Dementia, MixedREACH HopeNCT04969796
REACH Hope Intervention for Dementia and TBI Caregivers
A study testing REACH Hope in people with Dementia, Mixed and Dementia of Alzheimer Type, run by Memphis VA Medical Center at 1 site in United States.
Trial summary
This three-year randomized clinical trial will evaluate a behavioral intervention for caregivers of Veterans with traumatic brain injury (TBI) and Alzheimer's dementia or mixed Dementia (AD/MD) to reduce caregiver depression, anxiety and burden, and improve veterans' health management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Mixed, Dementia of Alzheimer Type, TBI (Traumatic Brain Injury)
- What is being tested?
- REACH Hope
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2021to 14 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary caregiver for person with diagnosis of TBI and subsequent dementia
- at least one activity of daily living limitation or 2 or more instrumental activity of daily living limitation
- provide 4 or more hours of care per day for at least 6 months
- endorse a score of at least high burden (>8) on the Zarit Burden Inventory-4
Who cannot join
- no mobile telephone or electronic device that can accept the Hope Box application
- current diagnosis of schizophrenia or other major mental illness
- auditory impairment that would make telephone use difficult
Trial locations and contacts
1 site in 1 country.
United States1 site
Caregiver Center, VA Medical Center
Memphis, Tennessee, 38104
About this study
Official title: Supporting Caregivers of Veterans With TBI and Mixed Dementia: The REACH Hope Behavioral Intervention
This three-year randomized clinical trial will evaluate a behavioral intervention for caregivers of Veterans with traumatic brain injury (TBI) and Alzheimer's dementia or mixed Dementia (AD/MD) to reduce caregiver depression, anxiety and burden, and improve veterans' health management. The study will combine and deliver two award-winning behavioral interventions - REACH VA (Resources for Enhancing All Caregivers Health in Department of Veterans Affairs) and the DoD's Virtual Hope Box, which we call REACH Hope. Both REACH and Hope Box have evidence of effectiveness individually but have not been delivered together for caregivers supporting veterans with complex neurodegenerative diagnoses and health conditions. Our primary hypothesis is that REACH Hope will improve caregivers' quality of life as measured by reduced burden.
- Being tested
- REACH Hope
- Medical subject headings
- Mixed Dementias, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REACH HopeOther
REACH VA (Resources for Enhancing All Caregivers Health in Department of Veterans Affairs) and the DoD's Virtual Hope Box. For REACH Hope, as the caregiver and interventionist work on strategies one-on-one, these will be integrated into the Hope Box for the caregiver to use between and after sessions.
| Study group | Role | What they receive |
|---|---|---|
| REACH Hope | Experimental | Participants receive the REACH behavioral intervention coupled with the Department of Defense Hope Box app. Receives: Other: REACH Hope |
| Wait list control | Active comparator | Participants receive the REACH behavioral intervention coupled with the Department of Defense Hope Box app. Receives: Other: REACH Hope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Burden at three months
Measured by the Zarit Burden Inventory- 12
Measured: three months
Change from baseline Burden at six months
Measured by the Zarit Burden Inventory- 12
Measured: six months
Secondary outcomes (6)
Change from baseline Depression at three months
As measured with the Patient Health Questionnaire-9
Measured: Three months
Change from baseline Depression at six months
As measured with the Patient Health Questionnaire-9
Measured: Six months
Change from baseline Anxiety at three months
As measured with the General Anxiety Disorders-7
Measured: Three months
Change from baseline Anxiety at six months
As measured with the General Anxiety Disorders-7
Measured: six months
Change from baseline Caregiving self-efficacy at three months
As measured with the Caregiving Self-Efficacy scale
Measured: three months
Change from baseline Caregiving self-efficacy at six months
As measured with the Caregiving Self-Efficacy scale
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start2 Feb 2021
- Primary completion1 Aug 2023 (estimated)
- Study completion14 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dementia, MixedStudies of the same condition, open and under way.
