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

NCT03851094 | Completed Results

• 1 other identifier: SLP-18-08-01
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Mean PAP Usage at 90 Days

  Average nightly CPAP use for the 90 day time frame.

  90 days

Secondary Outcomes (3)

• % of Participants That Meet Medicare Compliance Standard

  90 days

• Change in ESS Questionnaire Scores

  90 days

• Change in FOSQ-10 Questionnaire Scores

  90 days

Study Arms (2)

Standard of Care (Group A)

NO INTERVENTION

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

Wellth App (Group B)

EXPERIMENTAL

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

Behavioral: Wellth app

Interventions

Wellth app 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.

Also known as: Restful

Wellth App (Group B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead
• Wellth Inc.: collaborator

Study Sites (1)

Sleep Data

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Clinical Research Team
• Organization: ResMed

clinicaltrials@resmed.com.au

800-424-0737

Study Officials

• Gina Merchant, PhD

  ResMed

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization will consist of an allocation ratio of 2:1 (control:treatment).

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 22, 2019
• Study Start: March 11, 2019
• Primary Completion: May 18, 2020
• Study Completion: August 16, 2020
• Last Updated: June 15, 2021
• Results First Posted: June 15, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)