Telemedicine motivational support for heart failure and sleep apnea patients
Effect of Post-Discharge Telemedicine Motivational Enhancement Intervention in Heart Failure and Obstructive Sleep Apnea on Adherence and Health Outcomes
This study is testing if a special telemedicine support program can help people with heart failure and sleep apnea do better than just regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04752462 on ClinicalTrials.gov |
What this trial studies
This clinical trial examines the effectiveness of an early intensive telemedicine motivational enhancement program compared to standard care for patients with acute decompensated heart failure (ADHF) and newly diagnosed obstructive sleep apnea (OSA). Participants will receive Auto-CPAP therapy and will be monitored for adherence and patient-reported outcomes over a 6-month period. The study aims to assess the impact of this intervention on hospital readmissions and overall continuity of care. A total of 80 patients will be randomized into two groups to evaluate these outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients admitted with acute decompensated heart failure who have a new diagnosis of obstructive sleep apnea and are treatment-naive to PAP therapy.
Not a fit: Patients who have previously undergone PAP therapy or have significant cognitive dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve adherence to CPAP therapy and reduce hospital readmissions for patients with heart failure and sleep apnea.
How similar studies have performed: Other studies have shown promising results with telemedicine interventions for chronic conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Admitting ADHF diagnosis * OSA diagnosis (REI ≥5) * Treatment-naive and agreeable to PAP therapy * Agrees to participate. Exclusion Criteria: * Prior or current PAP therapy * Unable to provide informed consent * Moderately hypoxic (oxygen saturation \< 87% on room air or requiring \>2L of O2 during overnight sleep study * Hemodynamically unstable (systolic blood pressure, SBP\<90 mmHg, heart rate\>120bpm) * Central predominant apnea (Central Apnea Index \> 50% of the Apnea Index) Dementia/cognitive dysfunction * Unable to participant in video televisits.
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Cinthya Pena Orbea, MD — The Cleveland Clinic
- Study coordinator: Joan Aylor, BA
- Email: aylorj@ccf.org
- Phone: 216-445-1698
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.