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

Study Overview
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Brief Summary
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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.

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

Conditions
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Caregiver Burden, Caregiver Stress Syndrome, Caregiver Burnout

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TACSI<br> | Other: TBI-AD/ADRD Caregiver Support Intervention (TACSI)<br>* 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.<br>|
| No Intervention: Usual care control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregiver, Traumatic brain injury, Alzheimer's, Dementia