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

Sponsor
University of Minnesota (Other)
Overall Status
Recruiting
CT.gov ID
NCT05465109
Collaborator
United States Department of Defense (U.S. Fed), Minneapolis Veterans Affairs Medical Center (U.S. Fed), Mayo Clinic (Other)
95
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2
24
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: TBI-AD/ADRD Caregiver Support Intervention (TACSI)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
95 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Designing and Evaluating a Comprehensive Support Program for Families Caring for Relatives Living With TBI-AD/ADRD
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: TACSI

Other: TBI-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.

No Intervention: Usual care control group

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.

Outcome Measures

Primary Outcome Measures

  1. Caregiver primary subjective stress- Phase 1 [change in score from baseline to 3 months]

    Change in score from baseline to Module 6

  2. Caregiver primary subjective stress- Phase 2, 3mo [change in score from baseline to 3 months]

    Change in score from baseline to Module 6

  3. Caregiver primary subjective stress- Phase 2, 6mo [change in score from baseline to 6 months]

    Change in score from baseline to Module 6

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Minnesota Minneapolis Minnesota United States 55455

Sponsors and Collaborators

  • University of Minnesota
  • United States Department of Defense
  • Minneapolis Veterans Affairs Medical Center
  • Mayo Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT05465109
Other Study ID Numbers:
  • STUDY00014886
First Posted:
Jul 19, 2022
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Minnesota
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 10, 2022