SleepWell24: An Innovative Smartphone Application to Improve PAP Adherence
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|ClinicalTrials.gov Identifier: NCT03156283|
Recruitment Status : Recruiting
First Posted : May 17, 2017
Last Update Posted : January 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea of Adult||Behavioral: SleepWell24 Application Other: Usual Care Plus Activity Monitor||Not Applicable|
This exploratory study will test the feasibility and initial efficacy of a mobile health smartphone intervention to increase adherence to positive airway pressure (PAP) therapy in newly diagnosed obstructive sleep apnea (OSA) patients treated at the Mayo Clinic Arizona Center for Sleep Medicine and associated outpatient clinics. This app, called SleepWell24, will include PAP adherence behavior change strategies (drawn from the evidence-based Sleep Apnea Self-Management Program), cloud-based linkages to a consumer-based PAP machine and wearable sensor that provides nightly feedback on PAP adherence and sleep and activity metrics, and a component to enhance patient-provider communication. The investigators will embed SleepWell24 within usual patient care at the Mayo Clinic Arizona Center for Sleep Medicine and associated outpatient clinics for app design/development, patient recruitment, and treatment feasibility/satisfaction. This design will ensure the best opportunity for clinical adoption. The primary aims are:
Aim 1: Determine the feasibility and acceptability of SleepWell24 from patient and provider perspectives.
Aim 2: Determine the extent to which SleepWell24 improves PAP adherence over the first 60 days of use relative to usual care.
As an exploratory aim the investigators will explore the effect of SleepWell24 on treatment outcomes (weight, daytime sleepiness, cognitive performance, health-related quality of life) and putative social cognitive and behavioral mediators of PAP adherence (e.g., self-efficacy, sleep quality, sedentary behavior, physical activity).
The investigators will test the feasibility, acceptability, initial efficacy and outcomes of SleepWell24 compared to usual care during the first 60 days of PAP use among 94 patients newly diagnosed with obstructive sleep apnea.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||SleepWell24: An Innovative Smartphone Application to Improve PAP Adherence|
|Actual Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||July 31, 2019|
|Estimated Study Completion Date :||July 31, 2019|
Experimental: SleepWell24 Application
A mobile health smartphone application based on evidence-based health behavior change theory and interventions to promote adherence to positive airway pressure therapy
Behavioral: SleepWell24 Application
An evidence-based behavioral change smartphone application designed to promote adherence to positive airway pressure (PAP) therapy
Usual Care Plus Activity Monitor
Per usual clinical care standards within the Center for Sleep Medicine at Mayo Clinic Arizona, all patients will receive instructions/education on positive airway pressure (PAP) use, multiple mask fittings, encouragement to use PAP every night, and staff is available in the event of problems. Control patients will also receive a wearable activity monitor to use during the study. The wearable sensor will be used to isolate the effect of SleepWell24 on PAP adherence from potential novelty effects due to receiving a generic health behavior change app.
Other: Usual Care Plus Activity Monitor
Participants will receive usual care at the Mayo Clinic Center for Sleep Medicine when first diagnosed with sleep apnea and prescribed positive airway pressure therapy. In addition, they will receive a commercial activity monitor with an associated smartphone application to isolate the effect of SleepWell24 on PAP adherence from potential novelty effects due to receiving a generic health behavior change app.
- Recruitment and Retention [ Time Frame: Duration of the trial (~60 days) ]numbers recruited and retained over the course of the trial
- SleepWell24 application usage [ Time Frame: Duration of the trial (~60 days) ]objective metrics of smartphone application usage by intervention group
- Treatment acceptability/satisfaction [ Time Frame: Baseline vs. Day 60 of trial ]Intervention acceptability questionnaire for both groups
- Positive airway pressure therapy use [ Time Frame: Duration of the trial (~60 days) ]How many hours per night therapy was used throughout the trial
- Body Mass Index [ Time Frame: Baseline and follow-up visit between days 31 and 60 ]body mass index according to weight and height
- Daytime Sleepiness [ Time Frame: Baseline, Day 30, Day 60 of trial ]Epworth Sleepiness Scale
- Cognitive functioning [ Time Frame: Baseline and follow-up visit between days 31 and 60 ]Neurocognitive battery
- Global Quality of Life due to physical and mental health via the Patient Reported Outcomes Measurement Information System Global Health Scale [ Time Frame: Baseline, Day 30, Day 60 of trial ]The investigators will measure quality of life in general as informed by current physical and mental health using the quality of life in general as informed by current physical and mental health using the Patient Reported Outcomes Measurement Information System Global Health Scale. This Scale measures an individual's physical, mental, and social health, in general. This measure produces 2 scores: Physical Health and Mental Health. Summed raw scores are converted to T-score values with a mean of 50 and a standard deviation of 10. A higher T score indicates better Global Physical or Mental Health depending on the subscale used.
- Sleep Apnea-Specific Quality of Life [ Time Frame: Baseline, Day 30, Day 60 of trial ]The investigators will measure functional outcomes of sleep apnea with the Functional Outcomes of Sleep Questionnaire, which measures how difficult it is to carry out certain activities because of daytime sleepiness due to sleep apnea. It is a 10-item questionnaire representing 5 subscales. To obtain the total score, a mean-weighted item score is first computed for subscales with more than one item. Then the total score is derived by calculating the mean of the subscale scores and multiplying that mean by 5. Higher total scores indicate less difficulty with sleepiness due to sleep apnea affecting daytime activities. Scale ranges from 0 to 40.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03156283
|Contact: Megan E Petrov, PhD||602-496-2297||Megan.Petrov@asu.edu|
|United States, Arizona|
|Scottsdale, Arizona, United States, 85054|
|Contact: Lois Krahn, MD|
|Principal Investigator:||Megan E Petrov, PhD||Arizona State University|
|Principal Investigator:||Matthew Buman, PhD||Arizona State University|