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

Caregiver Burden Clinical Trial

— TACSI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05465109
• Other study ID #: STUDY00014886
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: University of Minnesota
• Contact: Joseph E. Gaugler, PhD
• Phone: 612-626-2485
• Email: gaug0015[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caregiver Burden
• Caregiver Burnout
• Caregiver Stress Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
University of Minnesota	Mayo Clinic, Minneapolis Veterans Affairs Medical Center, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caregiver primary subjective stress- Phase 1	Change in score from baseline to Module 6	change in score from baseline to 3 months
Primary	Caregiver primary subjective stress- Phase 2, 3mo	Change in score from baseline to Module 6	change in score from baseline to 3 months
Primary	Caregiver primary subjective stress- Phase 2, 6mo	Change in score from baseline to Module 6	change in score from baseline to 6 months