Back to resultsTraumatic Brain Injury and Alzheimer's Disease/Related Dementias Caregiver Support Intervention (TACSI)
Primary Purpose
Caregiver Burden, Caregiver Stress Syndrome, Caregiver Burnout
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TBI-AD/ADRD Caregiver Support Intervention (TACSI)
Sponsored by
About this trial
This is an interventional supportive care trial for Caregiver Burden focused on measuring Caregiver, Traumatic brain injury, Alzheimer's, Dementia
Eligibility Criteria
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.
Sites / Locations
- University of MinnesotaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
TACSI
Usual care control group
Arm 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.
Outcomes
Primary Outcome Measures
Caregiver primary subjective stress- Phase 1
Change in score from baseline to Module 6
Caregiver primary subjective stress- Phase 2, 3mo
Change in score from baseline to Module 6
Caregiver primary subjective stress- Phase 2, 6mo
Change in score from baseline to Module 6
Secondary Outcome Measures
Full Information
NCT ID
NCT05465109
First Posted
July 15, 2022
Last Updated
August 9, 2023
Sponsor
University of Minnesota
Collaborators
United States Department of Defense, Minneapolis Veterans Affairs Medical Center, Mayo Clinic
1. Study Identification
Unique Protocol Identification Number
NCT05465109
Brief Title
Traumatic Brain Injury and Alzheimer's Disease/Related Dementias Caregiver Support Intervention
Acronym
TACSI
Official Title
Designing and Evaluating a Comprehensive Support Program for Families Caring for Relatives Living With TBI-AD/ADRD
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
United States Department of Defense, Minneapolis Veterans Affairs Medical Center, Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burden, Caregiver Stress Syndrome, Caregiver Burnout
Keywords
Caregiver, Traumatic brain injury, Alzheimer's, Dementia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
95 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TACSI
Arm Type
Experimental
Arm Title
Usual care control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
TBI-AD/ADRD Caregiver Support Intervention (TACSI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Caregiver primary subjective stress- Phase 1
Description
Change in score from baseline to Module 6
Time Frame
change in score from baseline to 3 months
Title
Caregiver primary subjective stress- Phase 2, 3mo
Description
Change in score from baseline to Module 6
Time Frame
change in score from baseline to 3 months
Title
Caregiver primary subjective stress- Phase 2, 6mo
Description
Change in score from baseline to Module 6
Time Frame
change in score from baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph E. Gaugler, PhD
Phone
612-626-2485
Email
gaug0015@umn.edu
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Gaugler, PhD
Phone
612-626-2485
Email
gaug0015@umn.edu
12. IPD Sharing Statement
Learn more about this trial
Traumatic Brain Injury and Alzheimer's Disease/Related Dementias Caregiver Support Intervention
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