Clinical trial NCT04752462: Motivational Enhancement - Acute Decompensated Heart Failure and OSA
Official title: Effect of Post-Discharge Telemedicine Motivational Enhancement Intervention in Heart Failure and Obstructive Sleep Apnea on Adherence and Health Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Decompensated Heart Failure
Obstructive Sleep Apnea
Motivational Enhancement
PAP Adherence
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: American Academy of Sleep Medicine
First posted: 2021-02-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PAP Adherence (TIME versus Standard of Care)
timeFrame: 3 Month
measure: PAP Adherence (TIME versus Standard of Care)
timeFrame: 6 Month
measure: Functional Outcomes of Sleep Questionnaire (TIME versus Standard of Care)
timeFrame: 2 Months
measure: Kansas City Cardiomyopathy Questionnaire (TIME versus Standard of Care)
timeFrame: 2 Months
Secondary outcomes:
Other outcomes:
measure: Impact of TIME vs Standard of Care on 6-month hospital readmissions
timeFrame: 6 Month
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Cinthya Pena Orbea, MD
role: PRINCIPAL_INVESTIGATOR
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