CVD - Cardiovascular DiseaseH2HNCT06908590
Community Health Worker-Led Intervention to Increase Cardiac Rehabilitation Participation
A study testing Education, Providing and Engaging Social Support and Assistance with Health System Navigation in people with CVD - Cardiovascular Disease, run by Johns Hopkins University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- CVD - Cardiovascular Disease
- What is being tested?
- Education, Providing and Engaging Social Support and Assistance with Health System Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Feb 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21217
Lena Mathews, MD, 917-270-8339, lmathew6@jhmi.edu
- Recruiting
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Lena M Mathews, MD MHS, 410-550-5191, lmathew6@jhmi.edu
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21224
Lena M Mathews, MD MHS, 410-550-5191, lmathew6@jhmi.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- CVD - Cardiovascular Disease
- Being tested
- Education, Providing and Engaging Social Support and Assistance with Health System Navigation
- Keywords
- cardiac rehabilitation
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education, Providing and Engaging Social Support and Assistance with Health System NavigationBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| H2H Intervention | Experimental | Providing the H2H Intervention to Participants Receives: Behavioral: Education, Providing and Engaging Social Support and Assistance with Health System Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 3 months
Secondary outcomes (3)
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.
Measured: 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
Measured: 3 months
Number of CR sessions attended
(Preliminary Efficacy) Total number of CR sessions attended. This can range from 0 to 36.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start19 Feb 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CVD - Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Lena Matthews, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908590
- Sponsor's protocol ID
- IRB00463207
- Other IDs
- 1K23HL161404
- Acronym
- H2H
- Status last verified
- Feb 2026
- First submitted
- 27 Mar 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart-to-Heart: A Community Health Worker-Led Intervention to Increase Cardiac Rehabilitation Participation Among Patients With Low Socioeconomic Status
- ClinicalTrials.gov ID
- NCT06908590
- Acronym / sponsor ID
- H2H / IRB00463207
- Conditions
- CVD - Cardiovascular Disease
- Keywords
- cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H2H Intervention | Experimental | Behavioral: Education, Providing and Engaging Social Support and Assistance with Health System NavigationProviding the H2H Intervention to Participants |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education, Providing and Engaging Social Support and Assistance with Health System Navigation1. 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 | Behavioural | H2H Intervention |
Primary outcome
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
Proportion enrolled in the H2H among those eligible and approached, and Proportion who complete 4 H2H sessions or enroll in CR
Acceptability as measured by survey of participant satisfaction with H2H
Time frame: 3 months
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.
Acceptability as measured by participant satisfaction (qualitative interview)
Time frame: 3 months
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 secondary outcomes
Change in Cardiac rehab barriers scale
Time frame: 3 months
Change in Patient Activation Measure
Time frame: 3 months
Number of CR sessions attended
Time frame: 3 and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lena Matthews, MD principal investigator
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education, Providing and Engaging Social Support and Assistance with Health System Navigation in people with CVD - Cardiovascular Disease, run by Johns Hopkins University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lena Mathews, MD (410-550-5191, lmathew6@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.