Community Health Worker-Led Intervention to Increase Cardiac Rehabilitation Participation (H2H)

Heart-to-Heart: A Community Health Worker-Led Intervention to Increase Cardiac Rehabilitation Participation Among Patients With Low Socioeconomic Status

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.

Study Overview

• Status: Recruiting
• Conditions: CVD - Cardiovascular Disease
• Intervention / Treatment: Behavioral: Education, Providing and Engaging Social Support and Assistance with Health System Navigation

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lena Mathews, MD; Phone Number: 410-550-5191; Email: lmathew6@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Johns Hopkins Bayview Medical Center
      • Contact: Lena M Mathews, MD MHS; Phone Number: 410-550-5191; Email: lmathew6@jhmi.edu
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Johns Hopkins Hospital
      • Contact: Lena M Mathews, MD MHS; Phone Number: 410-550-5191; Email: lmathew6@jhmi.edu
    • Baltimore, Maryland, United States, 21217
      • Recruiting
      • Johns Hopkins Hospital
      • Contact: Lena Mathews, MD; Phone Number: 917-270-8339; Email: lmathew6@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: H2H Intervention; Providing the H2H Intervention to Participants	Behavioral: Education, Providing and Engaging Social Support and Assistance with Health System Navigation; Introduction to Program and Cardiac Rehab Needs Assessment Education about Cardiac Rehab; Education about CVD and how Cardiac Rehab can help in the participants recovery; Social Support Module; Health System Navigation Module

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months
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	3 months
Number of CR sessions attended	(Preliminary Efficacy) Total number of CR sessions attended. This can range from 0 to 36.	3 and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
Duration of CHW sessions contacts (minutes)	(Process Measures of Content Delivery) Duration of coaching session	6 months
Number of CHW sessions contacts attempted	(Process Measures of Content Delivery) Number of CHW sessions contacts attempted	6 months
Number of CHW sessions contacts completed	(Process Measures of Content Delivery) Number of CHW sessions contacts completed	6 months
Change in Health Related Quality of Life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale	Change in mean score on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale PROMIS is a 10-item questionnaire that measures a person's global physical and mental health. This is a validated scale. Uses a 5-point Likert scale for most items, with a pain intensity item scored on a 0-10 scale (then recoded to a 5-point scale), to assess physical, mental, and social health, producing Global Mental and Physical Health scores. The score range for the PROMIS Global Health scales is 0- 100. Higher scores are better.	3 and 6 months
Change in Depressive Symptoms as assessed by the Patient Health Questionnaire (PHQ)-8	Change in mean score on the Patient Health Questionnaire (PHQ)-8 8-item scale that measures depressive symptoms over the past two weeks. Each of the eight items on the PHQ-8 is scored on a scale of 0 to 3, with 0 representing "not at all" and 3 representing "nearly every day" The total score is calculated by adding up the scores from each of the eight items, resulting in a possible score range of 0 to 24 A score of 5-9 indicates mild depressive symptoms, 10-14 moderate, 15-19 moderately severe, and 20-24 severe.	3 months
Change in Anxiety Symptoms as assessed by the Generalized Anxiety Disorder (GAD7)	Change in mean score on the Generalized Anxiety Disorder (GAD7) GAD7 is a 7-item scale those measures anxiety symptoms over the past few days, from not at all to nearly every day. Each of the 7 items is scored from 0 to 3, with higher scores indicating greater severity of anxiety symptoms A score of 5-9 indicates mild anxiety, 10-14 moderate, 15-19 moderately severe, and 20-21 severe anxiety The Generalized Anxiety Disorder-7 (GAD-7) scale has a maximum score range of 0- 21.	3 months
Change in Perceived Stress as assessed by the Perceived Stress Scale (PSS10)	Change in mean score on the Perceived Stress Scale (PSS10). PSS-10: The PSS-10 is a 10-item questionnaire where each item is scored on a 5-point Likert scale (0 = never, 4 = very often). The score range on the Perceived Stress Scale (PSS) is 0-40, with higher scores indicating greater perceived stress.	3 months
Change in Physical Activity as assessed by the Telephone Assessment of Physical Activity (TAPA)	Change in total score on the Telephone Assessment of Physical Activity (TAPA) 9-item questionnaire that asks the frequency, intensity, and duration of physical activity. This is a validated scale. Each question has a 'Yes' or 'No' option. The total score of the first seven items is out of 7; participants choose which question corresponds to their activity level. Any score less than 6 is considered suboptimal. Strength training and flexibility are scored separately (strength training = 1, flexibility = 2, both = 3)	3 and 6 months
All-cause hospitalization	Hospitalization	6 months
All-cause mortality	Mortality	6 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Lena Matthews, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: cardiac rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Investigative Techniques; Therapeutics; Socioeconomic Factors; Population Characteristics; Reproductive Techniques, Assisted; Reproductive Techniques; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Insemination, Artificial; Insemination; Educational Status; Insemination, Artificial, Heterologous
• Other Study ID Numbers: IRB00463207; 1K23HL161404 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No