Community Health Worker-Led Intervention to Increase Cardiac Rehabilitation Participation

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

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

Вторичные конечные точки (3)

• Change in Cardiac rehab barriers scale [Срок оценки: 3 months]
• Change in Patient Activation Measure [Срок оценки: 3 months]
• Number of CR sessions attended [Срок оценки: 3 and 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 3 центра

• Johns Hopkins Hospital — Baltimore
• Johns Hopkins Bayview Medical Center — Baltimore
• Johns Hopkins Hospital — Baltimore

Идентификаторы

NCT: NCT06908590 · IRB00463207 · 1K23HL161404

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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