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Just-in-time adaptive intervention (JITAI) for Caregiver

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

Study Summary

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

Eligible Conditions

Caregiver

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, day 180 of intervention

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in self-reported caregiver strain as measured by Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) Caregiver Strain

Secondary outcome measures

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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Nursing Research (NINR)NIH

579 Previous Clinical Trials

10,376,125 Total Patients Enrolled

University of MichiganLead Sponsor

1,794 Previous Clinical Trials

6,373,659 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: Control, Just-in-time adaptive intervention (JITAI)

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for participation in this research endeavor?

"Affirmative. Clinicaltrials.gov houses information which shows that this experiment, first posted on December 9th 2020, is actively accepting applicants. There are 240 potential participants being sought from 2 different clinical sites."

Answered by AI

To what extent are individuals participating in this medical experiment?

"Affirmative, the information hosted on clinicaltrials.gov suggests that this medical study is currently in need of participants. The trial was first unveiled on December 9th 2020 and recently updated on August 4th 2022. There are 240 patients needed to be enrolled from two different healthcare facilities."

Answered by AI

Recent research and studies

Plos OneJournal

Improving Outcomes for Care Partners of Persons with Traumatic Brain Injury: Protocol for a Randomized Control Trial of a Just-in-time-adaptive Self-management Intervention

Carlozzi, Noelle E., Angelle M. Sander, Sung Won Choi, Zhenke Wu, Jennifer A. Miner, Angela K. Lyden, Christopher Graves, and Srijan Sen. 2022. “Improving Outcomes for Care Partners of Persons with Traumatic Brain Injury: Protocol for a Randomized Control Trial of a Just-in-time-adaptive Self-management Intervention”. Edited by Lorena Verduci. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0268726.

clinicaltrials.govStudy

Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury

Noelle E Carlozzi 2020. "Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04570930.