Clinical trial NCT01259401: Treating Sleep Problems in VA Adult Day Health Care
Official title: Treating Sleep Problems in VA Adult Day Health Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Sleep Disorders
Keywords: Sleep
Rehabilitation
Behavior therapy
Insomnia
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-12-14
Enrollment: 72
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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 study was to test the effectiveness of a cognitive-behavioral intervention to improve self-reported and objectively-measured sleep quality among older veterans with insomnia in a VA ADHC program. The intervention program involved a 4-session manualized treatment. This Sleep Intervention Program (SIP) was compared to an active Sleep Education control that also included 4 individual sessions using a randomized trial with 72 veterans. To our knowledge, this study is 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Sleep Efficiency
timeFrame: End of 4-week intervention
measure: Sleep Efficiency
timeFrame: 4-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Sepulveda
country: United States
facility: VA Greater Los Angeles Healthcare System, Sepulveda, CA
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, Sepulveda, CA
name: Jennifer Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.