Non-Pharmacological Interventions on Sleep in Post-Acute Rehabilitation

US Department of Veterans Affairs (VA)

Status: Completed

Conditions: Sleep Disorders

Treatments: Behavioral: Active control; Behavioral: Nonpharmacological sleep intervention

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00333619

IIR 04-321

Details and patient eligibility

About

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.

Full 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.

Enrollment: 219 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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219 participants in 2 patient groups

Nonpharmacological sleep intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Nonpharmacological sleep intervention

Active control

Active Comparator group

Description:

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).

Treatment:

Behavioral: Active control