Skip to content

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

Designing and Evaluating a Comprehensive Support Program for Families Caring for Relatives Living With TBI-AD/ADRD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05465109
Acronym
TACSI
Enrollment
95
Registered
2022-07-19
Start date
2022-07-01
Completion date
2025-06-28
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregiver Burden, Caregiver Burnout, Caregiver Stress Syndrome

Keywords

Caregiver, Traumatic brain injury, Alzheimer's, Dementia

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.

Interventions

OTHERTBI-AD/ADRD Caregiver Support Intervention (TACSI)

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.

Sponsors

United States Department of Defense
CollaboratorFED
Minneapolis Veterans Affairs Medical Center
CollaboratorFED
Mayo Clinic
CollaboratorOTHER
Congressionally Directed Medical Research Programs
CollaboratorFED
University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Caregiver primary subjective stress- Phase 1change in score from baseline to 3 monthsChange in score from baseline to Module 6
Caregiver primary subjective stress- Phase 2, 3mochange in score from baseline to 3 monthsChange in score from baseline to Module 6
Caregiver primary subjective stress- Phase 2, 6mochange in score from baseline to 6 monthsChange in score from baseline to Module 6

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026