COMPLETED

Motivational Enhancement - Acute Decompensated Heart Failure and OSA

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effect of Post-Discharge Telemedicine Motivational Enhancement Intervention in Heart Failure and Obstructive Sleep Apnea on Adherence and Health Outcomes

Quick Facts

Study Start:2021-05-13
Study Completion:2025-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04752462

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Admitting ADHF diagnosis
  2. * OSA diagnosis (REI ≥5)
  3. * Treatment-naive and agreeable to PAP therapy
  4. * Agrees to participate.
  1. * Prior or current PAP therapy
  2. * Unable to provide informed consent
  3. * Moderately hypoxic (oxygen saturation \< 87% on room air or requiring \>2L of O2 during overnight sleep study
  4. * Hemodynamically unstable (systolic blood pressure, SBP\<90 mmHg, heart rate\>120bpm)
  5. * Central predominant apnea (Central Apnea Index \> 50% of the Apnea Index) Dementia/cognitive dysfunction
  6. * Unable to participant in video televisits.

Contacts and Locations

Principal Investigator

Cinthya Pena Orbea, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

  • Cinthya Pena Orbea, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

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

Study Start Date2021-05-13
Study Completion Date2025-01-31

Study Record Updates

Study Start Date2021-05-13
Study Completion Date2025-01-31

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Decompensated Heart Failure
  • Obstructive Sleep Apnea
  • Motivational Enhancement
  • PAP Adherence