Clinical trial NCT03851094: Evaluation of an Incentive-based Intervention to Improve 90-day Adherence in PAP-Naive Patients
Official title: Evaluation of an Incentive-based Intervention to Improve 90-day Adherence in PAP-Naive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: ResMed
Sponsor class: INDUSTRY
Collaborators: name: Wellth Inc.
First posted: 2019-02-22
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization will consist of an allocation ratio of 2:1 (control:treatment).
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Adult participants (≥ 18 years of age)
* New diagnosis of OSA
* Prescribed CPAP or APAP for treatment of OSA
* Prescribed a ResMed flow generator compatible with AirView
* Owns a smart phone and is willing to download an app on their phone
* Willing and able to give informed consent
* Can read and comprehend written and spoken English

Exclusion Criteria:

* Have used PAP therapy in the past
* Have been prescribed bi-level or adaptive servo-ventilation therapy
* Are participating in another app-based research study
* Cannot participate for the full duration of the study (at least 90 days)
* Participants who have a medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this study, or constitutes an unacceptable risk to the participant for the duration of the study

Primary outcomes:
measure: Mean PAP Usage at 90 Days
timeFrame: 90 days
Secondary outcomes:
measure: % of Participants That Meet Medicare Compliance Standard
timeFrame: 90 days
measure: Change in ESS Questionnaire Scores
timeFrame: 90 days
measure: Change in FOSQ-10 Questionnaire Scores
timeFrame: 90 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sleep Data
state: California
Study officials:
affiliation: ResMed
name: Gina Merchant, PhD
role: STUDY_DIRECTOR
References: