Stroke and CPAP Outcome Study 3 Randomized Controlled Trial
Optimizing Adherence to the Treatment of Sleep Apnea Among Patients With Stroke Undergoing Inpatient Rehabilitation
About This Trial
The SCOUTS 3 study aims to test the effectiveness of an intensive CPAP (Continuous Positive Airway Pressure) therapy support program compared to usual care in stroke patients with obstructive sleep apnea (OSA) during inpatient rehabilitation (IPR). The study is a multicenter randomized controlled trial (RCT) involving recruitment of about 250 participants across two institutions and randomization of about 200 participants. It compares an intensive support (IS) program for CPAP use with standard support (SS) to evaluate the effectiveness of the IS intervention in increasing CPAP usage during and after stroke rehabilitation. The Intensive Support (IS) group will receive a multicomponent intensive behavioral adherence program, which includes a CPAP technical support intervention, Motivational Enhancement Therapy (MET), and a Mobile Health intervention. Outcomes measured include CPAP adherence as measured by average nightly use in minutes between randomization and 3 months and the modified Rankin Scale (mRS-9Q) to evaluate stroke recovery.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
View original clinical language
Treatments Being Tested
CPAP device
Eligible participants with OSA will be started on automatically-adjusting CPAP.
CPAP technical support
Trained personnel will conduct mask selection and fitting, provide continual troubleshooting, and train participants on CPAP.
Phone follow-up for adherence feedback and self-management skills
The research coordinator will call participants approximately monthly to provide any needed support.
myAir
Study personnel will assist participants in registering for and using the myAir (ResMed) self-tracking app. This app also provides a library of how-to videos and provides email updates to participants.
Tailored messages
Tailored text messages will be sent to participants. Two-way texting messaging will also be available between the study team and participants.
Written Materials
A binder of written educational materials will be provided to participants.
Motivational Enhancement Therapy (MET)
A trained sleep coach will conduct up to 5 MET sessions with participants and 2 sessions with a CPAP partner during the study time period.