DementiaVACARESNCT02106065
VA Cultivating Access to Resources, Education, and Skills for Dementia Caregivers
A study testing Education and Skill-Building Rehabilitation (ESBR) and Supplemental Education Materials in people with Dementia and Caregivers, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is to study the effects of an education and skill-building intervention on family caregivers of Veterans with dementia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Caregivers, Neurodegenerative Diseases
- What is being tested?
- Education and Skill-Building Rehabilitation (ESBR) and Supplemental Education Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2014to 30 Sep 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be adults (age 18)
- report distress associated with being the primary caregiver for a Veteran family member with all-cause dementia
- reporting at least 2 of the following 6 items at baseline assessment: felt overwhelmed, felt like they often needed to cry, were angry or frustrated, felt they were cut off from family or friends, reported moderate to high levels of general stress, or felt their health had declined
- provide at least one hour of care (supervision or direct assistance) per week over the past 3 months (other sources of caregiving for the Veteran with dementia can also be utilized; e.g., respite, home health aide, other family members, etc.)
- be proficient in spoken and written English
- be capable of providing informed consent
Who cannot join
- Exclusion criteria -- Potential participants will be screened and excluded for:
- current or lifetime history of any psychiatric disorder with psychotic features
- prominent suicidal or homicidal ideation
- having met DSM-IV criteria for drug or alcohol abuse or dependence (except nicotine) within the past six months
- presence of alcohol intoxication (by breathalyzer) or alcohol withdrawal (by exam) during study recruitment or participation
- diagnosis of probable or possible dementia
Show all 11Show fewer
- a Telephone Cognitive Screen score of < 20
- participation in another caregiver intervention within the past year
- lack of regular access to a telephone
- illness that would prevent 24 months of study participation
- planned transfer of care receiver to another caregiver or nursing home within 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
About this study
Official title: Dementia Caregiver Rehabilitation: Enhancing Veteran and Family-Centered Care
The purpose of this study is to study the effects of an education and skill-building intervention on family caregivers of Veterans with dementia.
Read the detailed description
According to VA estimates, nearly 500,000 Veterans suffer from dementia. There is currently no cure for dementia. Ultimately, dementia will have a large impact on quality of life in Veterans and families, lead to expensive nursing home placement, and decrease life expectancy for patients and family caregivers. The experience of high burden in a caregiver for a Veteran with dementia increases the likelihood of permanent nursing home placement and can separate Veterans from their families. To address the high burden of caring for a Veteran with dementia, the investigators aim to study the effect of a rehabilitative intervention for family caregivers of Veterans with dementia. This novel approach will use video technology that can reach caregivers in rural areas who do not have easy access to major VA medical centers.
- Conditions
- Dementia, Caregivers, Neurodegenerative Diseases, Brain Diseases
- Being tested
- Education and Skill-Building Rehabilitation (ESBR), Supplemental Education Materials
- Keywords
- Dementia, Caregivers, Neurodegenerative Diseases, Brain Diseases, Cost of Illness, Stress, Psychological, Depression, Vital Statistics, Mortality, Behavioral Symptoms, Residential Facilities, Emergency Medical Services, Long-Term Care
- Medical subject headings
- Dementia, Neurodegenerative Diseases, Brain Diseases, Stress, Psychological, Depression, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and Skill-Building Rehabilitation (ESBR)Behavioural
Also called ESBR
ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS.
Supplemental Education MaterialsOther
Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia.
| Study group | Role | What they receive |
|---|---|---|
| In-person Education and Skill-Building Rehabilitation (ESBR-i) Condition | Experimental | Education and Skill-Building Rehabilitation delivered in clinic Receives: Behavioral: Education and Skill-Building Rehabilitation (ESBR) |
| Education and Skill-Building Rehabilitation over Video (ESBR-V) Condition | Experimental | Education and Skill-Building Rehabilitation delivered via video telehealth. Receives: Behavioral: Education and Skill-Building Rehabilitation (ESBR) |
| Usual Care Condition | Active comparator | Usual Care plus supplemental paper education materials Receives: Other: Supplemental Education Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zarit Burden Inventory
The Zarit Burden Inventory is a self-report measure of caregiver burden. Higher scores on this assessment indicate greater levels of caregiver burden. Potential scores range from 0-88 with higher scores indicating more severe burden.
Measured: change from baseline at 6-months post intervention
Secondary outcomes (3)
Center for Epidemiological Studies-Depression
change in caregiver depressive symptoms as measured by the Center for Epidemiological Studies-Depression (CES-D). Scores on the CES-D can range from 0-60 with higher scores suggesting greater depressive symptomatology.
