InsomniaHERO-ADHCNCT01259401
Treating Sleep Problems in VA Adult Day Health Care
A study testing Sleep Intervention Program in people with Insomnia and Sleep Disorders, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Insomnia, Sleep Disorders
- What is being tested?
- Sleep Intervention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All of the following:
- ADHC program participant
- Age >= 60 years
- Ability to communicate verbally
Who cannot join
- One or more of the following:
- Significant cognitive impairment (Mini Mental State Examination score<20)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, 91343
About this study
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.
Read the 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.
- Conditions
- Insomnia, Sleep Disorders
- Being tested
- Sleep Intervention Program, Sleep Education control
- Keywords
- Sleep, Rehabilitation, Behavior therapy, Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Intervention ProgramBehavioural
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.
Sleep Education controlBehavioural
During sessions, participants reviewed two educational brochures that focused on changes in sleep with age and sleep hygiene education.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sleep Intervention 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 Receives: Behavioral: Sleep Education control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency
Percentage of time asleep while in bed estimated by actigraphy
Measured: End of 4-week intervention
Sleep Efficiency
Percentage of time asleep while in bed estimated by actigraphy.
Measured: 4-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jennifer Martin, PhD, Principal investigator, VA Greater Los Angeles Healthcare System, Sepulveda, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259401
- Sponsor's protocol ID
- E7037-R
- Acronym
- HERO-ADHC
- Status last verified
- Feb 2025
- First submitted
- 10 Dec 2010
- Last updated
- 25 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 26200520Martin 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.
PubMed 28482053
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Sleep Problems in VA Adult Day Health Care
- ClinicalTrials.gov ID
- NCT01259401
- Acronym / sponsor ID
- HERO-ADHC / E7037-R
- Conditions
- Insomnia, Sleep Disorders
- Keywords
- Sleep, Rehabilitation, Behavior therapy, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Nov 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 14 Dec 2010 (estimated)
- Results
- Posted 30 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIP group | Experimental | Behavioral: Sleep Intervention ProgramThe 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 | Behavioral: Sleep Education controlThe Control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ADHC program participant
- Age >= 60 years
- Ability to communicate verbally
Key exclusion criteria (2 listed)
- Significant cognitive impairment (Mini Mental State Examination score<20)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Intervention ProgramSessions 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. | Behavioural | SIP group |
| Sleep Education controlDuring sessions, participants reviewed two educational brochures that focused on changes in sleep with age and sleep hygiene education. | Behavioural | Control group |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26200520Song 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.
- Derived from this study: PubMed 28482053Martin 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Martin, PhD principal investigator
VA Greater Los Angeles Healthcare System, Sepulveda, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Intervention Program in people with Insomnia and Sleep Disorders, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency (time frame: End of 4-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01259401, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.