Evaluation of a Health Dashboard Intervention to Improve Engagement With CPAP Therapy in PAP-Naïve Patients: Project Neo

May 28, 2021 updated by: ResMed
This is a prospective, open-label study to evaluate the effectiveness of providing a dashboard with merged health metrics of CPAP (continuous positive airway pressure/ PAP) usage, self-reported sleepiness, blood pressure (BP) and activity (steps).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Bella Vista, New South Wales, Australia, 2153
        • ResMed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant is at least 18 years old.
  • Participant is using a ResMed AirSense 10 device and ResMed myAir mobile app.
  • Participant has been using CPAP therapy for less than 2 weeks.
  • Participant has been enrolled in myAir for less than 2 weeks.
  • Participants have self-reported resistant hypertension and they take 3 or more drugs to treat their hypertension.
  • Participant owns a mobile device compatible with the Neo app (Android Jelly Bean, v16, 4.1.x or newer, and iOS 8 or newer)
  • Participant is somewhat to fairly confident about being able to use Bluetooth connected devices and apps
  • Participant consents to download the Neo app, Withings app, create a Withings account, and sync Withings data to ResMed's Project Neo.
  • Willing and able to give informed consent
  • Can read and comprehend written and spoken English

Exclusion Criteria:

  • Are participating in another app-based research study
  • Cannot participate for the full duration of the study (at least 45 days)
  • Unable to read or write English
  • Participant is pregnant
  • Participant is on Medicare

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Other: Neo App
Neo is a smartphone-based dashboard application that utilizes concepts from behavioral science and health psychology to support patients to improve their adherence to therapy. This is done through behavior change techniques and intervention functions (Michie, Atkins & West, 2014). This app is designed to prompt participants' self-regulation of lifestyle and health behaviors, to support adherence to therapy. Such self-regulation of lifestyle behaviors is informed by presenting health metric data (through wearables, myAir (biofeedback) and self-report), in an easy to understand dashboard platform on the app. Participants will be asked to use their PAP device (as normal), use a Withings blood pressure cuff and activity monitor. This data is brought into the Neo app through an API Exchange gateway. This data will be presented to the participant and communicated in an easy to understand way.
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean CPAP use hours
Time Frame: 6 weeks
Mean PAP use hours (mean hours per day) at 6 weeks following enrollment into the study compared to the control group.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
App Use
Time Frame: 6 weeks
Percentage of participants that actively use the Neo app as determined by daily active users, weekly active users and time spent in the app.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ResMed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2020

Primary Completion (Actual)

December 19, 2020

Study Completion (Actual)

March 25, 2021

Study Registration Dates

First Submitted

May 28, 2021

First Submitted That Met QC Criteria

May 28, 2021

First Posted (Actual)

June 3, 2021

Study Record Updates

Last Update Posted (Actual)

June 3, 2021

Last Update Submitted That Met QC Criteria

May 28, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHT-20-06-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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