Recruiting

Heart to Heart

Sponsor:

Johns Hopkins University

Code:

NCT06908590

Conditions

CVD - Cardiovascular Disease

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT06908590

Start date

Feb 19, 2026

Status verified date

Feb, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: H2H Intervention

Providing the H2H Intervention to Participants

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

Primary outcome measure

  • Feasibility of H2H intervention as assess by the ability to recruit ≥ 25% of those eligible and the ability to retain ≥ 50% in the study [ Time Frame: 3 months ]
  • Acceptability as measured by survey of participant satisfaction with H2H [ Time Frame: 3 months ]
  • Acceptability as measured by participant satisfaction (qualitative interview) [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Lena Mathews, MD

410-550-5191lmathew6@jhmi.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21217

Contacts

Lena Mathews, MD

917-270-8339lmathew6@jhmi.edu

Johns Hopkins Bayview Medical Center

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Lena M Mathews, MD MHS

410-550-5191lmathew6@jhmi.edu

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Lena M Mathews, MD MHS

410-550-5191lmathew6@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • cardiac rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-02-27.