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Caregiver Support Intervention for Caregiver Stress Syndrome (TACSI Trial)
N/A
Recruiting
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in score from baseline to 6 months
Awards & highlights
TACSI Trial Summary
This trial looks at a new intervention to help caregivers of people with both traumatic brain injury and dementia. The intervention includes helping caregivers identify stressors and developing better coping and communication strategies.
Who is the study for?
This trial is for caregivers over 21 years old in the U.S. who primarily assist a family member with both traumatic brain injury and dementia, are English-speaking, willing to participate, and not receiving similar psychosocial support elsewhere. Caregivers must be stable on any psychotropic medications for three months.Check my eligibility
What is being tested?
The TACSI program is being tested to help caregivers of individuals with traumatic brain injury and dementia. It aims to identify caregiving stressors and teach effective coping, communication skills, and improve confidence in caregiving abilities.See study design
What are the potential side effects?
Since TACSI is a supportive educational intervention rather than a medication or medical procedure, it does not have physical side effects but may bring emotional discomfort as sensitive topics are discussed.
TACSI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in score from baseline to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in score from baseline to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Caregiver primary subjective stress- Phase 1
Caregiver primary subjective stress- Phase 2, 3mo
Caregiver primary subjective stress- Phase 2, 6mo
TACSI Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TACSIExperimental Treatment1 Intervention
Group II: Usual care control groupActive Control1 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.
Find a Location
Who is running the clinical trial?
Minneapolis Veterans Affairs Medical CenterFED
72 Previous Clinical Trials
14,825 Total Patients Enrolled
Mayo ClinicOTHER
3,208 Previous Clinical Trials
3,766,955 Total Patients Enrolled
1 Trials studying Caregiver Burden
60 Patients Enrolled for Caregiver Burden
University of MinnesotaLead Sponsor
1,379 Previous Clinical Trials
1,588,397 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to take part in the TACSI evaluation.My caregiver speaks English.I have been diagnosed with both traumatic brain injury and Alzheimer's or related dementia.My caregiver is at least 21 years old.I am a caregiver with a new or worsening mental health issue and not on stable medication.I am the primary or one of the main caregivers for someone with cognitive impairments due to TBI-AD/ADRD.
Research Study Groups:
This trial has the following groups:- Group 1: TACSI
- Group 2: Usual care control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have signed up to partake in this experiment?
"Affirmative. The clinicaltrials.gov registry demonstrates that this investigation is actively recruiting subjects, with its first post-date being July 1st 2022 and most recent update on August 5th 2022. Ninety five participants are sought after from a single site."
Answered by AI
Is there room for more participants in this research?
"Affirmative. The clinicaltrials.gov website displays that this research is still recruiting applicants, with 95 participants sought from 1 site since it was first publicised on July 1st 2022 and updated last on August 5th 2022."
Answered by AI
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