Treating Sleep Problems in VA Adult Day Health Care (HERO-ADHC)
Primary Purpose
Insomnia, Sleep Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep Intervention Program
Sleep Education control
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Sleep, Rehabilitation, Behavior therapy, Insomnia
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)
Sites / Locations
- VA Greater Los Angeles Healthcare System, Sepulveda, CA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SIP group
Control group
Arm 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.
The Control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care
Outcomes
Primary Outcome Measures
Sleep Efficiency
Percentage of time asleep while in bed estimated by actigraphy
Sleep Efficiency
Percentage of time asleep while in bed estimated by actigraphy.
Secondary Outcome Measures
Full Information
NCT ID
NCT01259401
First Posted
December 10, 2010
Last Updated
January 6, 2015
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT01259401
Brief Title
Treating Sleep Problems in VA Adult Day Health Care
Acronym
HERO-ADHC
Official Title
Treating Sleep Problems in VA Adult Day Health Care
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Sleep Disorders
Keywords
Sleep, Rehabilitation, Behavior therapy, Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SIP group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The Control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care
Intervention Type
Behavioral
Intervention Name(s)
Sleep Intervention Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Education control
Intervention Description
During sessions, participants reviewed two educational brochures that focused on changes in sleep with age and sleep hygiene education.
Primary Outcome Measure Information:
Title
Sleep Efficiency
Description
Percentage of time asleep while in bed estimated by actigraphy
Time Frame
End of 4-week intervention
Title
Sleep Efficiency
Description
Percentage of time asleep while in bed estimated by actigraphy.
Time Frame
4-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Martin, PhD
Organizational Affiliation
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, Sepulveda, CA
City
Sepulveda
State/Province
California
ZIP/Postal Code
91343
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28482053
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.
Results Reference
derived
Learn more about this trial
Treating Sleep Problems in VA Adult Day Health Care
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