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Motivational Enhancement Therapy for Heart Failure and Sleep Apnea
N/A
Recruiting
Led By Cinthya Pena Orbea, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Admitting ADHF diagnosis
Treatment-naive and agreeable to PAP therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month
Awards & highlights
Study Summary
This trial will compare the effects of two different methods of care on patients with a new diagnosis of OSA who have been admitted to the hospital for ADHF. One group of patients will receive standard care, while the other group will receive early telemedicine care that includes motivational enhancement. The trial will follow patients for six months to assess the impact of the different methods of care on things like patient reported outcomes, hospital readmissions, and continuity of care.
Who is the study for?
This trial is for patients hospitalized with acute decompensated heart failure (ADHF) who are newly diagnosed with obstructive sleep apnea (OSA, REI ≥5), have not used PAP therapy before, and agree to use it. Excluded are those with central predominant apnea, unstable vital signs, dementia, prior PAP use, inability to consent or participate in video calls.Check my eligibility
What is being tested?
The study tests if a telemedicine program providing intensive motivational support (TIME) can improve adherence to positive airway pressure (PAP) therapy over standard care. It also looks at the effect on patient outcomes and hospital readmissions within 6 months after discharge.See study design
What are the potential side effects?
While this trial focuses on behavioral intervention rather than medication side effects may include discomfort from using PAP devices or potential stress from frequent telemedicine sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am diagnosed with acute decompensated heart failure.
Select...
I have not received any treatment and agree to start PAP therapy.
Select...
I have been diagnosed with obstructive sleep apnea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Functional Outcomes of Sleep Questionnaire (TIME versus Standard of Care)
Kansas City Cardiomyopathy Questionnaire (TIME versus Standard of Care)
PAP Adherence (TIME versus Standard of Care)
Other outcome measures
Impact of TIME vs Standard of Care on 6-month hospital readmissions
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Telemedicine Intensive Motivational EnhancementExperimental Treatment1 Intervention
Participants will attend a telemedicine motivational enhancement visit to improve PAP adherence along with regular follow up for sleep apnea
Group II: Standard of Care with providerActive Control1 Intervention
Participant will continue follow up for sleep apnea with provider.
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,029 Previous Clinical Trials
1,364,998 Total Patients Enrolled
American Academy of Sleep MedicineOTHER
22 Previous Clinical Trials
2,558 Total Patients Enrolled
Cinthya Pena Orbea, MDPrincipal Investigator - The Cleveland Clinic
The Cleveland Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received PAP therapy before or am currently on it.My oxygen levels drop below 87% without aid or I need more than 2L of O2 at night.I am diagnosed with acute decompensated heart failure.I have not received any treatment and agree to start PAP therapy.You have problems with memory and thinking.I have been diagnosed with obstructive sleep apnea.I am unable to understand and agree to the study's details on my own.I do not have low blood pressure (<90 mmHg) or a fast heart rate (>120 bpm).You have a type of breathing problem called central apnea where most of your breathing pauses are caused by problems in the brain signaling.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care with provider
- Group 2: Telemedicine Intensive Motivational Enhancement
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still open for this clinical research?
"Correct. According to clinicaltrials.gov, this medical trial is actively recruiting patients since it was first posted on May 13th 2021 and edited July 13th 2022. 80 individuals are sought from 1 specific site for participation in the study."
Answered by AI
What is the current enrollment rate for this clinical exploration?
"Affirmative. According to the information posted on clinicaltrials.gov, this study is currently seeking participants with recruitment commencing from May 13th 2021 and most recently updated in June 13th 2022. 80 patients are needed for the trial at one location."
Answered by AI
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