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Status unknownNCT04969796REACH HopeUpdated Mar 10, 2023

REACH Hope Intervention for Dementia and TBI Caregivers

An interventional study of REACH Hope in Dementia, Mixed, Dementia of Alzheimer Type and TBI (Traumatic Brain Injury), sponsored by Memphis VA Medical Center. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-10.

Sponsored by Memphis VA Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Feb 2021, registered Jul 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Dementia, Mixed
  • Dementia of Alzheimer Type
  • TBI (Traumatic Brain Injury)
03

In context

Mixed Dementias

56 studies on the registry are indexed under Mixed Dementias; 15 are open to participants now.

This study's enrollment of 110 is above the median of 94 across 41 interventional studies indexed under Mixed Dementias.

Browse Mixed Dementias studies →

Lead sponsor

Memphis VA Medical Center is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    REACH Hope

    Participants receive the REACH behavioral intervention coupled with the Department of Defense Hope Box app.

    Other: REACH Hope

  • Active comparator
    Wait list control

    Participants receive the REACH behavioral intervention coupled with the Department of Defense Hope Box app.

    Other: REACH Hope

Interventions

  • OtherREACH Hope

    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.

06

What researchers measure

Primary outcomes

  1. Change from baseline Burden at three months

    Measured by the Zarit Burden Inventory- 12

    Time frame: three months

  2. Change from baseline Burden at six months

    Measured by the Zarit Burden Inventory- 12

    Time frame: six months

Secondary outcomes

  1. Change from baseline Depression at three months

    As measured with the Patient Health Questionnaire-9

    Time frame: Three months

  2. Change from baseline Depression at six months

    As measured with the Patient Health Questionnaire-9

    Time frame: Six months

  3. Change from baseline Anxiety at three months

    As measured with the General Anxiety Disorders-7

    Time frame: Three months

  4. Change from baseline Anxiety at six months

    As measured with the General Anxiety Disorders-7

    Time frame: six months

  5. Change from baseline Caregiving self-efficacy at three months

    As measured with the Caregiving Self-Efficacy scale

    Time frame: three months

  6. Change from baseline Caregiving self-efficacy at six months

    As measured with the Caregiving Self-Efficacy scale

    Time frame: six months

07

Study locations

1 site
  • Caregiver Center, VA Medical Center
    Memphis, Tennessee 38104, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2021 (actual). Primary completion is estimated for Aug 2023, 29 months after the start.

Of 27 interventional studies with no phase under Mixed Dementias, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 40. This study's planned 29 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 1, 2021
First posted
Jul 21, 2021
StartActual
Feb 2, 2021
Primary completionEst.
Aug 1, 2023
CompletionEst.
Aug 14, 2023
Last update
Mar 10, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04969796
Lead sponsor
Memphis VA Medical Center
Collaborators
Virginia Commonwealth University, University of Tennessee
Responsible party
Sponsor
First posted
Jul 21, 2021
Start date
Feb 2, 2021
Primary completion
Aug 1, 2023 (estimated)
Completion
Aug 14, 2023 (estimated)
Last update
Mar 10, 2023

Study contacts

Linda O Nichols, PhD
principal investigator · US Department of Veterans Affairs
Paul Perrin, PhD
principal investigator · Virginia Commonwealth University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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