- 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
- Model description
- The study is a wait list control design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memphis VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Virginia Commonwealth University, University of Tennessee
- Responsible party
- Sponsor
- Investigators
- Linda O Nichols, PhD, Principal investigator, US Department of Veterans AffairsPaul Perrin, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969796
- Sponsor's protocol ID
- AZ190094
- Acronym
- REACH Hope
- Status last verified
- Mar 2023
- First submitted
- 1 Jul 2021
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nichols LO, Martindale-Adams J, Seel RT, Zuber JK, Perera R, Perrin PB. Reducing burden and anxiety for caregivers of veterans with traumatic brain injury and dementia: Randomized controlled trial of the resources for enhancing all caregivers' health-Hope intervention. Rehabil Psychol. 2026 Aug;71(3):383-394. doi: 10.1037/rep0000632. Epub 2025 Jul 31.
PubMed 40742769
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Caregivers of Veterans With TBI and Mixed Dementia: The REACH Hope Behavioral Intervention
- ClinicalTrials.gov ID
- NCT04969796
- Acronym / sponsor ID
- REACH Hope / AZ190094
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Memphis VA Medical CenterUS federal agency
- Collaborators
- Virginia Commonwealth University, University of Tennessee
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 14 Aug 2023 (estimated)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This three-year randomized clinical trial will evaluate a behavioral intervention for caregivers of Veterans with traumatic brain injury (TBI) and Alzheimer's dementia or mixed Dementia (AD/MD) to reduce caregiver depression, anxiety and burden, and improve veterans' health management. The study will combine and deliver two award-winning behavioral interventions - REACH VA (Resources for Enhancing All Caregivers Health in Department of Veterans Affairs) and the DoD's Virtual Hope Box, which we call REACH Hope. Both REACH and Hope Box have evidence of effectiveness individually but have not been delivered together for caregivers supporting veterans with complex neurodegenerative diagnoses and health conditions. Our primary hypothesis is that REACH Hope will improve caregivers' quality of life as measured by reduced burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a wait list control design.
| Arm | Type | Receives |
|---|---|---|
| REACH Hope | Experimental | Other: REACH HopeParticipants receive the REACH behavioral intervention coupled with the Department of Defense Hope Box app. |
| Wait list control | Active comparator | Other: REACH HopeParticipants receive the REACH behavioral intervention coupled with the Department of Defense Hope Box app. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- primary caregiver for person with diagnosis of TBI and subsequent dementia
- at least one activity of daily living limitation or 2 or more instrumental activity of daily living limitation
- provide 4 or more hours of care per day for at least 6 months
- endorse a score of at least high burden (>8) on the Zarit Burden Inventory-4
Key exclusion criteria (3 listed)
- no mobile telephone or electronic device that can accept the Hope Box application
- current diagnosis of schizophrenia or other major mental illness
- auditory impairment that would make telephone use difficult
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 |
|---|---|---|
| REACH HopeREACH VA (Resources for Enhancing All Caregivers Health in Department of Veterans Affairs) and the DoD's Virtual Hope Box. For REACH Hope, as the caregiver and interventionist work on strategies one-on-one, these will be integrated into the Hope Box for the caregiver to use between and after sessions. | Other | REACH Hope, Wait list control |
Primary outcome
Change from baseline Burden at three months
Time frame: three months
Measured by the Zarit Burden Inventory- 12
Change from baseline Burden at six months
Time frame: six months
Measured by the Zarit Burden Inventory- 12
6 secondary outcomes
Change from baseline Depression at three months
Time frame: Three months
Change from baseline Depression at six months
Time frame: Six months
Change from baseline Anxiety at three months
Time frame: Three months
Change from baseline Anxiety at six months
Time frame: six months
Change from baseline Caregiving self-efficacy at three months
Time frame: three months
Change from baseline Caregiving self-efficacy at six months
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Derived from this study: PubMed 40742769Nichols LO, Martindale-Adams J, Seel RT, Zuber JK, Perera R, Perrin PB. Reducing burden and anxiety for caregivers of veterans with traumatic brain injury and dementia: Randomized controlled trial of the resources for enhancing all caregivers' health-Hope intervention. Rehabil Psychol. 2026 Aug;71(3):383-394. doi: 10.1037/rep0000632. Epub 2025 Jul 31.
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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.
Linda O Nichols, PhD principal investigator
US Department of Veterans Affairs
Paul Perrin, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REACH Hope in people with Dementia, Mixed and Dementia of Alzheimer Type, run by Memphis VA Medical Center 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 3 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: status not confirmed, as of the sponsor's last update on 10 Mar 2023. 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?
Results are not available in the source record.
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?
Change from baseline Burden at three months (time frame: three months). 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 NCT04969796, which also lists 1 linked publication.
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 10 Mar 2023.