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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIP group | Experimental | 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. |
|
| Control group | Active Comparator | The Control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Intervention Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Efficiency | Percentage of time asleep while in bed estimated by actigraphy | End of 4-week intervention |
| Sleep Efficiency | Percentage of time asleep while in bed estimated by actigraphy. | 4-month follow-up |
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Inclusion Criteria:
All of the following:
Exclusion Criteria:
One or more of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Martin, PhD | VA Greater Los Angeles Healthcare System, Sepulveda, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, Sepulveda, CA | Sepulveda | California | 91343 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26200520 | Result | 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. | |
| 28482053 | Derived |
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A total of 72 participants were enrolled into the study. After baseline assessment, 30 participants were not eligible for randomization: too cognitive impaired to participate (13); medical or behavioral issue (n=6); no longer met criteria for insomnia (n=3); discharged from ADHC (n=4); refused randomization (n=2); withdrew (n=2).
Veterans enrolled in the ADHC program for at least one month were screened for study eligibility criteria (i.e., the ability to understand screening items and to communicate during the screening process. If the individual was interested, written informed consent was obtained.
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| ID | Title | Description |
|---|---|---|
| FG000 | SIP Group | The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program. 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. |
| FG001 | Control Group | The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| End of 4-week Intervention |
| |||||||||||||
| 4-month Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SIP Group | The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sleep Efficiency | Percentage of time asleep while in bed estimated by actigraphy | Two SIP subjects had missing data for this variable. | Posted | Mean | 95% Confidence Interval | percentage of time in bed spent asleep | End of 4-week intervention |
|
Four months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SIP Group | The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wrist abrasion from actigraph | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Small sample size; predominantly male study sample
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Martin | VA Greater Los Angeles Healthcare System | 818 891-7711 | 9173 | Jennifer.Martin@va.gov |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| Sleep Education control | Behavioral | During sessions, participants reviewed two educational brochures that focused on changes in sleep with age and sleep hygiene education. |
|
| 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. |
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| BG001 | Control Group | The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education. |
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| Primary | Sleep Efficiency | Percentage of time asleep while in bed estimated by actigraphy. | Two SIP subjects had missing data for this variable. | Posted | Mean | 95% Confidence Interval | percentage of time in bed asleep | 4-month follow-up |
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| 0 |
| 21 |
| 1 |
| 21 |
| EG001 | Control Group | The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education. | 0 | 21 | 1 | 21 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |