Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring
Primary Purpose
Sleep Apnea Syndromes
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Self-management
Telemonitored care
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea Syndromes focused on measuring Treatment compliance, Self-management, Telemedicine
Eligibility Criteria
Inclusion criteria were:
- Diagnosis of OSA
- Prescription for CPAP treatment by a sleep physician
- Being CPAP naïve (ie, no previous use of CPAP).
Exclusion criteria were:
- Residence in a geographical area outside of San Diego County
- Fatal comorbidity (life expectancy less than 6 months as indicated by treating physician)
- Significant documented substance/chemical abuse
Sites / Locations
- VA San Diego Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
No Intervention
Arm Label
Self-Management (SM)
Telemonitored Care (TC)
SM + TC
Usual care (UC)
Arm Description
Active Intervention - Self-management: Self-management Educational component focused on sleep apnea and CPAP from a self-management perspective
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
Self-management and Telemonitored care: Combination of both SM + TC intervention
Control Group
Outcomes
Primary Outcome Measures
Nightly CPAP Adherence
Nightly CPAP adherence hours per night measured over the three-months period
Secondary Outcome Measures
Full Information
NCT ID
NCT00682838
First Posted
May 12, 2008
Last Updated
July 20, 2016
Sponsor
VA Office of Research and Development
Collaborators
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT00682838
Brief Title
Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring
Official Title
Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
University of California, San Diego
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes
Keywords
Treatment compliance, Self-management, Telemedicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-Management (SM)
Arm Type
Experimental
Arm Description
Active Intervention - Self-management: Self-management Educational component focused on sleep apnea and CPAP from a self-management perspective
Arm Title
Telemonitored Care (TC)
Arm Type
Active Comparator
Arm Description
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
Arm Title
SM + TC
Arm Type
Experimental
Arm Description
Self-management and Telemonitored care: Combination of both SM + TC intervention
Arm Title
Usual care (UC)
Arm Type
No Intervention
Arm Description
Control Group
Intervention Type
Behavioral
Intervention Name(s)
Self-management
Intervention Description
Self-management
Intervention Type
Behavioral
Intervention Name(s)
Telemonitored care
Intervention Description
Telemonitored care
Primary Outcome Measure Information:
Title
Nightly CPAP Adherence
Description
Nightly CPAP adherence hours per night measured over the three-months period
Time Frame
3 mos
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria were:
Diagnosis of OSA
Prescription for CPAP treatment by a sleep physician
Being CPAP naïve (ie, no previous use of CPAP).
Exclusion criteria were:
Residence in a geographical area outside of San Diego County
Fatal comorbidity (life expectancy less than 6 months as indicated by treating physician)
Significant documented substance/chemical abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl J Stepnowsky, PhD
Organizational Affiliation
San Diego Veterans Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring
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