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Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury

Primary Purpose

Caregivers

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Just-in-time adaptive intervention (JITAI)

Control

About this trial

This is an interventional treatment trial for Caregivers focused on measuring Stress, Anxiety, Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Michigan
Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Just-in-time adaptive intervention (JITAI)

Control

Arm Description

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.

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

Outcomes

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

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

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.

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.

Full Information

NCT ID

NCT04570930

First Posted

September 25, 2020

Last Updated

September 6, 2023

Sponsor

University of Michigan

Collaborators

National Institute of Nursing Research (NINR)

1. Study Identification

Unique Protocol Identification Number

NCT04570930

Brief Title

Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury

Official Title

Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

December 9, 2020 (Actual)

Primary Completion Date

August 19, 2023 (Actual)

Study Completion Date

August 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Caregivers

Keywords

Stress, Anxiety, Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This behavioral trial will use a 2-arm randomized controlled design.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

257 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Just-in-time adaptive intervention (JITAI)

Arm Type

Experimental

Arm Description

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.

Arm Title

Control

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Just-in-time adaptive intervention (JITAI)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Control

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, Day 180 of intervention

Secondary Outcome Measure Information:

Title

Change from baseline in self-reported anxiety score as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety

Description

Time Frame

Baseline, Day 180 of intervention

Title

Change from baseline in self-reported depression score as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Depression

Description

Time Frame

Baseline, Day 180 of intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Noelle Carlozzi, Ph.D.

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Baylor College of Medicine

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing Time Frame

The data will be available after the acceptance for publication of the main findings from the final dataset.

IPD Sharing Access Criteria

Data is available upon request to the project manager. Requests for data sharing should be emailed to PMR-CODAlab@med.umich.edu

Citations:

PubMed Identifier

35679283

Citation

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.

Results Reference

derived

Learn more about this trial

Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury

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