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Not yet recruiting NCT06904144

Health Coaching for Patients With Cardiovascular Disease

No phase Interventional Congestive Heart Failure Treated Myocardial Infarction (MI) Coronary Artery Disease Congestive Heart Failure Chronic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Health Coaching.
Who it may be relevant to
Registry conditions: Congestive Heart Failure Treated, Myocardial Infarction (MI), Coronary Artery Disease, Congestive Heart Failure Chronic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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, 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.

Interventions

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

Primary outcome measures

  • Body weight [Time frame: Baseline (day of hospital discharge) and at provider appointment in the ambulatory setting, 16 weeks post-hospital discharge]
  • Hospital readmissions [Time frame: Hospital readmissions during the 30-, 60-, and 90-days post-hospital discharge for cardiovascular disease, documented in the electronic medical record]
  • MyChart messages [Time frame: Over the course of 16 weeks, from hospital discharge to 16 weeks post-hospital discharge]
  • Perceived Stress [Time frame: Baseline (hospital discharge), 8 weeks post-hospital discharge, and 16 weeks post-hospital discharge]
  • Medication Adherence [Time frame: Baseline, and at 8 weeks post-hospital discharge and at 16 weeks post-hospital discharge]
  • Lifestyle Medicine Behavior Assessment [Time frame: Completed at baseline, at 8 weeks post-hospital discharge and at 16 weeks post-hospital discharge]
  • Acceptability of Intervention Measure [Time frame: Completed after the 16 week health coaching intervention for participants in the intervention group.]
Secondary outcome measures (4)
  • Patient Qualitative Comments [Time frame: Immediately after completion of the 16 week health coaching intervention; i.e. 16 weeks post-hospital discharge]
  • Provider Qualitative Comments [Time frame: Will be completed within one month of their patient completing the health coach intervention.]
  • Patient Health Questionnaire (PHQ-9) [Time frame: Baseline, 4-, 8-, and 16 weeks post-discharge for all participants]
  • Generalized Anxiety Disorder-7 (GAD-7) [Time frame: Baseline, 4-, 8-, and 16 weeks post-discharge for all participants]

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

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • The Ohio State University Wexner Medical Center — Columbus

Identifiers

NCT: NCT06904144 · 2024H0179

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