NCT04752462Completed
Motivational Enhancement - Acute Decompensated Heart Failure and OSA
Effect of Post-Discharge Telemedicine Motivational Enhancement Intervention in Heart Failure and Obstructive Sleep Apnea on Adherence and Health Outcomes
Source: ClinicalTrials.gov · Last updated 9 Jul 2025
Brief summary (registry, in English)
A feasibility randomized controlled trial will be conducted with a 6-month follow up to: Examine the impact of early intensive telemedicine motivational enhancement (TIME) vs standard of care on PAP adherence (n=40/group) and continuity of care at 3 and 6 months post-discharge in patients admitted with ADHF with a new inpatient diagnosis of OSA(REI\>5). Assess the effect of early telemedicine integrated with motivational enhancement (TIME) vs standard of care on patient reported outcomes including Functional Outcomes of Sleep questionnaire (FOSQ-10), Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Investigate the impact of early TIME vs standard of care on 6-month hospital readmissions.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 75 (actual)
- First submitted
- 9 Feb 2021
- Start date
- 13 May 2021
- Primary completion date
- 31 Jan 2025
- Lead sponsor
- The Cleveland Clinic
- Diseases
- Heart failure
- NCT number
- NCT04752462
What you commit to
- Study type: Interventional
- Participants enrolled: 75
- From 13 May 2021 to the primary completion date, 31 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or current PAP therapy
Other illness
- 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
Other
- Unable to provide informed consent
- Moderately hypoxic (oxygen saturation \< 87% on room air or requiring \>2L of O2 during overnight sleep study
- Unable to participant in video televisits.
Who the study is looking for
- Admitting ADHF diagnosis
- OSA diagnosis (REI ≥5)
- Treatment-naive and agreeable to PAP therapy
- Agrees to participate.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.