Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-06-30

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.

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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.

Conditions

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Sleep Apnea Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Self-Management (SM)

Active Intervention - Self-management: Self-management Educational component focused on sleep apnea and CPAP from a self-management perspective

Group Type EXPERIMENTAL

Self-management

Intervention Type BEHAVIORAL

Self-management

Telemonitored Care (TC)

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

Group Type ACTIVE_COMPARATOR

Telemonitored care

Intervention Type BEHAVIORAL

Telemonitored care

SM + TC

Self-management and Telemonitored care: Combination of both SM + TC intervention

Group Type EXPERIMENTAL

Self-management

Intervention Type BEHAVIORAL

Self-management

Telemonitored care

Intervention Type BEHAVIORAL

Telemonitored care

Usual care (UC)

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Self-management

Intervention Type BEHAVIORAL

Telemonitored care

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of OSA
2. Prescription for CPAP treatment by a sleep physician
3. Being CPAP naïve (ie, no previous use of CPAP).

Exclusion Criteria

1. Residence in a geographical area outside of San Diego County
2. Fatal comorbidity (life expectancy less than 6 months as indicated by treating physician)
3. Significant documented substance/chemical abuse

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No