Support intervention for caregivers of individuals with traumatic brain injury and dementia
Designing and Evaluating a Comprehensive Support Program for Families Caring for Relatives Living With TBI-AD/ADRD
NA · University of Minnesota · NCT05465109
This study tests a support program for caregivers of loved ones with both traumatic brain injury and dementia to see if it helps them cope better with their challenges.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 95 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of Minnesota (other) |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05465109 on ClinicalTrials.gov |
What this trial studies
The TBI-AD/ADRD Caregiver Support Intervention (TACSI) aims to assist caregivers of individuals diagnosed with both traumatic brain injury and dementia. This intervention combines psychosocial and psychoeducational methods to identify stressors faced by caregivers and to help them develop effective coping strategies and improve their caregiving self-efficacy. Caregivers will receive support tailored to their unique challenges, enhancing their ability to manage the demands of caregiving. The program is designed for caregivers who are the primary support for their loved ones, ensuring they have the necessary resources to cope with their responsibilities.
Who should consider this trial
Good fit: Ideal candidates for this study are caregivers aged 21 and older who provide primary support for individuals with both traumatic brain injury and dementia.
Not a fit: Patients who are not caregivers or those who do not have a dual diagnosis of traumatic brain injury and dementia may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce caregiver stress and improve the quality of life for both caregivers and care recipients.
How similar studies have performed: Previous studies have shown that caregiver support interventions can be effective, suggesting that this approach may yield positive outcomes as well.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Study coordinator: Joseph E. Gaugler, PhD
- Email: gaug0015@umn.edu
- Phone: 612-626-2485
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Caregiver Burden, Caregiver Stress Syndrome, Caregiver Burnout, Caregiver, Traumatic brain injury, Alzheimer's, Dementia