Non-Pharmacological Interventions on Sleep in Post-Acute Rehabilitation

Not Applicable

Completed

• Conditions: Sleep Disorders
• Interventions: Behavioral: Active control; Behavioral: Nonpharmacological sleep intervention

• Registration Number: NCT00333619
• Lead Sponsor: US Department of Veterans Affairs

Brief Summary

This project is a randomized controlled trial to test whether a multicomponent, nonpharmacological intervention improves sleep/wake 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 sleep/wake 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 sleep/wake 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 intervention/control 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-06-02
• Study First Submitted QC: 2006-06-02
• Study First Posted: 2006-06-06
• Study Start: 2007-01
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2014-10
• Results First Submitted: 2014-10-23
• Results First Submitted QC: 2015-03-23
• Results First Posted: 2015-04-06
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

Inclusion Criteria

• Adults aged > or = 60, who are admitted to inpatient rehabilitation services, who lived in a non-institutional setting prior to admission, and are admitted for rehabilitation

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Exclusion Criteria

• severe sleep apnea
• severe cognitive impairment
• not enrolled within one week of admission to rehabilitation unit
• too ill to participate
• and planned discharge to a nursing home for total nursing care

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active control	Active control	Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).
Nonpharmacological sleep intervention	Nonpharmacological sleep intervention	The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.

Primary Outcome Measures

Name	Time	Method
Sleep Efficiency	3-month follow-up	Average sleep efficiency calculated from 7 days of actigraphy. Sleep efficiency for each night is calculated as the number of hours asleep divided by the number of hours in bed.
Pittsburgh Sleep Quality Index	3-month follow-up	The PSQI is a 18-item questionnaire that measures subjective sleep quality and sleep disturbances (total score ranging from 0 - 21; score \> 8 indicates poor sleep quality).

Trial Locations

Locations (1)

VA Greater Los Angeles Healthcare System, Sepulveda, CA; 🇺🇸 Sepulveda, California, United States