Health Coaching for Patients With Cardiovascular Disease

NCT06904144 | Not Yet Recruiting

• 1 other identifier: 2024H0179
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

health coaching; coronary artery disease; congestive heart failure; myocardial infarction

Outcome Measures

Primary Outcomes (7)

• Body weight

  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.

  Baseline (day of hospital discharge) and at provider appointment in the ambulatory setting, 16 weeks post-hospital discharge

• Hospital readmissions

  Hospital readmissions for an inpatient stay, documented in the electronic medical record, after the hospital post-discharge for cardiovascular disease

  Hospital readmissions during the 30-, 60-, and 90-days post-hospital discharge for cardiovascular disease, documented in the electronic medical record

• MyChart messages

  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.

  Over the course of 16 weeks, from hospital discharge to 16 weeks post-hospital discharge

• Perceived Stress

  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.

  Baseline (hospital discharge), 8 weeks post-hospital discharge, and 16 weeks post-hospital discharge

• Medication Adherence

  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.

  Baseline, and at 8 weeks post-hospital discharge and at 16 weeks post-hospital discharge

• Lifestyle Medicine Behavior Assessment

  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.

  Completed at baseline, at 8 weeks post-hospital discharge and at 16 weeks post-hospital discharge

• Acceptability of Intervention Measure

  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.

  Completed after the 16 week health coaching intervention for participants in the intervention group.

Secondary Outcomes (4)

• Patient Qualitative Comments

  Immediately after completion of the 16 week health coaching intervention; i.e. 16 weeks post-hospital discharge

• Provider Qualitative Comments

  Will be completed within one month of their patient completing the health coach intervention.

• Patient Health Questionnaire (PHQ-9)

  Baseline, 4-, 8-, and 16 weeks post-discharge for all participants

• Generalized Anxiety Disorder-7 (GAD-7)

  Baseline, 4-, 8-, and 16 weeks post-discharge for all participants

Study Arms (2)

Health Coaching Intervention Group

EXPERIMENTAL

Participants will receive 12 health coaching sessions post-discharge over a 16 week period

Behavioral: Health Coaching

Standard Care Group

NO INTERVENTION

Participants will receive usual post-discharge care over the 16 week period

Interventions

Health Coaching BEHAVIORAL

12 virtual health coaching sessions will be provided over a 16 week period by a certified health coach.

Health Coaching Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who have had chest coronary artery bypass surgery
• Documented cognitive and/or major psychiatric disorders, including dementia, Alzheimer's, depression or anxiety uncontrolled by anxiolytic, anti-psychotic, and/or anti-depressants and/or PHQ-9 score 15-27 and GAD-7 score \>15
• current alcohol or drug dependency
• resident of extended care/skilled facility
• prisoners or ward of state.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Myocardial Infarction; Coronary Artery Disease; Heart Failure

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Beth Steinberg, PhD, RN

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beth Steinberg, PhD, RN

CONTACT

614-406-7067; steinberg.35@osu.edu

Maryanna Klatt, PhD

CONTACT

614-293-3644; klatt.8@osu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Research

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: April 1, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR, ANALYTIC CODE
• Time Frame: 12-30-2026 to indefinitely
• Access Criteria: De-identified and curated demographic, statistical data, study overview, study consent will be accessible to academic researchers and educators through a data accessibility link once the Qualitative Data Repository submission is finalized.

Locations

US (1)