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Motivational Enhancement - Acute Decompensated Heart Failure and OSA
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
🗓️ Study Start (Actual) 13 May 2021
🗓️ Primary Completion (Estimated) 31 December 2024
✅ Study Completion (Estimated) 31 December 2024
👥 Enrollment (Estimated) 80
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Cleveland, Ohio, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 February 2021
  • First Submitted that Met QC Criteria 9 February 2021
  • First Posted 12 February 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 April 2024
  • Last Update Posted 10 April 2024
  • Last Verified April 2024
I'm interested ...!!