NCT00333619

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2006

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

April 6, 2015

Completed
Last Updated

April 24, 2015

Status Verified

October 1, 2014

Enrollment Period

3.9 years

First QC Date

June 2, 2006

Results QC Date

October 23, 2014

Last Update Submit

April 6, 2015

Conditions

Sleep Disorders

Keywords

sleep disordersrehabilitationrehabilitation outcomes

Outcome Measures

Primary Outcomes (2)

  • Pittsburgh Sleep Quality Index

    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).

    3-month follow-up

  • Sleep Efficiency

    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.

    3-month follow-up

Study Arms (2)

Nonpharmacological sleep intervention

EXPERIMENTAL

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.

Behavioral: Nonpharmacological sleep intervention

Active control

ACTIVE COMPARATOR

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).

Behavioral: Active control

Interventions

Nonpharmacological sleep interventionBEHAVIORAL

The intervention combines: 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

Nonpharmacological sleep intervention
Active controlBEHAVIORAL

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).

Active control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Sepulveda, California, 91343, United States

Location

Related Publications (3)

  • Martin JL, Jouldjian S, Mitchell MN, Josephson KR, Alessi CA. A longitudinal study of poor sleep after inpatient post-acute rehabilitation: the role of depression and pre-illness sleep quality. Am J Geriatr Psychiatry. 2012 Jun;20(6):477-84. doi: 10.1097/JGP.0b013e31824877c1.

    PMID: 22617164RESULT

  • Skibitsky M, Edelen MO, Martin JL, Harker J, Alessi C, Saliba D. Can standardized sleep questionnaires be used to identify excessive daytime sleeping in older post-acute rehabilitation patients? J Am Med Dir Assoc. 2012 Feb;13(2):127-35. doi: 10.1016/j.jamda.2010.05.004. Epub 2010 Oct 2.

    PMID: 21450184RESULT

  • Martin JL, Dzierzewski JM, Mitchell M, Fung CH, Jouldjian S, Alessi CA. Patterns of sleep quality during and after postacute rehabilitation in older adults: a latent class analysis approach. J Sleep Res. 2013 Dec;22(6):640-7. doi: 10.1111/jsr.12066. Epub 2013 Jul 8.

    PMID: 23834036RESULT

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Results Point of Contact

Title
Dr. Cathy Alessi
Organization
VA Greater Los Angeles Healthcare System
cathy.alessi@va.gov
818 895-9311

Study Officials

  • Cathy A. Alessi, MD

    VA Greater Los Angeles Healthcare System, Sepulveda, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2006

First Posted

June 6, 2006

Study Start

January 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 24, 2015

Results First Posted

April 6, 2015

Record last verified: 2014-10

Locations

US(1)