Treating Sleep Problems in VA Adult Day Health Care (HERO-ADHC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01259401
First received: December 10, 2010
Last updated: September 17, 2013
Last verified: September 2013

December 10, 2010
September 17, 2013
November 2010
June 2013   (final data collection date for primary outcome measure)
Sleep quality based on self-report measures and objective monitoring (wrist actigraphy) [ Time Frame: 1 week post-treatment and 4-months follow-up ] [ Designated as safety issue: No ]
Sleep quality based on self-report measures and objective monitoring (wrist actigraphy) [ Time Frame: Post-treatment and 6-months follow-up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01259401 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Treating Sleep Problems in VA Adult Day Health Care
Treating Sleep Problems in VA Adult Day Health Care

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.

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. ADHC provides health maintenance, rehabilitation services and socialization in a group setting during daytime hours. Veterans in ADHC commonly suffer from limited physical functioning, depression, cognitive difficulties and low quality of life. These factors increase the likelihood of continued deterioration in functioning, loss of independence, hospitalizations, nursing home placement and death. Previous studies, including our own work, have demonstrated that sleep disruption is associated with depression, low quality of life, functional decline, nursing home placement, and death among older people. The investigators have found that sleep disturbance is common among ADHC patients, it is not addressed within routine clinical care, and treatment is commonly limited to medications (e.g., hypnotics, sedating antidepressants). Numerous studies show that both untreated insomnia and pharmacological treatment of insomnia can be associated with increased risk of falls and other adverse health events among older persons. On the other hand, nonpharmacological interventions on sleep do not show these adverse effects, have been shown to be effective and are associated with improvements in mood, quality of life and health.

The goal of the proposed study is to test the effectiveness of cognitive-behavioral interventions to improve self-reported and objectively-measured sleep quality among older veterans with insomnia in a VA ADHC program. The intervention programs will involve 4-session manualized treatments, plus daily time outdoors to increase exposure to bright light. This Sleep Intervention Program (SIP) will be will be compared with a second program including 4 individual sessions plus daily relaxation practice using a randomized trial with 70 veterans. To our knowledge, this study would be the first to address the unmet need for non-pharmacological treatment of sleep problems among ADHC patients. The intervention design (e.g., use of a manualized treatment that can be provided by non-psychologists) will facilitate translation into routine care and application in other similar VA programs.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
  • Insomnia
  • Sleep Disorders
  • Behavioral: Sleep Intervention Program I
    This program involves behavioral principles plus increased exposure to bright light, delivered in 4 individual sessions carried out within the Adult Day Health Care program.
  • Behavioral: Sleep Intervention Program II
    This program involves behavioral principles plus relaxation exercises, delivered in 4 individual sessions carried out within the Adult Day Health Care program.
  • Experimental: Arm 1
    Individual Behavioral Sleep Intervention Program plus increased light exposure provided within Adult Day Healthcare Program
    Intervention: Behavioral: Sleep Intervention Program I
  • Experimental: Arm 2
    Individual Sleep Education Program plus relaxation practice provided within Adult Day Healthcare Program
    Intervention: Behavioral: Sleep Intervention Program II
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

All of the following:

  • ADHC program participant
  • Age >= 60 years
  • Ability to communicate verbally

Exclusion Criteria:

One or more of the following:

  • Significant cognitive impairment (Mini Mental State Examination score<20)
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01259401
E7037-R
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Jennifer Martin, PhD VA Greater Los Angeles Healthcare System, Sepulveda, CA
Department of Veterans Affairs
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP