REACH Hope Intervention for Dementia and TBI Caregivers

NCT04969796 | Unknown

• 1 other identifier: AZ190094
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Change from baseline Burden at three months

  Measured by the Zarit Burden Inventory- 12

  three months

• Change from baseline Burden at six months

  Measured by the Zarit Burden Inventory- 12

  six months

Secondary Outcomes (6)

• Change from baseline Depression at three months

  Three months

• Change from baseline Depression at six months

  Six months

• Change from baseline Anxiety at three months

  Three months

• Change from baseline Anxiety at six months

  six months

• Change from baseline Caregiving self-efficacy at three months

  three months

Study Arms (2)

REACH Hope

EXPERIMENTAL

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

Other: REACH Hope

Wait list control

ACTIVE COMPARATOR

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

Other: REACH Hope

Interventions

REACH Hope OTHER

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.

REACH Hope; Wait list control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memphis VA Medical Center: lead
• Virginia Commonwealth University: collaborator
• University of Tennessee: collaborator

Study Sites (1)

Caregiver Center, VA Medical Center

Memphis, Tennessee, 38104, United States

Location

Related Publications (1)

• 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. 2025 Jul 31:10.1037/rep0000632. doi: 10.1037/rep0000632. Online ahead of print.

  PMID: 40742769 DERIVED

MeSH Terms

Conditions

Mixed Dementias; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Linda O Nichols, PhD

  US Department of Veterans Affairs

  PRINCIPAL INVESTIGATOR

• Paul Perrin, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The study is a wait list control design.

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 21, 2021
• Study Start: February 2, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 14, 2023
• Last Updated: March 10, 2023

Record last verified: 2023-03

Locations

US (1)