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Effect of Self-Management on Improving Sleep Apnea Outcomes
This study is ongoing, but not recruiting participants.
Study NCT00310310   Information provided by Department of Veterans Affairs
First Received: March 30, 2006   Last Updated: September 25, 2009   History of Changes

March 30, 2006
September 25, 2009
April 2006
May 2009   (final data collection date for primary outcome measure)
CPAP adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
CPAP adherence at 6 months
Complete list of historical versions of study NCT00310310 on ClinicalTrials.gov Archive Site
Perceived self-efficacy, outcome expectations and reduced sleep apnea symptoms at post-intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Perceived self-efficacy, outcome expectations and reduced sleep apnea symptoms at post-intervention
 
Effect of Self-Management on Improving Sleep Apnea Outcomes
Effect of Self-Management on Improving Sleep Apnea Outcomes

Obstructive sleep apnea syndrome (OSA) is a common sleep disorder that is associated with serious medical and psychological complications. Nasal continuous positive airway pressure (CPAP) is the treatment of choice for this condition because it is highly effective in reducing the frequency of nocturnal respiratory events, improving sleep architecture, decreasing daytime sleepiness and improving blood pressure. Incomplete patient adherence, however, limits the effectiveness of CPAP therapy and results in sub-optimal patient outcomes. Previous efforts to enhance CPAP adherence have resulted in only modest improvements, have generally not been theory-driven, and have had minimal effects on key patient outcomes such as reduction in OSA symptoms or increase in health-related quality of life (HRQOL). The planned intervention in this proposal, the Sleep Apnea Self-Management Program (SASMP), is based on the rationale that sleep apnea is a chronic disease that requires significant self-care on the part of the patient. We draw on the extensive chronic disease self-management literature to provide a solid theoretical justification for this pragmatic intervention both to better manage key aspects of OSA and to increase CPAP adherence. Chronic disease management programs help reduce symptoms, improve HRQOL, improve treatment adherence, and decrease medical utilization.

Background: Obstructive sleep apnea syndrome (OSA) is a common sleep disorder that is associated with serious medical and psychological complications. Nasal continuous positive airway pressure (CPAP) is the treatment of choice for this condition because it is highly effective in reducing the frequency of nocturnal respiratory events, improving sleep architecture, decreasing daytime sleepiness and improving blood pressure. Incomplete patient adherence, however, limits the effectiveness of CPAP therapy and results in sub-optimal patient outcomes. Previous efforts to enhance CPAP adherence have resulted in only modest improvements, have generally not been theory-driven, and have had minimal effects on key patient outcomes such as reduction in OSA symptoms or increase in health-related quality of life (HRQOL). The planned intervention in this proposal, the Sleep Apnea Self-Management Program (SASMP), is based on the rationale that sleep apnea is a chronic disease that requires significant self-care on the part of the patient. We draw on the extensive chronic disease self-management literature to provide a solid theoretical justification for this pragmatic intervention both to better manage key aspects of OSA and to increase CPAP adherence. Chronic disease management programs help reduce symptoms, improve HRQOL, improve treatment adherence, and decrease medical utilization. Objectives: The primary aim of this study is to compare the efficacy of the SASMP to Usual Care for improving OSA symptom status, HRQOL, and self-reported medical utilization. A second aim is to examine the extent to which changes in symptoms and HRQOL are mediated by changes in self-efficacy and CPAP adherence. Methods: We will evaluate the Sleep Apnea Self-Management Program (SASMP) 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 will attend 4 weekly educational sessions of 2.5 hours each. Two trained leaders facilitate the program from a scripted manual. Key topics covered in this program include 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. Findings: No results at this time. Status: We are currently engaging in start-up activities. Impact: The results of this project can improve service delivery and improve health outcomes for sleep apnea patients at the Veterans Affairs San Diego Healthcare System, throughout the VA, as well as to any community based sleep clinic.

Phase II, Phase III
Interventional
Other, Randomized, Single Blind (Subject), Active Control, Single Group Assignment, Efficacy Study
Sleep Apnea Syndromes
  • Behavioral: Sleep Apnea Self-Management Program
  • Behavioral: Usual care
  • Placebo Comparator: Usual sleep apnea and cpap care
  • Experimental: sleep apnea self-management program - 4 sessions, group-based

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
240
March 2010
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of obstructive sleep apnea
  • No previous use of CPAP
  • Must be a Veteran with residence within San Diego County

Exclusion Criteria:

  • Home oxygen therapy
  • Fatal comorbidities (i.e., life expectancy less than 6 mos)
  • Contraindications for CPAP use
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00310310
Stepnowsky, Carl - Principal Investigator, Department of Veterans Affairs
IIR 02-275, UCSD HRPP #050717
Department of Veterans Affairs
 
Principal Investigator: Carl J. Stepnowsky, PhD VA San Diego Healthcare System
Department of Veterans Affairs
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP