Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring
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|ClinicalTrials.gov Identifier: NCT00682838|
Recruitment Status : Completed
First Posted : May 22, 2008
Results First Posted : September 1, 2016
Last Update Posted : September 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea Syndromes||Behavioral: Self-management Behavioral: Telemonitored care||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring|
|Study Start Date :||July 2009|
|Primary Completion Date :||May 2012|
|Study Completion Date :||June 2012|
Experimental: Self-Management (SM)
Active Intervention - Self-management: Self-management Educational component focused on sleep apnea and CPAP from a self-management perspective
Active Comparator: 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
Behavioral: Telemonitored care
Experimental: SM + TC
Self-management and Telemonitored care: Combination of both SM + TC intervention
Self-managementBehavioral: Telemonitored care
No Intervention: Usual care (UC)
- Nightly CPAP Adherence [ Time Frame: 3 mos ]Nightly CPAP adherence hours per night measured over the three-months period
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): NCT00682838
|United States, California|
|VA San Diego Healthcare System|
|San Diego, California, United States, 92161|
|Principal Investigator:||Carl J Stepnowsky, PhD||San Diego Veterans Healthcare System|