Sleep Apnea Syndromes
Conditions
Keywords
Treatment compliance, Self-management, Telemedicine
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.
Interventions
BEHAVIORALSelf-management
Self-management
BEHAVIORALTelemonitored care
Telemonitored care
Sponsors
University of California, San Diego
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nightly CPAP Adherence | 3 mos | Nightly CPAP adherence hours per night measured over the three-months period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Self-management Active Intervention
Self-management: Self-management | 65 |
| Telemonitored Care Active Comparator
Telemonitored care: Telemonitored care | 67 |
| SM+TC 1+2
Self-management: Self-management
Telemonitored care: Telemonitored care | 75 |
| Usual Care Usual care- control group | 73 |
| Total | 280 |
Baseline characteristics
| Characteristic | Self-management | Telemonitored Care | SM+TC | Usual Care | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 10 Participants | 9 Participants | 11 Participants | 39 Participants |
| Age, Categorical Between 18 and 65 years | 56 Participants | 57 Participants | 66 Participants | 62 Participants | 241 Participants |
| Region of Enrollment United States | 65 participants | 67 participants | 75 participants | 73 participants | 280 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 1 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Male | 62 Participants | 65 Participants | 74 Participants | 70 Participants | 271 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 65 | 0 / 67 | 0 / 75 | 0 / 73 |
| serious Total, serious adverse events | 0 / 65 | 0 / 67 | 0 / 75 | 0 / 73 |
Outcome results
Primary
Nightly CPAP Adherence
Nightly CPAP adherence hours per night measured over the three-months period
Time frame: 3 mos
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-management | Nightly CPAP Adherence | 3.7 hours per night | Standard Deviation 1.8 |
| Telemonitored Care | Nightly CPAP Adherence | 3.7 hours per night | Standard Deviation 2.3 |
| SM+TC | Nightly CPAP Adherence | 3.7 hours per night | Standard Deviation 2.2 |
| Usual Care | Nightly CPAP Adherence | 3.2 hours per night | Standard Deviation 2.3 |
p-value: 0.5t-test, 1 sided