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
  Purpose

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.


Condition Intervention
Insomnia
Sleep Disorders
Behavioral: Sleep Intervention Program I
Behavioral: Sleep Intervention Program II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Sleep Problems in VA Adult Day Health Care

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 83
Study Start Date: November 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Individual Behavioral Sleep Intervention Program plus increased light exposure provided within Adult Day Healthcare Program
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.
Experimental: Arm 2
Individual Sleep Education Program plus relaxation practice provided within Adult Day Healthcare 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.

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 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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259401

Locations
United States, California
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, United States, 91343
Sponsors and Collaborators
Investigators
Principal Investigator: Jennifer Martin, PhD VA Greater Los Angeles Healthcare System, Sepulveda, CA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01259401     History of Changes
Other Study ID Numbers: E7037-R
Study First Received: December 10, 2010
Last Updated: September 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Sleep
Rehabilitation
Behavior therapy
Insomnia

Additional relevant MeSH terms:
Dyssomnias
Parasomnias
Sleep Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014