Health Coaching for Patients With Cardiovascular Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Health Coaching

    Behavioral

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

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Health Coaching Intervention GroupExperimental treatment 1 intervention
Group B: Standard Care GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (day of hospital discharge) and at provider appointment in the ambulatory setting, 16 weeks post-hospital discharge
2

Hospital readmissions

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

Time frame
Hospital readmissions during the 30-, 60-, and 90-days post-hospital discharge for cardiovascular disease, documented in the electronic medical record
3

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.

Time frame
Over the course of 16 weeks, from hospital discharge to 16 weeks post-hospital discharge
4

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.

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

Secondary outcomes

1

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?

Time frame
Immediately after completion of the 16 week health coaching intervention; i.e. 16 weeks post-hospital discharge
2

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?

Time frame
Will be completed within one month of their patient completing the health coach intervention.
3

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.

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

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.

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

Other outcomes

Sponsors and contacts

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