Treating Sleep Problems in VA Adult Day Health Care (HERO-ADHC)
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|ClinicalTrials.gov Identifier: NCT01259401|
Recruitment Status : Completed
First Posted : December 14, 2010
Results First Posted : December 30, 2014
Last Update Posted : January 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Insomnia Sleep Disorders||Behavioral: Sleep Intervention Program Behavioral: Sleep Education control||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Treating Sleep Problems in VA Adult Day Health Care|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Experimental: SIP group
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
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.
Active Comparator: Control group
The Control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care
Behavioral: Sleep Education control
During sessions, participants reviewed two educational brochures that focused on changes in sleep with age and sleep hygiene education.
- Sleep Efficiency [ Time Frame: End of 4-week intervention ]Percentage of time asleep while in bed estimated by actigraphy
- Sleep Efficiency [ Time Frame: 4-month follow-up ]Percentage of time asleep while in bed estimated by actigraphy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259401
|United States, California|
|VA Greater Los Angeles Healthcare System, Sepulveda, CA|
|Sepulveda, California, United States, 91343|
|Principal Investigator:||Jennifer Martin, PhD||VA Greater Los Angeles Healthcare System, Sepulveda, CA|