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Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring

This study has been completed.
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00682838
First received: May 12, 2008
Last updated: July 20, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention Phase
Sleep Apnea Syndromes
Behavioral: Self-management
Behavioral: Telemonitored care
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Nightly CPAP Adherence [ Time Frame: 3 mos ] [ Designated as safety issue: No ]
    Nightly CPAP adherence hours per night measured over the three-months period


Enrollment: 280
Study Start Date: July 2009
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Self-Management (SM)
Active Intervention - Self-management: Self-management Educational component focused on sleep apnea and CPAP from a self-management perspective
Behavioral: Self-management
Self-management
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
Telemonitored care
Experimental: SM + TC
Self-management and Telemonitored care: Combination of both SM + TC intervention
Behavioral: Self-management
Self-management
Behavioral: Telemonitored care
Telemonitored care
No Intervention: Usual care (UC)
Control Group

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682838

Locations
United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161
Sponsors and Collaborators
VA Office of Research and Development
University of California, San Diego
Investigators
Principal Investigator: Carl J Stepnowsky, PhD San Diego Veterans Healthcare System
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00682838     History of Changes
Other Study ID Numbers: IIR 07-163  080139 
Study First Received: May 12, 2008
Results First Received: July 8, 2015
Last Updated: July 20, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
Treatment compliance
Self-management
Telemedicine

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 26, 2016