NCT03851094

Evaluation of an Incentive-based Intervention to Improve 90-day Adherence in PAP-Naive Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
BEHAVIORAL	Wellth app	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.

Timeline

• Start date: 2019-03-11
• Primary completion: 2020-05-18
• Completion: 2020-08-16
• First posted: 2019-02-22
• Last updated: 2021-06-15
• Results posted: 2021-06-15

Locations

1 site across 1 country: United States