Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310310
Status:
COMPLETED
Last Update Posted:
2017-04-20
First Post:
2006-03-30
Brief Title:
Effect of Self-Management on Improving Sleep Apnea Outcomes
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Effect of Self-Management on Improving Sleep Apnea Outcomes
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None