Measured: change from baseline at 6-months
Long-term Care Placement Status (Care Recipient)
Based on caregiver interview, permanent placement of the care recipient in LTC will be ascertained
Measured: 6-months post intervention
Change in All-cause Mortality Status (Care Recipient)
Based on caregiver interview, care recipient mortality status will be ascertained
Measured: 6-months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study start21 Feb 2014
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
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.
- Other trials for DementiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Blake K Scanlon, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CAJennifer K Fairchild, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106065
- Sponsor's protocol ID
- E1240-W
- Other IDs
- 5IK2RX001240-02
- Acronym
- VACARES
- Status last verified
- Jul 2021
- First submitted
- 27 Mar 2014
- Last updated
- 13 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dementia Caregiver Rehabilitation: Enhancing Veteran and Family-Centered Care
- ClinicalTrials.gov ID
- NCT02106065
- Acronym / sponsor ID
- VACARES / E1240-W
- Conditions
- Dementia, Caregivers, Neurodegenerative Diseases, Brain Diseases
- Keywords
- Dementia, Caregivers, Neurodegenerative Diseases, Brain Diseases, Cost of Illness, Stress, Psychological, Depression, Vital Statistics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 21 Feb 2014 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 7 Apr 2014 (estimated)
- Results
- Posted 13 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study the effects of an education and skill-building intervention on family caregivers of Veterans with dementia.
Detailed description
According to VA estimates, nearly 500,000 Veterans suffer from dementia. There is currently no cure for dementia. Ultimately, dementia will have a large impact on quality of life in Veterans and families, lead to expensive nursing home placement, and decrease life expectancy for patients and family caregivers. The experience of high burden in a caregiver for a Veteran with dementia increases the likelihood of permanent nursing home placement and can separate Veterans from their families. To address the high burden of caring for a Veteran with dementia, the investigators aim to study the effect of a rehabilitative intervention for family caregivers of Veterans with dementia. This novel approach will use video technology that can reach caregivers in rural areas who do not have easy access to major VA medical centers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In-person Education and Skill-Building Rehabilitation (ESBR-i) Condition | Experimental | Behavioral: Education and Skill-Building Rehabilitation (ESBR)Education and Skill-Building Rehabilitation delivered in clinic |
| Education and Skill-Building Rehabilitation over Video (ESBR-V) Condition | Experimental | Behavioral: Education and Skill-Building Rehabilitation (ESBR)Education and Skill-Building Rehabilitation delivered via video telehealth. |
| Usual Care Condition | Active comparator | Other: Supplemental Education MaterialsUsual Care plus supplemental paper education materials |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- be adults (age 18)
- report distress associated with being the primary caregiver for a Veteran family member with all-cause dementia
- reporting at least 2 of the following 6 items at baseline assessment: felt overwhelmed, felt like they often needed to cry, were angry or frustrated, felt they were cut off from family or friends, reported moderate to high levels of general stress, or felt their health had declined
- provide at least one hour of care (supervision or direct assistance) per week over the past 3 months (other sources of caregiving for the Veteran with dementia can also be utilized; e.g., respite, home health aide, other family members, etc.)
- be proficient in spoken and written English
Key exclusion criteria (11 listed)
- current or lifetime history of any psychiatric disorder with psychotic features
- prominent suicidal or homicidal ideation
- having met DSM-IV criteria for drug or alcohol abuse or dependence (except nicotine) within the past six months
- presence of alcohol intoxication (by breathalyzer) or alcohol withdrawal (by exam) during study recruitment or participation
- diagnosis of probable or possible dementia
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 |
|---|---|---|
| Education and Skill-Building Rehabilitation (ESBR)Also: ESBRESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS. | Behavioural | Education and Skill-Building Rehabilitation over Video (ESBR-V) Condition, In-person Education and Skill-Building Rehabilitation (ESBR-i) Condition |
| Supplemental Education MaterialsParticipants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia. | Other | Usual Care Condition |
Primary outcome
Zarit Burden Inventory
Time frame: change from baseline at 6-months post intervention
The Zarit Burden Inventory is a self-report measure of caregiver burden. Higher scores on this assessment indicate greater levels of caregiver burden. Potential scores range from 0-88 with higher scores indicating more severe burden.
3 secondary outcomes
Center for Epidemiological Studies-Depression
Time frame: change from baseline at 6-months
Long-term Care Placement Status (Care Recipient)
Time frame: 6-months post intervention
Change in All-cause Mortality Status (Care Recipient)
Time frame: 6-months post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Blake K Scanlon, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
Jennifer K Fairchild, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, 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 Education and Skill-Building Rehabilitation (ESBR) and Supplemental Education Materials in people with Dementia and Caregivers, 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 6 inclusion and 11 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 13 Aug 2021. 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 13 Aug 2021). 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?
Zarit Burden Inventory (time frame: change from baseline at 6-months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2021.