Traumatic Brain Injury and Alzheimer's Disease/Related Dementias Caregiver Support Intervention
NCT ID: NCT05465109
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
95 participants
INTERVENTIONAL
2022-07-01
2025-06-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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TACSI
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
21 Years
ALL
Yes
Sponsors
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United States Department of Defense
FED
Minneapolis Veterans Affairs Medical Center
FED
Mayo Clinic
OTHER
Congressionally Directed Medical Research Programs
FED
University of Minnesota
OTHER
Responsible Party
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Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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STUDY00014886
Identifier Type: -
Identifier Source: org_study_id
CDMRP-AZ200106
Identifier Type: OTHER
Identifier Source: secondary_id