Motivational Enhancement - Acute Decompensated Heart Failure and OSA

July 3, 2025 updated by: Cinthya Pena Orbea, The Cleveland Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

As part of our inpatient sleep testing program, high-risk HF patients undergo Type III sleep testing (Nihon Kohden®) set up by sleep laboratory technicians. Our inpatient sleep service also has a clinical nurse who works with patients on CPAP education, set up and assists with post hospital sleep care. If a titration study is needed, it is generally arranged 1-2 weeks post discharge. All inpatient sleep studies are scored by three registered polysomnographic technologists and I review and finalize these studies (current clinical flow as the primary physician leading the inpatient service, which will be augmented for this clinical trial). A research coordinator and I will approach those with REI>5 who meet eligibility per screening in Epic®, to discuss sleep study results, confirm eligibility, invite the patient to participate, and if interested, will obtain written informed consent. Consent: Consent form will explain in a lay person' terminology the nature of all procedures. It will be stressed that participation is voluntary. The research coordinator and the PI will be available to answer questions. All activities will be compliant with local IRB and HIPPA guidelines.

All participants will obtain Auto-CPAP from two manufacturers (Philips Respironics ® or ResMed ®) delivered by the same homecare health before discharge. PAP pressures will be set at 5-15 cmH2O, heated humification, and expiratory pressure relief according to comfort. A modem will be attached to the PAP device to extract adherence data remotely (SD card for those without wireless capability). All patients will receive a standardized 20-minute educational session about PAP therapy before discharge and will be advised to use their device every night during sleep by our clinical nurse. Patients will also be fitted for a mask fitted homecare health. If participants have mask or pressure intolerance issues, they will be a direct provided a phone number to our research coordinator. All baseline questionnaires will be sent via REDcap link to the patient's e-mail or completed in paper form before discharge and during their visit (or paper if electronic not feasible). The coordinator will ensure all questionnaires are completed before discharge and will instruct patients to complete follow-up questionnaires. Patients will be randomized (REDCap algorithm) 1:1 to TIME versus standard of care. Blocks will be of random size blinded to study investigators. Although it will not be feasible to blind the research team and participants to the intervention, the standard of care group will also receive sleep hygiene education so that there is perception of some level of intervention to try to address placebo effect. During follow up visits (2 weeks and 2 months for the TIME group and 2 months standard of care group) with sleep medicine, the first 15 minutes will be focused on OSA and troubleshooting problems for both groups as this is standard clinical care provided at our Sleep Disorders Center. These 15 minutes will be followed by 30 minutes of ME in the intervention group and 10 minutes of sleep hygiene education in the control group. Outcomes will be measured at 3 months and 6 months for both groups. Both groups will receive a booster phone call at 4 months. The intervention group will receive a 30 minutes booster ME session and the control group will receive 10 minutes of sleep hygiene.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care with provider
Participant will continue follow up for sleep apnea with provider.
Experimental: Telemedicine Intensive Motivational Enhancement
Participants will attend a telemedicine motivational enhancement visit to improve PAP adherence along with regular follow up for sleep apnea
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
Other Names:
  • TIME

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PAP Adherence (TIME versus Standard of Care)
Time Frame: 3 Month
average hourly use per night
3 Month
PAP Adherence (TIME versus Standard of Care)
Time Frame: 6 Month
average hourly use per night
6 Month
Functional Outcomes of Sleep Questionnaire (TIME versus Standard of Care)
Time Frame: 2 Months
Functional Outcomes of Sleep Questionnaire (FOSQ-10): Subscale scores range from 1-4 (1= extreme difficulty, 2= moderate difficulty, 3= a little difficulty, 4= no difficulty) with total scores ranging from 5-20 with higher scores indicating better functional status.
2 Months
Kansas City Cardiomyopathy Questionnaire (TIME versus Standard of Care)
Time Frame: 2 Months
Kansas City Cardiomyopathy Questionnaire (KCCQ-12):: physical limitation, symptom frequency, quality of life, and social limitation. Scores ranges from 5-30, higher KCCQ-12 scores from baseline represent better health status
2 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of TIME vs Standard of Care on 6-month hospital readmissions
Time Frame: 6 Month
6-month hospital readmissions
6 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

American Academy of Sleep Medicine

Investigators

  • Principal Investigator: Cinthya Pena Orbea, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

May 13, 2021

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

February 9, 2021

First Posted (Actual)

February 12, 2021

Study Record Updates

Last Update Posted (Actual)

July 9, 2025

Last Update Submitted That Met QC Criteria

July 3, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-075

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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