Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00333619
Status:
COMPLETED
Last Update Posted:
2015-04-24
First Post:
2006-06-02
Brief Title:
Non-Pharmacological Interventions on Sleep in Post-Acute Rehabilitation
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Non-Pharmacological Interventions on Sleep in Post-Acute Rehabilitation
Status:
COMPLETED
Status Verified Date:
2014-10
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 project is a randomized controlled trial to test whether a multicomponent nonpharmacological intervention improves sleepwake patterns and functional recovery among older people undergoing post-acute rehabilitation
Detailed Description:
The purpose of this study is to perform a randomized controlled trial to test whether a multicomponent nonpharmacological intervention improves sleepwake patterns and functional recovery among older people N 214 undergoing post-acute rehabilitation The intervention will combine 1 structured sleep assessment 2 patient education in key elements of cognitive behavioral strategies to improve sleep and 3 environmental interventions on factors which likely contribute to abnormal sleepwake patterns in the post-acute rehabilitation setting
This project will be conducted in a VA post-acute rehabilitation site Older veterans 60 years who were previously community-dwelling N 214 will be randomized to receive the intervention or a social contact and memory skills training program as the control condition Data collected at baseline will include medical data and demographics as well as subjective and objective measures of sleep structured assessments of functional status and medical comorbidity Follow-up assessments will be performed in the facility while the interventioncontrol condition is in place and at three months and six months after discharge from rehabilitation The main outcome measures will include objective sleep measures nighttime percent sleep and daytime percent sleep and functional status collected at three and six months follow-up Data will be analyzed for all randomized participants in an intention to treat analysis
This project will be conducted in a VA post-acute rehabilitation site Older veterans 60 years who were previously community-dwelling N 214 will be randomized to receive the intervention or a social contact and memory skills training program as the control condition Data collected at baseline will include medical data and demographics as well as subjective and objective measures of sleep structured assessments of functional status and medical comorbidity Follow-up assessments will be performed in the facility while the interventioncontrol condition is in place and at three months and six months after discharge from rehabilitation The main outcome measures will include objective sleep measures nighttime percent sleep and daytime percent sleep and functional status collected at three and six months follow-up Data will be analyzed for all randomized participants in an intention to treat analysis
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