Health Coaching for Patients With Cardiovascular Disease

Health Coaching for Patients With Cardiovascular Disease: A Mixed-Methods Evaluation of the Impact on Patient Outcomes and Provider Satisfaction and Acceptability

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Congestive Heart Failure Chronic; Myocardial Infarction (MI); Congestive Heart Failure Treated
• Intervention / Treatment: Behavioral: Health Coaching

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, anxiety, depression, 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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beth Steinberg, PhD, RN; Phone Number: 614-406-7067; Email: steinberg.35@osu.edu
• Study Contact Backup: Name: Maryanna Klatt, PhD; Phone Number: 614-293-3644; Email: Klatt.8@osu.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
      • Contact: Beth Steinberg, PhD, RN; Phone Number: 614-406-7067; Email: steinberg.35@osu.edu
      • Contact: Maryanna Klatt, PhD; Phone Number: 614-293-3644; Email: Klatt.8@osu.edu
      • Principal Investigator: Beth Steinberg, PhD, RN

Participation Criteria

Eligibility Criteria

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

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health Coaching Intervention Group; Participants will receive 12 health coaching sessions post-discharge over a 16 week period	Behavioral: Health Coaching; 12 virtual health coaching sessions will be provided over a 16 week period by a certified health coach.
No Intervention: Standard Care Group; Participants will receive usual post-discharge care over the 16 week period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Qualitative Comments	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?	Immediately after completion of the 16 week health coaching intervention; i.e. 16 weeks post-hospital discharge
Provider Qualitative Comments	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?	Will be completed within one month of their patient completing the health coach intervention.
Patient Health Questionnaire (PHQ-9)	A 9-item depression module the Patient Health Questionnaire that scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day); scores range from 9-27.	Baseline, 4-, 8-, and 16 weeks post-discharge for all participants
Generalized Anxiety Disorder-7 (GAD-7)	A 7-item screening tool assessing anxiety over the past 2 weeks. Questions are scored from "0" (not at all) to "3" (nearly every day). Scores range from 0-21.	Baseline, 4-, 8-, and 16 weeks post-discharge for all participants

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Beth Steinberg, PhD, RN, Ohio State University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: coronary artery disease; myocardial infarction; congestive heart failure; health coaching
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Heart Failure; Coronary Artery Disease; Myocardial Infarction
• Other Study ID Numbers: 2024H0179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD that will be shared will include de-identified descriptive data for both the intervention and control groups, including gender, race, educational level and mean age. Additionally, cardiovascular disease diagnoses, hospital readmissions at 30-, 60-, and 90- days post-hospital discharge, and number of MyChart messages sent by the patient to their provider. Acceptability of the intervention descriptive data for the intervention group will also be included. Differences in mean scores between the intervention and control groups for weight (significance and effect sizes), perceived stress and medication adherence will be shared. De-identified, curated qualitative data that will be shared includes interview transcripts from both patients and providers, as well as the qualitative codebooks and thematic analysis.
• IPD Sharing Time Frame: 12-30-2026 to indefinitely
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No