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

NCT ID: NCT03851094

Last Updated: 2021-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-11
• Study Completion Date: 2020-08-16

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care (Group A)

Standard of care is dictated by the HME normal practices for new CPAP patients.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Wellth App (Group B)

Intervention is use of the Wellth app during the initial compliance period.

Group Type: EXPERIMENTAL

Wellth app

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Restful

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wellth Inc.

INDUSTRY

Sponsor Role: collaborator

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gina Merchant, PhD

Role: STUDY_DIRECTOR

ResMed

Locations

Sleep Data

San Diego, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

SLP-18-08-01

Identifier Type: -

Identifier Source: org_study_id