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CaregiversNCT04570930

Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury

A study testing Just-in-time adaptive intervention (JITAI) in people with Caregivers, run by University of Michigan at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Care partners of persons with traumatic brain injury (TBI) are often faced with considerable physical and emotional stress resulting from their caregiver role. The researchers hypothesize that the care partners who receive the intervention will show improvements in caregiver strain and mental health. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Caregivers
What is being tested?
Just-in-time adaptive intervention (JITAI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
257 participants
Where
2 sitesUnited States
Study dates
9 Dec 2020to 19 Aug 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Be caring for an adult (age 18 or above) with a medically documented TBI that is ≥1-year post-injury and meets the TBI Model Systems (TBIMS) criteria for complicated mild, moderate or severe TBI and who sustained their TBI at age 16 or older
  • Provide emotional, physical, and/or financial support/assistance to the individual with the TBI, indicating a response ≥1 to the following question: "On a scale of 0-10, where 0 is "no assistance" and 10 is "assistance with all activities", how much assistance does the person you care for require from you to complete activities of daily living due to problems resulting from his/her TBI? Activities could consist of personal hygiene, dressing and undressing, housework, taking medications, managing money, running errands, shopping for groceries or clothing, transportation, meal preparation and cleanup, remembering things, etc."
  • Have access to necessary resources for participating in a technology-based intervention (smartphone/tablet and internet access) and be willing to use their personal equipment/internet for this study, including downloading the study app and the Fitbit® app on their mobile device
  • Is able and willing to complete all study assessments for the duration of their study participation (approximately 375 days)

Who cannot join

  • Is a professional, paid caregiver (e.g., home health aide)
  • Anything that would preclude safe or meaningful participation in the study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Baylor College of Medicine

    Houston, Texas, 77030

Other trials in United States

About this study

Care partners of persons with traumatic brain injury (TBI) are often faced with considerable physical and emotional stress resulting from their caregiver role. The researchers hypothesize that the care partners who receive the intervention will show improvements in caregiver strain and mental health.

Conditions
Caregivers
Being tested
Just-in-time adaptive intervention (JITAI), Control
Keywords
Stress, Anxiety, Depression
Medical subject headings
Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Just-in-time adaptive intervention (JITAI)Behavioural

    JITAI is an emerging intervention that incorporates passive mobile sensor data feedback (sleep and activity [step] data from a Fitbit ®), and real-time self-reporting of HRQOL via a study specific app called CareQOL to provide personalized feedback via app alert.

  • ControlBehavioural

    Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period.

Study groups in NCT04570930
Study groupRoleWhat they receive
Just-in-time adaptive intervention (JITAI)ExperimentalParticipants 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.
Receives: Behavioral: Just-in-time adaptive intervention (JITAI)
ControlActive comparatorParticipants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period (without the personalized feedback).
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Self-reported Caregiver Strain as Measured by Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) Caregiver Strain

    TBI-CareQOL Caregiver Strain assesses perceived feelings of feeling overwhelmed, stressed and "beat-down" related to the care partner role. Self-reported responses are on a Likert scale. The measure is scored on a T metric with a mean of 50 and a standard deviation of 10. Higher scores indicate more strain.

    Measured: Baseline, Day 180 of intervention

Secondary outcomes (2)

  1. Change From Baseline in Self-reported Anxiety Score as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety

    PROMIS Anxiety assesses self-reported feelings of fear, anxiety and hyper-arousal. Self-reported responses are on a Likert scale. The measure is scored on a T metric with a mean of 50 and a standard deviation of 10. Higher scores indicate more anxiety.

    Measured: Baseline, Day 180 of intervention

  2. Change From Baseline in Self-reported Depression Score as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Depression

    PROMIS Depression assesses self-reported feelings of sadness and worthlessness. Self-reported responses are on a Likert scale. The measure is scored on a T metric with a mean of 50 and a standard deviation of 10. Higher scores indicate more depression.

    Measured: Baseline, Day 180 of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2020
  2. Study start9 Dec 2020
  3. Primary completion19 Aug 2023
  4. Study completion19 Aug 2023

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This behavioral trial will use a 2-arm randomized controlled design.
Masking
None (open label)
Enrolment
257 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04570930
Sponsor's protocol ID
HUM00181282
Other IDs
2R01NR013658
Status last verified
Sep 2024
First submitted
25 Sep 2020
Last updated
19 Sep 2024
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Participant data collected during the trial, after de-identification, will be available for sharing with individuals in the scientific community, upon request. The data will be available after the acceptance for publication of the main findings from the final dataset. The University of Michigan Project Manager will coordinate requests for data and maintain documentation for requests and distributions. An institutional data use agreement will be required before data is shared.

Publications

  • Fansher M, Fauser AT, Troost JP, Miner JA, Graves CM, Sander AM, Carlozzi NE. Understanding sleep-related quality of life in caregivers of people with traumatic brain injury. Rehabil Psychol. 2026 Oct 5. doi: 10.1037/rep0000691. Online ahead of print.

    PubMed 42831842

  • Wang J, Wu Z, Sander AM, Sen S, Choi SW, Miner JA, Graves C, Carlozzi NE. Understanding the impact of perceived app usability on the efficacy of mobile health intervention for traumatic brain injury caregivers. Rehabil Psychol. 2026 May 4:10.1037/rep0000674. doi: 10.1037/rep0000674. Online ahead of print.

    PubMed 42080899

  • Carlozzi NE, Troost J, Lombard WL, Miner JA, Graves CM, Choi SW, Wu Z, Sen S, Sander AM. Completion and Compliance Rates for an Intensive mHealth Study Design to Promote Self-Awareness and Self-Care Among Care Partners of Individuals With Traumatic Brain Injury: Secondary Analysis of a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Aug 21;13:e73772. doi: 10.2196/73772.

    PubMed 40840460

  • Carlozzi NE, Choi SW, Wu Z, Sen S, Troost J, Lyden AK, Miner JA, Graves C, Sander AM. The reliability and validity of the TBI-CareQOL system in four diverse caregiver groups. J Patient Rep Outcomes. 2023 Jun 26;7(1):57. doi: 10.1186/s41687-023-00602-x.

    PubMed 37358716

  • Carlozzi NE, Sander AM, Choi SW, Wu Z, Miner JA, Lyden AK, Graves C, Sen S. 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. PLoS One. 2022 Jun 9;17(6):e0268726. doi: 10.1371/journal.pone.0268726. eCollection 2022.

    PubMed 35679283

Questions about this trial

What is this clinical trial studying?

A study testing Just-in-time adaptive intervention (JITAI) in people with Caregivers, run by University of Michigan at 2 sites 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 4 inclusion and 2 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Self-reported Caregiver Strain as Measured by Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) Caregiver Strain (time frame: Baseline, Day 180 of intervention). 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 NCT04570930, which also lists 5 linked publications.

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 19 Sep 2024.

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