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Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04570930
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : November 23, 2020
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Noelle E Carlozzi, University of Michigan

Brief 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.

Condition or disease Intervention/treatment Phase
Caregivers Behavioral: Just-in-time adaptive intervention (JITAI) Behavioral: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This behavioral trial will use a 2-arm randomized controlled design.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Just-in-time adaptive intervention (JITAI)
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.
Behavioral: Just-in-time adaptive intervention (JITAI)
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.

Active Comparator: Control
Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period (without the personalized feedback).
Behavioral: Control
Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period.




Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. Change from baseline in self-reported anxiety score as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety [ Time Frame: Baseline, Day 180 of intervention ]
    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.

  2. Change from baseline in self-reported depression score as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Depression [ Time Frame: Baseline, Day 180 of intervention ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04570930


Contacts
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Contact: Chris Graves 734-764-0644 PMR-CODAlab@med.umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Chris Graves    734-764-0644    PMR-CODAlab@med.umich.edu   
Principal Investigator: Noelle Carlozzi, Ph.D.         
United States, Texas
Baylor College of Medicine Not yet recruiting
Houston, Texas, United States, 77030
Contact: Jay Bogaards    713-797-7102    jay.bogaards@memorialhermann.org   
Principal Investigator: Angelle Sander, Ph.D.         
Sponsors and Collaborators
University of Michigan
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Noelle Carlozzi, Ph.D. University of Michigan
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Responsible Party: Noelle E Carlozzi, Associate Professor of Physical Medicine and Rehabilitation, University of Michigan
ClinicalTrials.gov Identifier: NCT04570930    
Other Study ID Numbers: HUM00181282
2R01NR013658 ( U.S. NIH Grant/Contract )
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: The data will be available after the acceptance for publication of the main findings from the final dataset.
Access Criteria: Data is available upon request to the project manager. Requests for data sharing should be emailed to PMR-CODAlab@med.umich.edu

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Noelle E Carlozzi, University of Michigan:
Stress
Anxiety
Depression
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries