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

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VA Office of Research and Development

Status

Completed

Conditions

Sleep Disorders
Insomnia

Treatments

Behavioral: Sleep Intervention Program
Behavioral: Sleep Education control

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01259401
E7037-R

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

72 participants in 2 patient groups

SIP group
Experimental group
Description:
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.
Treatment:
Behavioral: Sleep Intervention Program
Control group
Active Comparator group
Description:
The Control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care
Treatment:
Behavioral: Sleep Education control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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