This is a prospective, randomized, open-label study to evaluate effectiveness of applying financial and social incentives via a smartphone-based app in helping participants achieve adherence to PAP therapy.
This is a prospective, randomized, two-arm, open-label study to evaluate effectiveness of applying financial and social incentives via a smartphone-based app in helping participants achieve adherence to therapy. Randomization will include an allocation ratio of 2:1 (control:treatment). Participants will be recruited based on evidence that they are struggling to achieve adherence to therapy after the first 3 nights of usage. Two 'site to participant' contacts are required during this study. These contacts can either occur at the clinical site or remotely (e.g., by telephone). During the initial contact, their interest in the study and eligibility will be confirmed, then they will be consented, asked to complete the Baseline Questionnaire, and their demographic information will be collected on case report forms (CRFs). Participants randomized to the intervention (Group B) will be provided with information and assistance in downloading Restful to their smartphone and registering with Wellth. At the final contact (90 days), the participant will be asked to complete an End of Study Questionnaire and the investigative staff will collect PAP therapy data for the trial period and record it on CRFs. Participants in Group B will have access to the Restful app discontinued. This completes the participant's active participation in the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
166
The intervention is the use of Restful, the Wellth self-management app. There is no clinical treatment intervention, as all participants will be receiving PAP therapy per standard of care. Restful is a smartphone-based patient engagement tool that utilizes concepts from behavioral economics to help patients improve their adherence to therapy. The intervention includes a financial and social incentive reward program.
Sleep Data
San Diego, California, United States
Mean PAP Usage at 90 Days
Average nightly CPAP use for the 90 day time frame.
Time frame: 90 days
% of Participants That Meet Medicare Compliance Standard
Medicare compliance standard is using the PAP therapy for at least 4 hours per day on at least 70% of the days in a consecutive 30-day period any time in the first 90 days of therapy. Those that meet this standard are counted in the results below and divided by all patients.
Time frame: 90 days
Change in ESS Questionnaire Scores
Epworth Sleepiness Scale (ESS) will be administered at baseline and 90 days. The unit for this outcome is points. The total score can range from 0 to 24. A larger change or change that decreases from baseline will represent a better outcome. A smaller change or change that increases from baseline will represent a worse outcome. A higher score indicates worse symptoms.
Time frame: 90 days
Change in FOSQ-10 Questionnaire Scores
Functional Outcomes of Sleep Questionnaire (FOSQ-10) will be administered at baseline and 90 days. The unit for this outcome is points. The range of scores is 5 to 20. Higher scores indicate better functional status. A larger change or change that decreases from baseline will represent a better outcome. A smaller change or change that increases from baseline will represent a worse outcome.
Time frame: 90 days
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