Caregiver BurdenTACSINCT05465109
Traumatic Brain Injury and Alzheimer's Disease/Related Dementias Caregiver Support Intervention
A study testing TBI-AD/ADRD Caregiver Support Intervention (TACSI) in people with Caregiver Burden and Caregiver Stress Syndrome, run by University of Minnesota at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden, Caregiver Stress Syndrome, Caregiver Burnout
- What is being tested?
- TBI-AD/ADRD Caregiver Support Intervention (TACSI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 28 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Designing and Evaluating a Comprehensive Support Program for Families Caring for Relatives Living With TBI-AD/ADRD
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.
- Being tested
- TBI-AD/ADRD Caregiver Support Intervention (TACSI)
- Keywords
- Caregiver, Traumatic brain injury, Alzheimer's, Dementia
- Medical subject headings
- Caregiver Burden, Brain Injuries, Traumatic, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBI-AD/ADRD Caregiver Support Intervention (TACSI)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| TACSI | Experimental | Not described Receives: Other: TBI-AD/ADRD Caregiver Support Intervention (TACSI) |
| Usual care control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Caregiver primary subjective stress- Phase 1
Change in score from baseline to Module 6
Measured: change in score from baseline to 3 months
Caregiver primary subjective stress- Phase 2, 3mo
Change in score from baseline to Module 6
Measured: change in score from baseline to 3 months
Caregiver primary subjective stress- Phase 2, 6mo
Change in score from baseline to Module 6
Measured: change in score from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Jul 2022
- Primary completion28 Jun 2025
- Study completion28 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Minneapolis Veterans Affairs Medical Center, Mayo Clinic, Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465109
- Sponsor's protocol ID
- STUDY00014886
- Other IDs
- CDMRP-AZ200106
- Acronym
- TACSI
- Status last verified
- Dec 2025
- First submitted
- 15 Jul 2022
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ostenso S, Birkeland RW, Albers E, Louwagie KW, Iwan A, Chesak SS, Gaugler JE. The TBI-AD/ADRD Caregiver Support Intervention (TACSI): Protocol of a Pilot Randomized Controlled Trial Evaluation of a Remote Intervention for Family Caregivers. JMIR Res Protoc. 2026 Mar 17;15:e81125. doi: 10.2196/81125.
PubMed 41843801
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing and Evaluating a Comprehensive Support Program for Families Caring for Relatives Living With TBI-AD/ADRD
- ClinicalTrials.gov ID
- NCT05465109
- Acronym / sponsor ID
- TACSI / STUDY00014886
- Keywords
- Caregiver, Traumatic brain injury, Alzheimer's, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- United States Department of Defense, Minneapolis Veterans Affairs Medical Center, Mayo Clinic, Congressionally Directed Medical Research Programs
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 28 Jun 2025 (actual)
- Study completion
- 28 Jun 2025 (actual)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACSI | Experimental | Other: TBI-AD/ADRD Caregiver Support Intervention (TACSI) |
| Usual care control group | No intervention | –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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | TACSI |
Primary outcome
Caregiver primary subjective stress- Phase 1
Time frame: change in score from baseline to 3 months
Change in score from baseline to Module 6
Caregiver primary subjective stress- Phase 2, 3mo
Time frame: change in score from baseline to 3 months
Change in score from baseline to Module 6
Caregiver primary subjective stress- Phase 2, 6mo
Time frame: change in score from baseline to 6 months
Change in score from baseline to Module 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Derived from this study: PubMed 41843801Ostenso S, Birkeland RW, Albers E, Louwagie KW, Iwan A, Chesak SS, Gaugler JE. The TBI-AD/ADRD Caregiver Support Intervention (TACSI): Protocol of a Pilot Randomized Controlled Trial Evaluation of a Remote Intervention for Family Caregivers. JMIR Res Protoc. 2026 Mar 17;15:e81125. doi: 10.2196/81125.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TBI-AD/ADRD Caregiver Support Intervention (TACSI) in people with Caregiver Burden and Caregiver Stress Syndrome, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver primary subjective stress- Phase 1 (time frame: change in score from baseline to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05465109, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.