Motivational Enhancement - Acute Decompensated Heart Failure and OSA
NCT ID: NCT04752462
Last Updated: 2025-07-09
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
75 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-05-13
Study Completion Date
2025-01-31
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Acute Decompensated Heart Failure
Obstructive Sleep Apnea
Motivational Enhancement
PAP Adherence
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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Standard of Care with provider
Participant will continue follow up for sleep apnea with provider.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Telemedicine Intensive Motivational Enhancement
Participants will attend a telemedicine motivational enhancement visit to improve PAP adherence along with regular follow up for sleep apnea
Group Type
EXPERIMENTAL
Telemedicine Intensive Motivational Enhancement
Intervention Type
BEHAVIORAL
Participants will attend a telemedicine motivational enhancement visit to improve PAP adherence along with regular follow up for sleep apnea
Interventions
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Telemedicine Intensive Motivational Enhancement
Participants will attend a telemedicine motivational enhancement visit to improve PAP adherence along with regular follow up for sleep apnea
Intervention Type
BEHAVIORAL
Other Intervention Names
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TIME
Eligibility Criteria
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Inclusion Criteria
* Admitting ADHF diagnosis
* OSA diagnosis (REI ≥5)
* Treatment-naive and agreeable to PAP therapy
* Agrees to participate.
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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American Academy of Sleep Medicine
OTHER
Sponsor Role
collaborator
The Cleveland Clinic
OTHER
Sponsor Role
lead
Responsible Party
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Cinthya Pena Orbea
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Cinthya Pena Orbea, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic Foundation
Cleveland, Ohio, United States
Site Status
Countries
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United States
References
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Other Identifiers
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21-075
Identifier Type: -
Identifier Source: org_study_id
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