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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 : December 11, 2020
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Noelle E Carlozzi, University of Michigan

Tracking Information
First Submitted Date  ICMJE September 25, 2020
First Posted Date  ICMJE September 30, 2020
Last Update Posted Date December 11, 2020
Actual Study Start Date  ICMJE December 9, 2020
Estimated Primary Completion Date May 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2020)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury
Official Title  ICMJE Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Caregivers
Intervention  ICMJE
  • 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.
  • Behavioral: Control
    Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Just-in-time adaptive intervention (JITAI)
  • 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).
    Intervention: Behavioral: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 25, 2020)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2025
Estimated Primary Completion Date May 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Chris Graves 734-764-0644 PMR-CODAlab@med.umich.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04570930
Other Study ID Numbers  ICMJE HUM00181282
2R01NR013658 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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
Responsible Party Noelle E Carlozzi, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: Noelle Carlozzi, Ph.D. University of Michigan
PRS Account University of Michigan
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP