NCT06904144
Health Coaching for Patients With Cardiovascular Disease
StatusNot Yet Recruiting
PhaseNot applicable
SponsorOhio State University
Primary completion (estimated)
At risk: Primary completion moved at least 5 months later.
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Record History
All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗
Notable Primary completion pushed from Jul 1, 2027 to Dec 31, 2027 Show 4 more changesShow less
- Start date: Oct 1, 2026 to Jan 1, 2027
- Eligibility criteria expanded, about 10 words
- Study completion pushed from Oct 1, 2028 to Dec 31, 2028
- Secondary endpoints: details revised at 3 of 4 entries
- Notable Start date: Apr 1, 2026 to Oct 1, 2026
- Study completion pushed from Oct 1, 2027 to Oct 1, 2028
Notable Start date: Aug 1, 2025 to Apr 1, 2026v2 Show 6 more changesShow less
- Eligibility criteria expanded, about 4 words
- Enrollment target: 72 to 70
- Primary completion date: Feb 1, 2027 to Jul 1, 2027
- Study completion date: Aug 1, 2027 to Oct 1, 2027
- Secondary endpoints: 2 to 4
- Study description expanded, about 2 words
- Study First Submitted
- Notable: the plan changed
Endpoints
Primary
Body weight
Timeframe: Baseline (day of hospital discharge) and at provider appointment in the ambulatory setting, 16 weeks post-hospital discharge
Hospital readmissions
Timeframe: Hospital readmissions during the 30-, 60-, and 90-days post-hospital discharge for cardiovascular disease, documented in the electronic medical record
MyChart messages
Timeframe: Over the course of 16 weeks, from hospital discharge to 16 weeks post-hospital discharge
Perceived Stress
Timeframe: Baseline (hospital discharge), 8 weeks post-hospital discharge, and 16 weeks post-hospital discharge
Medication Adherence
Timeframe: Baseline, and at 8 weeks post-hospital discharge and at 16 weeks post-hospital discharge
Lifestyle Medicine Behavior Assessment
Timeframe: Completed at baseline, at 8 weeks post-hospital discharge and at 16 weeks post-hospital discharge
Acceptability of Intervention Measure
Timeframe: Completed after the 16 week health coaching intervention for participants in the intervention group.
Secondary (4)
Patient Qualitative Comments
Provider Qualitative Comments
Patient Health Questionnaire (PHQ-9)
Generalized Anxiety Disorder-7 (GAD-7)
Arms and interventions
Health Coaching Intervention GroupExperimental
Participants will receive 12 health coaching sessions post-discharge over a 16 week period
Standard Care GroupNo intervention
Participants will receive usual post-discharge care over the 16 week period
Behavioral: Health Coaching
Sites
1 site in 1 country
- The Ohio State University Wexner Medical CenterColumbus, Ohio, United States