NCT01259401

Brief Summary

The Veterans Millennium Health Care and Benefits Act (Millennium Act) of 1999 mandated the Department of Veterans Affairs (VA) to provide non-institutional long-term care to veterans. Adult Day Health Care (ADHC) is a key component of that spectrum of long-term care services. Veterans in ADHC commonly suffer from limited poor functioning, depression, cognitive problems and low quality of life. These factors can lead to continued deterioration in functioning, loss of independence, hospitalizations, nursing home placement and death. Sleep disruption is associated with depression, low quality of life, functional decline, nursing home placement, and death among older people. Sleep disturbance is common among ADHC patients, it is not addressed within routine clinical care, and treatment may be limited to medications. Studies show that untreated insomnia and medications for insomnia can increase risk of falls and other health events among older persons. On the other hand, non-medication treatments for sleep do not show these problems. These treatments have been shown to be effective in other studies. The goal of this study is to test non-medication treatments to improve sleep among older Veterans with insomnia in a VA ADHC program. The study design will facilitate translation into routine care and application in other similar VA programs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2010

Typical duration 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

Study Start

First participant enrolled

November 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 10, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 14, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

December 30, 2014

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

2.6 years

First QC Date

December 10, 2010

Results QC Date

December 17, 2014

Last Update Submit

February 5, 2025

Conditions

Keywords

SleepRehabilitationBehavior therapyInsomnia

Outcome Measures

Primary Outcomes (2)

  • Sleep Efficiency

    Percentage of time asleep while in bed estimated by actigraphy

    End of 4-week intervention

  • Sleep Efficiency

    Percentage of time asleep while in bed estimated by actigraphy.

    4-month follow-up

Study Arms (2)

SIP group

EXPERIMENTAL

The Sleep Intervention Program group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.

Behavioral: Sleep Intervention Program

Control group

ACTIVE COMPARATOR

The Control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care

Behavioral: Sleep Education control

Interventions

Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia.

SIP group

During sessions, participants reviewed two educational brochures that focused on changes in sleep with age and sleep hygiene education.

Control group

Eligibility Criteria

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

You may qualify if:

  • All of the following:
  • ADHC program participant
  • Age \>= 60 years
  • Ability to communicate verbally

You may not qualify if:

  • One or more of the following:
  • Significant cognitive impairment (Mini Mental State Examination score\<20)

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 (2)

  • Song Y, Dzierzewski JM, Fung CH, Rodriguez JC, Jouldjian S, Mitchell MN, Josephson KR, Alessi CA, Martin JL. Association Between Sleep and Physical Function in Older Veterans in an Adult Day Healthcare Program. J Am Geriatr Soc. 2015 Aug;63(8):1622-7. doi: 10.1111/jgs.13527. Epub 2015 Jul 22.

  • Martin JL, Song Y, Hughes J, Jouldjian S, Dzierzewski JM, Fung CH, Rodriguez Tapia JC, Mitchell MN, Alessi CA. A Four-Session Sleep Intervention Program Improves Sleep for Older Adult Day Health Care Participants: Results of a Randomized Controlled Trial. Sleep. 2017 Aug 1;40(8):zsx079. doi: 10.1093/sleep/zsx079.

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersSleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Small sample size; predominantly male study sample

Results Point of Contact

Title
Dr. Jennifer Martin
Organization
VA Greater Los Angeles Healthcare System

Study Officials

  • Jennifer Martin, PhD

    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
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2010

First Posted

December 14, 2010

Study Start

November 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

February 25, 2025

Results First Posted

December 30, 2014

Record last verified: 2025-02

Locations