Traumatic Brain Injury and Alzheimer's Disease/Related Dementias Caregiver Support Intervention

NCT05465109 | Completed

• 2 other identifiers: STUDY00014886CDMRP-AZ200106
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

The TBI-AD/ADRD Caregiver Support Intervention (TACSI) incorporates psychosocial and psychoeducational approaches with the objective of: a) identifying stressors associated with caregiving for family members who have the dual diagnosis of traumatic brain injury and dementia; and b) supporting caregivers in developing more effective coping and communication strategies as well as enhanced caregiving self-efficacy.

Conditions

Caregiver Burden; Caregiver Stress Syndrome; Caregiver Burnout

Keywords

Caregiver; Traumatic brain injury; Alzheimer's; Dementia

Outcome Measures

Primary Outcomes (3)

• Caregiver primary subjective stress- Phase 1

  Change in score from baseline to Module 6

  change in score from baseline to 3 months

• Caregiver primary subjective stress- Phase 2, 3mo

  Change in score from baseline to Module 6

  change in score from baseline to 3 months

• Caregiver primary subjective stress- Phase 2, 6mo

  Change in score from baseline to Module 6

  change in score from baseline to 6 months

Study Arms (2)

TACSI

EXPERIMENTAL

Other: TBI-AD/ADRD Caregiver Support Intervention (TACSI)

Usual care control group

NO INTERVENTION

The usual care control group would have continued receipt of standard services at either the Mayo Clinic or the MVAHCS. In addition, staff will offer participants the opportunity to request supportive/educational resources as needed after randomization.

Interventions

TBI-AD/ADRD Caregiver Support Intervention (TACSI) OTHER

The TBI-AD/ADRD Caregiver Support Intervention (TACSI) incorporates psychosocial and psychoeducational approaches with the objective of: a) identifying stressors associated with caregiving for family members who have the dual diagnosis of traumatic brain injury and dementia; and b) supporting caregivers in developing more effective coping and communication strategies as well as enhanced caregiving self-efficacy. This intervention offers individual and family coaching and knowledge and skills to help manage stress and reduce caregiver burden.

TACSI

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the care recipient has a physician diagnosis of TBI and AD/ADRD (i.e., those with a diagnosis of both TBI and progressive cognitive decline)
• the caregiver self-identifies as someone who provides the most help/is most responsible for the person with TBI-AD/ADRD because of their cognitive impairments (or shares the role equally with another caregiver)
• the caregiver indicates a willingness to participate in the TACSI evaluation
• the caregiver is English speaking
• the caregiver is 21 years of age or older
• the caregiver is not currently participating in any other type of service that provides one-to-one psychosocial consultation or caregiver coaching (peer mentorship/support group participation/general counseling not specific to caregiving is not a deterrent to enrollment) at the discretion of the UMN research team
• the caregiver resides in the US.

You may not qualify if:

• caregivers who have a new or worsening mental health condition and are not receiving ongoing treatment. When applicable, if caregivers have not remained on a stable psychotropic medications dosage, such as antidepressants, anxiolytics or anti-psychotics, for the prior three months they will be excluded.

Sponsors & Collaborators

• University of Minnesota: lead
• Mayo Clinic: collaborator
• Congressionally Directed Medical Research Programs: collaborator
• United States Department of Defense: collaborator
• Minneapolis Veterans Affairs Medical Center: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Caregiver Burden; Brain Injuries, Traumatic; Dementia

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurocognitive Disorders; Mental Disorders

Study Design

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

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 19, 2022
• Study Start: July 1, 2022
• Primary Completion: June 28, 2025
• Study Completion: June 28, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (1)