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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2020

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • No Intervention: Group A
  • Experimental: Group B
    • Wellth app

Clinical Trial Outcome Measures

Primary Measures

  • Mean PAP usage at 90 days
    • Time Frame: 90 days

Secondary Measures

  • % of participants that meet Medicare compliance standard
    • Time Frame: 90 days
    • 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
  • Change in ESS questionnaire scores
    • Time Frame: 90 days
    • FOSQ-10 will be administered at baseline and 90 days. The unit for this outcome is points. 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.
  • Change in FOSQ-10 questionnaire scores
    • Time Frame: 90 days
    • FOSQ-10 will be administered at baseline and 90 days. The unit for this outcome is points. 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.
  • Baseline scores of perceived disease severity
    • Time Frame: 90 days
    • These baseline scores will be used as moderators of the intervention’s effectiveness. The unit for this outcome is points. A higher score will have more of an influence on the relationship between the primary outcome (mean PAP usage) and the intervention.
  • Baseline scores of claustrophobia
    • Time Frame: 90 days
    • These baseline scores will be used as moderators of the intervention’s effectiveness. The unit for this outcome is points. A higher score will have more of an influence on the relationship between the primary outcome (mean PAP usage) and the intervention.
  • Baseline scores of coping skills
    • Time Frame: 90 days
    • These baseline scores will be used as moderators of the intervention’s effectiveness. The unit for this outcome is points. A higher score will have more of an influence on the relationship between the primary outcome (mean PAP usage) and the intervention.
  • Baseline scores of health literacy
    • Time Frame: 90 days
    • These baseline scores will be used as moderators of the intervention’s effectiveness. The unit for this outcome is points. A higher score will have more of an influence on the relationship between the primary outcome (mean PAP usage) and the intervention.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ResMed
  • Collaborator
    • Wellth Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gina Merchant, PhD, Study Director, ResMed
  • Overall Contact(s)
    • Kate Valentine, 858-836-6836, kate.valentine@resmed.com

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