Effect of Self-Management on Improving Sleep Apnea Outcomes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00310310
First received: March 30, 2006
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Sleep Apnea Syndromes
Behavioral: Sleep Apnea Self-Management Program
Behavioral: Usual care
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Official Title: Effect of Self-Management on Improving Sleep Apnea Outcomes

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • CPAP adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Perceived self-efficacy, outcome expectations and reduced sleep apnea symptoms at post-intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: April 2006
Study Completion Date: December 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 1
Usual sleep apnea and cpap care
Behavioral: Usual care
Usual sleep apnea and cpap care
Experimental: Arm 2
sleep apnea self-management program - 4 sessions, group-based
Behavioral: Sleep Apnea Self-Management Program
Sleep apnea self-management program - 4 sessions, group-based.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00310310

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

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00310310     History of Changes
Other Study ID Numbers: IIR 02-275
Study First Received: March 30, 2006
Last Updated: July 14, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Continuous positive airway pressure
Patient compliance
Self-care

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

ClinicalTrials.gov processed this record on July 22, 2014