Motivational Enhancement - Acute Decompensated Heart Failure and OSA
NCT04752462 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2025-07-09
Summary
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.
Conditions
- Acute Decompensated Heart Failure
- Obstructive Sleep Apnea
- Motivational Enhancement
- PAP Adherence
Interventions
- BEHAVIORAL
-
Telemedicine Intensive Motivational Enhancement
Participants will attend a telemedicine motivational enhancement visit to improve PAP adherence along with regular follow up for sleep apnea
Sponsors & Collaborators
-
American Academy of Sleep Medicine
collaborator OTHER -
The Cleveland Clinic
lead OTHER
Principal Investigators
-
Cinthya Pena Orbea, MD · The Cleveland Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-13
- Primary Completion
- 2025-01-31
- Completion
- 2025-01-31
Countries
- United States
Study Locations
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