A Phase 2/3 interventional study of Self-management and Telemonitored care in Sleep Apnea Syndromes, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-01.
Sponsored by VA Office of Research and Development · Phase 2/3, Interventional, and Treatment
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.
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 280 is above the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria were:
Active Intervention - Self-management: Self-management Educational component focused on sleep apnea and CPAP from a self-management perspective
Behavioral: Self-management
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
Self-management and Telemonitored care: Combination of both SM + TC intervention
Behavioral: Self-management · Behavioral: Telemonitored care
Control Group
Self-management
Telemonitored care
Nightly CPAP Adherence
Nightly CPAP adherence hours per night measured over the three-months period
Time frame: 3 mos
| Milestone | Self-Management (SM) | Telemonitored Care (TC) | SM + TC | Usual Care |
|---|---|---|---|---|
| Started | 65 | 67 | 75 | 73 |
| Completed | 65 | 67 | 75 | 73 |
| Not completed | 0 | 0 | 0 | 0 |
Nightly CPAP adherence hours per night measured over the three-months period
| hours per night | Self-management | Telemonitored Care | SM+TC | Usual Care |
|---|---|---|---|---|
| Nightly CPAP Adherence | 3.7 ± 1.8 | 3.7 ± 2.3 | 3.7 ± 2.2 | 3.2 ± 2.3 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Self-management | — | 0/65 (0%) | 0/65 (0%) |
| Telemonitored Care | — | 0/67 (0%) | 0/67 (0%) |
| SM+TC | — | 0/75 (0%) | 0/75 (0%) |
| Usual Care | — | 0/73 (0%) | 0/73 (0%) |
The target population for this study is all Veterans with OSA. It was expected that most participants would be middle-aged and older men and women, from a variety of ethnic backgrounds and with a full range of medical co-morbidities.
| Age, Categorical(Participants) | Self-management | Telemonitored Care | SM+TC | Usual Care | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 56 | 57 | 66 | 62 | 241 |
| >=65 years | 9 | 10 | 9 | 11 | 39 |
| Sex: Female, Male(Participants) | Self-management | Telemonitored Care | SM+TC | Usual Care | Total |
|---|---|---|---|---|---|
| Female | 3 | 2 | 1 | 3 | 9 |
| Male | 62 | 65 | 74 | 70 | 271 |
| Region of Enrollment(participants) | Self-management | Telemonitored Care | SM+TC | Usual Care | Total |
|---|---|---|---|---|---|
| United States | 65 | 67 | 75 | 73 | 280 |
Plan to share: No
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VA Office of Research and Development