Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring

Study Overview
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Brief Summary
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Obstructive sleep apnea (OSA) is a major chronic condition affecting the quality of life of up to one-fifth of all Veterans. Because of disappointingly low adherence to the gold-standard treatment (continuous positive airway pressure therapy - CPAP), the Institute of Medicine has stated that new adherence strategies are needed that improve the quality of care, reduce social and economic costs, and help OSA patients live happier, healthier, and more productive lives through improved clinical management. The combination of a self-management approach along with emerging wireless technologies has strong potential to increase treatment adherence and improve outcomes.

Detailed Description
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The Sleep Apnea Self-Management Program (SASMP) was evaluated by conducting a randomized, controlled trial of the program compared to Usual Care in patients diagnosed with OSA and prescribed CPAP therapy. Participants randomized to the SASMP group attended 4 weekly educational sessions of approximately two hours each. A trained leader facilitated the program from a scripted manual. Key topics covered in this program included: (1) management of OSA symptoms, CPAP side effects, and weight loss; (2) maintaining social contacts and family relationships; and (3) dealing with symptoms of depression and worries about the future. The primary aim of this study was to examine the effect of the SASMP, compared to Usual Care, on CPAP adherence. It is hypothesized that SASMP participants will have higher levels of CPAP adherence compared to those in the Usual Care group. A second aim of the study was to examine the effect of the SASMP, compared to Usual Care, on proposed mediating variables derived from social cognitive theory (perceived self-efficacy, outcome expectations). It is hypothesized that SASMP participants would have higher levels of self-efficacy and outcome expectations compared to the Usual Care group. And the third aim of the study was to measure the short- and long-term effects of the SASMP, compared to Usual Care, on health outcomes (e.g., OSA symptoms and OSA-specific HRQOL). It is hypothesized that improvements in OSA symptoms and OSA-specific HRQOL will be seen both initially and as maintained 6 months and 1 year after the start of the SASMP.

Official Title
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Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring

Conditions
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Sleep Apnea Syndromes

Intervention / Treatment
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* Behavioral: Self-management
* Behavioral: Telemonitored care


Participation Criteria
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Eligibility Criteria
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Inclusion criteria were: Diagnosis of OSA Prescription for CPAP treatment by a sleep physician Being CPAP naïve (ie, no previous use of CPAP). Exclusion criteria were: Residence in a geographical area outside of San Diego County Fatal comorbidity (life expectancy less than 6 months as indicated by treating physician) Significant documented substance/chemical abuse

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-Management (SM)<br>Active Intervention - Self-management: Self-management Educational component focused on sleep apnea and CPAP from a self-management perspective | Behavioral: Self-management<br>* Self-management<br>|
| Active Comparator: Telemonitored Care (TC)<br>Active Comparator - Telemonitored care: Telemonitored care Consists of CPAP therapist actively monitoring care at a distance, and acting on that data per a set protocol | Behavioral: Telemonitored care<br>* Telemonitored care<br>|
| Experimental: SM + TC<br>Self-management and Telemonitored care: Combination of both SM + TC intervention | Behavioral: Self-management<br>* Self-management<br>Behavioral: Telemonitored care<br>* Telemonitored care<br>|
| No Intervention: Usual care (UC)<br>Control Group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nightly CPAP Adherence | Nightly CPAP adherence hours per night measured over the three-months period | 3 mos | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment compliance, Self-management, Telemedicine