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

ResMed

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Behavioral: Wellth app

Study type: Interventional

Funder types: Industry

Identifiers

NCT03851094

SLP-18-08-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 166 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 2 patient groups

Standard of Care (Group A)

No Intervention group

Description:

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

Wellth App (Group B)

Experimental group

Description:

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

Treatment:

Behavioral: Wellth app