Community Health Worker-Led Intervention to Increase Cardiac Rehabilitation Participation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: H2H InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
3 months
2

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.

Time frame
3 months
3

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

Time frame
3 months

Secondary outcomes

1

Change in Cardiac rehab barriers scale

Change in Cardiac Rehab Barriers Scale: 21-item questionnaire that assesses participants perceptions of barriers to CR. Each item is rated on a 5-point Likert Scale, with 1 indicating strong disagreement and 5 indicating strong agreement. This is a validated scale. Score range 21- 105. Higher scores indicate greater barriers to patient enrollment or participation in a CR program.

Time frame
3 months
2

Change in Patient Activation Measure

13-item questionnaire that assess participant's knowledge, skills, and confidence in managing their own health and healthcare. It is a validated patient related outcome measure. Each item rated on 4-point scale (1 strongly disagree to 4 strongly agree, with additional "not applicable" option). Score range is 13-52. Then, this score is transformed to a scale with a theoretical range 0-100, based on calibration tables, with higher Patient activation measure 13 (PAM13) scores indicating higher patient activation

Time frame
3 months
3

Number of CR sessions attended

(Preliminary Efficacy) Total number of CR sessions attended. This can range from 0 to 36.

Time frame
3 and 6 months

Other outcomes

1

Number of CHW sessions contacts

(Process Measures of Content Delivery) Number of CHW sessions contacts, where content is delivered, extra contacts, numbers of contacts attempted, number of contacts completed

Time frame
6 months
2

Duration of CHW sessions contacts (minutes)

(Process Measures of Content Delivery) Duration of coaching session

Time frame
6 months
3

Number of CHW sessions contacts attempted

(Process Measures of Content Delivery) Number of CHW sessions contacts attempted

Time frame
6 months
4

Number of CHW sessions contacts completed

(Process Measures of Content Delivery) Number of CHW sessions contacts completed

Time frame
6 months

Sponsors and contacts

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Johns Hopkins University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator