Health Coaching for Patients with Cardiovascular Disease

Not Applicable

Not yet recruiting

• Conditions: Congestive Heart Failure Treated; Myocardial Infarction (MI); Coronary Artery Disease; Congestive Heart Failure Chronic

• Registration Number: NCT06904144
• Lead Sponsor: Ohio State University

Brief Summary

For patients discharged with a diagnosis of cardiovascular disease coronary artery disease resulting in myocardial infarction and/or congestive heart failure, this study will evaluate if the addition of 12 virtual health coaching sessions over the course of 16 weeks will improve physiological, psychological, and social health outcomes, prove acceptable and satisfactory for these patients with CVD, decrease CVD-related questions and concerns sent to the provider via MyChart, and reduce hospital readmission rates over a 90-day period as compared to patients discharged with the same diagnosis who receive standard post-discharge care. The study will also evaluate the perceptions of physician and advanced practice providers related to the health coach as part of the interprofessional team and the amount of time spent addressing CVD-related patient questions and concerns via MyChart messages.

Detailed Description

The purpose of this mixed methods study is to evaluate the impact of 12 virtual health coaching sessions, provided post-discharge, over the course of 16 weeks on: 1) patient physiological measure of weight; 2) patient-reported perceived stress and medication adherence, and physical, emotional, and social lifestyle behaviors; and 3) MyChart messaging to their providers related to concerns and/or questions about their cardiovascular diagnosis. The study will also assess: 4) patient acceptability and satisfaction with the health coaching intervention; 5) acceptability and satisfaction value and/or importance of the health coach intervention and feasibility of integrating the health coach into the inter-professional care team from the provider perspective; impact of the health coaching intervention on provider time spent on addressing MyChart messages; and 6) 30-, 60-, and 90-day hospital readmission rates.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-24
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-04-01
• Last Update Posted: 2025-04-01
• Study Start: 2025-08-01
• Primary Completion: 2027-02-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• 18 years of age or older
• diagnosis of coronary artery disease resulting in myocardial infarction and/or congestive heart failure
• physical condition effectively managed by routine healthcare and not requiring urgent medical attention
• ability to communicate in English
• access to a working phone or computer and ability to communicate via phone or computer.

Exclusion Criteria

• Documented cognitive and/or major psychiatric disorders, including dementia, and major depression or anxiety uncontrolled by anti-psychotic and/or anti- depressant medication, and/or admission to a psychiatric facility within the past three months
• current alcohol or drug dependency
• resident of extended care/skilled facility
• prisoners or ward of state.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acceptability of Intervention Measure	Completed after the 16 week health coaching intervention for participants in the intervention group.	The Acceptability of Intervention Measure (AIM) is a 4-item self-report assessment to evaluate the acceptability of the health coaching intervention. Each statement is scored with a 5-point Likert Scale that includes 1 (completely disagree), 2 (disagree), 3 (neither agree nor disagree), 4 (agree), and 5 (completely agree). Total scores ranges from 4-20 with higher total scores indicating higher acceptability.
Body weight	Baseline (day of hospital discharge) and at provider appointment in the ambulatory setting, 16 weeks post-hospital discharge	Patient body weight in kilograms will be obtained by clinical staff on hospital approved and calibrated electronic standing scales. The patient's body weight will be collected from the patient's electronic medical record.
Hospital readmissions	Hospital readmissions during the 30-, 60-, and 90-days post-hospital discharge for cardiovascular disease, documented in the electronic medical record	Hospital readmissions for an inpatient stay, documented in the electronic medical record, after the hospital post-discharge for cardiovascular disease
MyChart messages	Over the course of 16 weeks, from hospital discharge to 16 weeks post-hospital discharge	MyChart messages are questions or requests directed to the patient's provider that are related to the patient's cardiovascular disease diagnosis and hospitalization. These MyChart messages are entered into the electronic medical record by the patient and are directed to their provider, requiring an electronic or telephone response to the patient with a documented note entered by the provider relative to the follow-up provided to the patient. This outcome measure will be the number of MyChart messages entered by the patient and responded to by the provider.
Perceived Stress	Baseline (hospital discharge), 8 weeks post-hospital discharge, and 16 weeks post-hospital discharge	Perceived Stress Scale-10 (PSS-10). A 10-item self-report measure of perceived stress. It is a measure of the degree to which situations in one's life are appraised as stressful over the past month. The 4-point Likert Scale includes responses of 0 (never), 1 (almost never), 2 (sometimes), 3 (fairly often), and 4 (very often). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Medication Adherence	Baseline, and at 8 weeks post-hospital discharge and at 16 weeks post-hospital discharge	The Hill-Bone Medication Adherence Scale (MB-MAS) is a 9-item self-assessment of medication adherence relative to a variety of chronic diseases and conditions. Likert Scale responses to each of the nine statements include 1 (all of the time), 2 (most of the time), 3 (some of the time), and 4 (none of the time). Total scores range from 4 to 36 with higher scores indicating higher medication adherence.
Lifestyle Medicine Behavior Assessment	Completed at baseline, at 8 weeks post-hospital discharge and at 16 weeks post-hospital discharge	The Lifestyle Medicine Short Form is a 14-item self-assessment scale evaluating physical, emotional, social lifestyle behaviors. The assessment questions comprise core metrics that capture readiness to change, as well as health behaviors that are aligned with the six pillars of lifestyle medicine--physical activity, nutrition, sleep health, stress reduction, social connections, and risky substances. Questions have multiple responses based on information relating to the six pillars of lifestyle medicine. The first two questions related to Readiness to Change use a Likert Scale ranging from 0 (Not Ready) to 10 (Very Ready). Questions related to Motivation and Diet request that the participant denote different aspects of their diet. Physical exercise questions request specific days/times in minutes completed. Questions related to sleep request average hours of sleep per 24 hour period. Mood, connectedness with others, and substance use request types/amounts per week.

Secondary Outcome Measures

Name	Time	Method
Patient Qualitative Comments	Immediately after completion of the 16 week health coaching intervention; i.e. 16 weeks post-hospital discharge	Patient perceptions of the health coaching intervention will be solicited with the following question prompts: 1) Can you provide feedback about your health coaching experience?; 2) Did working with the health coach help you meet your health goals?; 3) Would you recommend working with a health coach to others?
Provider Qualitative Comments	Will be completed within one month of their patient completing the health coach intervention.	Provider perceptions of the value of the health coach as part of the interprofessional team and the feasibility of integrating the health coach into the patient's care will be solicited via question prompts that will include: 1) Can you discuss your perceptions about the value of the health coach as a member of the patient's care team; 2) Were you able to review the health coaches notes in the patient's medical record? (if yes) Were the notes helpful to you during the patient's follow-up appointment(s), i.e. in addressing the patient's condition, their post-discharge recovery, adherence to medical instructions, progress or lack of progress?; 3) Can you provide your perceptions of the feasibility of integrating the health coach as part of the patient's care team?

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States