Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232544
Status:
COMPLETED
Last Update Posted:
2018-10-10
First Post:
2005-09-30
Brief Title:
Telecommunications System in Sleep Apnea
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
RCT of a Telecommunications System in Sleep Apnea
Status:
COMPLETED
Status Verified Date:
2018-09
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:
This study is investigating the effects of a telecommunications system designed to improve patient adherence with prescribed positive airway pressure CPAP
Detailed Description:
BackgroundRationale
Obstructive sleep apnea syndrome OSAS is an important chronic disease of adults affecting an estimated 4 of men and 2 of women in the United States Nasal continuous positive airway pressure CPAP has been demonstrated to ameliorate the symptoms and neurobehavioral consequences of OSAS Unfortunately patient adherence with prescribed CPAP is low diminishing the benefits obtained from this expensive therapy Nurse-administered patient education and monitoring of CPAP use through home visits has been shown to be effective in significantly improving CPAP adherence Given the logistic complexity of delivering this service and its costs it is unlikely to be disseminated widely into clinical practice An alternative using advanced telecommunications technology to deliver similar adherence improvement services is proposed for study
Objectives
Use of telecommunications systems with other important health-related behaviors such as medication-taking diet and exercise have demonstrated significant improvements in therapy adherence
Methods
This research project represents a randomized controlled trial of a Telephone-Linked Communications TLC system designed to improve CPAP adherence TLC-CPAP The study will enroll adults with OSAS who are being started on nasal CPAP therapy Subjects will be randomized to TLC-CPAP or an attention placebo control group The effect of TLC on CPAP use and on disease-specific quality of life QOL OSAS-related symptoms depression and vigilance over a 12-month interval will be assessed
The intervention and control groups will be compared to assess differences in potential confounders including age sex OSAS severity CPAP pressure level comorbid illness physician specialty status BMI socioeconomic status and marital status Each of the outcome variables all of which are continuous variables will be compared between intervention and control groups using multivariate analyses to adjust for any potential confounders that differ between groups Multivariate models will include appropriate tests of interactions All analyses will be performed using an intent-to-treat approach
Status
Completed
Impact
This Telephone-Linked Communications TLC technology offers an effective low-cost and easy-to-use means of providing disease-specific education monitoring and counseling to improve adherence with therapy
Obstructive sleep apnea syndrome OSAS is an important chronic disease of adults affecting an estimated 4 of men and 2 of women in the United States Nasal continuous positive airway pressure CPAP has been demonstrated to ameliorate the symptoms and neurobehavioral consequences of OSAS Unfortunately patient adherence with prescribed CPAP is low diminishing the benefits obtained from this expensive therapy Nurse-administered patient education and monitoring of CPAP use through home visits has been shown to be effective in significantly improving CPAP adherence Given the logistic complexity of delivering this service and its costs it is unlikely to be disseminated widely into clinical practice An alternative using advanced telecommunications technology to deliver similar adherence improvement services is proposed for study
Objectives
Use of telecommunications systems with other important health-related behaviors such as medication-taking diet and exercise have demonstrated significant improvements in therapy adherence
Methods
This research project represents a randomized controlled trial of a Telephone-Linked Communications TLC system designed to improve CPAP adherence TLC-CPAP The study will enroll adults with OSAS who are being started on nasal CPAP therapy Subjects will be randomized to TLC-CPAP or an attention placebo control group The effect of TLC on CPAP use and on disease-specific quality of life QOL OSAS-related symptoms depression and vigilance over a 12-month interval will be assessed
The intervention and control groups will be compared to assess differences in potential confounders including age sex OSAS severity CPAP pressure level comorbid illness physician specialty status BMI socioeconomic status and marital status Each of the outcome variables all of which are continuous variables will be compared between intervention and control groups using multivariate analyses to adjust for any potential confounders that differ between groups Multivariate models will include appropriate tests of interactions All analyses will be performed using an intent-to-treat approach
Status
Completed
Impact
This Telephone-Linked Communications TLC technology offers an effective low-cost and easy-to-use means of providing disease-specific education monitoring and counseling to improve adherence with therapy
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