Clinical trial NCT00682838: Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring
Official title: Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Sleep Apnea Syndromes
Keywords: Treatment compliance
Self-management
Telemedicine
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of California, San Diego
First posted: 2008-05-22
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion criteria were:

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 were:

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

Primary outcomes:
measure: Nightly CPAP Adherence
timeFrame: 3 mos
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
Study officials:
affiliation: San Diego Veterans Healthcare System
name: Carl J Stepnowsky, PhD
role: PRINCIPAL_INVESTIGATOR
References: