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

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Enrolling

Conditions

Caregiver Burnout
Caregiver Burden
Caregiver Stress Syndrome

Treatments

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

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT05465109
STUDY00014886

Details and patient eligibility

About

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.

Enrollment

95 estimated patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

95 participants in 2 patient groups

TACSI
Experimental group
Treatment:
Other: TBI-AD/ADRD Caregiver Support Intervention (TACSI)
Usual care control group
No Intervention group
Description:
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.

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Joseph E. Gaugler, PhD

Data sourced from clinicaltrials.gov

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