Clinical trial NCT06908590: Community Health Worker-Led Intervention to Increase Cardiac Rehabilitation Participation
Official title: Heart-to-Heart: A Community Health Worker-Led Intervention to Increase Cardiac Rehabilitation Participation Among Patients With Low Socioeconomic Status
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: CVD - Cardiovascular Disease
Keywords: cardiac rehabilitation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-04-03
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
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
timeFrame: 3 months
measure: Acceptability as measured by survey of participant satisfaction with H2H
timeFrame: 3 months
measure: Acceptability as measured by participant satisfaction (qualitative interview)
timeFrame: 3 months
Secondary outcomes:
measure: Change in Cardiac rehab barriers scale
timeFrame: 3 months
measure: Change in Patient Activation Measure
timeFrame: 3 months
measure: Number of CR sessions attended
timeFrame: 3 and 6 months
Other outcomes:
measure: Number of CHW sessions contacts
timeFrame: 6 months
measure: Duration of CHW sessions contacts (minutes)
timeFrame: 6 months
measure: Number of CHW sessions contacts attempted
timeFrame: 6 months
measure: Number of CHW sessions contacts completed
timeFrame: 6 months
measure: Change in Health Related Quality of Life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale
timeFrame: 3 and 6 months
measure: Change in Depressive Symptoms as assessed by the Patient Health Questionnaire (PHQ)-8
timeFrame: 3 months
measure: Change in Anxiety Symptoms as assessed by the Generalized Anxiety Disorder (GAD7)
timeFrame: 3 months
measure: Change in Perceived Stress as assessed by the Perceived Stress Scale (PSS10)
timeFrame: 3 months
measure: Change in Physical Activity as assessed by the Telephone Assessment of Physical Activity (TAPA)
timeFrame: 3 and 6 months
measure: All-cause hospitalization
timeFrame: 6 months
measure: All-cause mortality
timeFrame: 6 months
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Lena Matthews, MD
role: PRINCIPAL_INVESTIGATOR
References: