Clinical trial NCT06904144: Health Coaching for Patients With Cardiovascular Disease
Official title: Health Coaching for Patients With Cardiovascular Disease: A Mixed-Methods Evaluation of the Impact on Patient Outcomes and Provider Satisfaction and Acceptability
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body weight
timeFrame: Baseline (day of hospital discharge) and at provider appointment in the ambulatory setting, 16 weeks post-hospital discharge
measure: Hospital readmissions
timeFrame: Hospital readmissions during the 30-, 60-, and 90-days post-hospital discharge for cardiovascular disease, documented in the electronic medical record
measure: MyChart messages
timeFrame: Over the course of 16 weeks, from hospital discharge to 16 weeks post-hospital discharge
measure: Perceived Stress
timeFrame: Baseline (hospital discharge), 8 weeks post-hospital discharge, and 16 weeks post-hospital discharge
measure: Medication Adherence
timeFrame: Baseline, and at 8 weeks post-hospital discharge and at 16 weeks post-hospital discharge
measure: Lifestyle Medicine Behavior Assessment
timeFrame: Completed at baseline, at 8 weeks post-hospital discharge and at 16 weeks post-hospital discharge
measure: Acceptability of Intervention Measure
timeFrame: Completed after the 16 week health coaching intervention for participants in the intervention group.
Secondary outcomes:
measure: Patient Qualitative Comments
timeFrame: Immediately after completion of the 16 week health coaching intervention; i.e. 16 weeks post-hospital discharge
measure: Provider Qualitative Comments
timeFrame: Will be completed within one month of their patient completing the health coach intervention.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Beth Steinberg, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: