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Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury

N/A
Waitlist Available
Led By Noelle Carlozzi, Ph.D.
Research Sponsored by University of Michigan
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 baseline, day 180 of intervention
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether an intervention can help improve caregivers' strain and mental health.

Eligible Conditions
  • Caregiver

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 180 of intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 180 of intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Self-reported Caregiver Strain as Measured by Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) Caregiver Strain
Secondary study objectives
Change From Baseline in Self-reported Anxiety Score as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety
Change From Baseline in Self-reported Depression Score as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Depression

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Just-in-time adaptive intervention (JITAI)Experimental Treatment1 Intervention
Participants will wear the Fitbit®, provide daily reports of Health- Related Quality of Life (HRQOL) and receive personalized pushes over a six-month (180 day) period.
Group II: ControlActive Control1 Intervention
Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period (without the personalized feedback).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Just-in-time adaptive intervention (JITAI)
2020
N/A
~330

Find a Location

Who is running the clinical trial?

National Institute of Nursing Research (NINR)NIH
604 Previous Clinical Trials
10,378,144 Total Patients Enrolled
University of MichiganLead Sponsor
1,861 Previous Clinical Trials
6,440,780 Total Patients Enrolled
Noelle Carlozzi, Ph.D.Principal InvestigatorUniversity of Michigan

Media Library

Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04570930 — N/A
Caregiver Research Study Groups: Just-in-time adaptive intervention (JITAI), Control
Caregiver Clinical Trial 2023: Intervention Highlights & Side Effects. Trial Name: NCT04570930 — N/A
Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04570930 — N/A
~51 spots leftby Dec 2025
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