Health Coaching for Patients With Cardiovascular Disease

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Body weight [Срок оценки: Baseline (day of hospital discharge) and at provider appointment in the ambulatory setting, 16 weeks post-hospital discharge]
• Hospital readmissions [Срок оценки: Hospital readmissions during the 30-, 60-, and 90-days post-hospital discharge for cardiovascular disease, documented in the electronic medical record]
• MyChart messages [Срок оценки: Over the course of 16 weeks, from hospital discharge to 16 weeks post-hospital discharge]
• Perceived Stress [Срок оценки: Baseline (hospital discharge), 8 weeks post-hospital discharge, and 16 weeks post-hospital discharge]
• Medication Adherence [Срок оценки: Baseline, and at 8 weeks post-hospital discharge and at 16 weeks post-hospital discharge]
• Lifestyle Medicine Behavior Assessment [Срок оценки: Completed at baseline, at 8 weeks post-hospital discharge and at 16 weeks post-hospital discharge]
• Acceptability of Intervention Measure [Срок оценки: Completed after the 16 week health coaching intervention for participants in the intervention group.]

Вторичные конечные точки (4)

• Patient Qualitative Comments [Срок оценки: Immediately after completion of the 16 week health coaching intervention; i.e. 16 weeks post-hospital discharge]
• Provider Qualitative Comments [Срок оценки: Will be completed within one month of their patient completing the health coach intervention.]
• Patient Health Questionnaire (PHQ-9) [Срок оценки: Baseline, 4-, 8-, and 16 weeks post-discharge for all participants]
• Generalized Anxiety Disorder-7 (GAD-7) [Срок оценки: Baseline, 4-, 8-, and 16 weeks post-discharge for all participants]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• The Ohio State University Wexner Medical Center — Columbus

Идентификаторы

NCT: NCT06904144 · 2024H0179

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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