that would prohibit completion of study activities
• 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).
• Systemic illness limiting longevity (e.g., advanced cancer)
• Contraindications to CR as assessed by their health care team
• Unwilling or unable to follow study procedures.
• Unable to consent
• Unable to speak or understand English. Assessments including in-depth interviews will be conducted in English.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

Johns Hopkins Hospital

Baltimore, Maryland, 21217, United States

RECRUITING

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Educational Status; Insemination, Artificial, Heterologous

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Lena Matthews, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lena Mathews, MD

CONTACT

410-550-5191; lmathew6@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: February 19, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (3)