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| ID | Type | Description | Link |
|---|---|---|---|
| 080139 | Other Identifier | UCSD IRB |
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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-Management (SM) | Experimental | Active Intervention - Self-management: Self-management Educational component focused on sleep apnea and CPAP from a self-management perspective |
|
| Telemonitored Care (TC) | Active Comparator | 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 |
|
| SM + TC | Experimental | Self-management and Telemonitored care: Combination of both SM + TC intervention |
|
| Usual care (UC) | No Intervention | Control Group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-management | Behavioral | Self-management |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Nightly CPAP Adherence | Nightly CPAP adherence hours per night measured over the three-months period | 3 mos |
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Inclusion criteria were:
Exclusion criteria were:
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| Name | Affiliation | Role |
|---|---|---|
| Carl J Stepnowsky, PhD | San Diego Veterans Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System | San Diego | California | 92161 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Self-Management (SM) | Active Intervention Self-management: Self-management Educational component focused on sleep apnea and CPAP from a self-management perspective |
| FG001 | 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 |
| FG002 | SM + TC | 1+2 Self-management: Self-management Telemonitored care: Telemonitored care Combination of both SM + TC intervention |
| FG003 | Usual Care | Usual care- control group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Self-management | Active Intervention Self-management: Self-management |
| BG001 | Telemonitored Care | Active Comparator Telemonitored care: Telemonitored care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Nightly CPAP Adherence | Nightly CPAP adherence hours per night measured over the three-months period | Posted | Mean | Standard Deviation | hours per night | 3 mos |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Self-management | Active Intervention Self-management: Self-management |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carl J. Stepnowsky, PhD | VA San Diego Healthcare System | 858-642-1240 | Carl.Stepnowsky@va.gov |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D000073278 | Self-Management |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Telemonitored care |
| Behavioral |
Telemonitored care |
|
| BG002 | SM+TC | 1+2 Self-management: Self-management Telemonitored care: Telemonitored care |
| BG003 | Usual Care | Usual care- control group |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | Usual Care | Usual care- control group |
|
|
|
| 0 |
| 65 |
| 0 |
| 65 |
| EG001 | Telemonitored Care | Active Comparator Telemonitored care: Telemonitored care | 0 | 67 | 0 | 67 |
| EG002 | SM+TC | 1+2 Self-management: Self-management Telemonitored care: Telemonitored care | 0 | 75 | 0 | 75 |
| EG003 | Usual Care | Control Group | 0 | 73 | 0 | 73 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |