Care partners of persons with moderate to severe traumatic brain injury (TBI) are often required to assume a caregiver role, bearing primary responsibility for assisting the person with TBI in physical, mental, financial, and leisure activities. As a result of these new caregiving responsibilities, it is common for these care partners to report problems with physical, mental, and social health, as well as compromised health-related quality of life (HRQOL). Given that care partners? well-being and functioning affects both their own personal health outcomes, as well as the functional and rehabilitation outcomes of the person with TBI, there is a critical need to develop novel health management interventions to ensure better health outcomes for both members of the TBI care partnership dyad. Therefore, our long-term goal is to improve the health and well-being of these care partners, as well as their ability to provide care to their loved one. Thus, the proposed randomized control trial will examine the efficacy of a just-in-time adaptive intervention (JITAI), or personalized self-management intervention that uses objective mobile sensor data feedback to improve physical activity, sleep, and HRQOL in 240 care partners of persons with TBI. Our primary objectives are to: 1) assess the efficacy of this novel personalized self-management intervention (i.e., JITAI) for preventing the development of adverse symptoms (e.g., mobility, sleep, poor HRQOL); and 2) use data collected from wearables (i.e., the Fitbit Charge) and real-time assessments of HRQOL to identify care partners with the greatest risk for negative physical and mental HRQOL outcomes, as well as the timing for when they are at greatest risk. We expect care partners that are randomized to receive the JITAI will demonstrate improvements in HRQOL, physical activity and sleep relative to controls. We also hypothesize is that objective, data-derived mobile phenotypes can predict risk for adverse caregiver HRQOL. The scientific premise for the proposed research is based on our multidisciplinary team with expertise in caregiver research, evaluation of HRQOL using patient-reported outcomes, clinical trials implementation, expertise in real time assessment of HRQOL, as well as the statistical expertise in high- dimensional statistics and machine learning. Furthermore, the innovation is grounded in the examination of a real-time, real-world, personalized and scalable JITAI designed to improve HRQOL in care partners. Ultimately, this study will allow us to identify care partners at the greatest risk for negative physical and mental health outcomes, and will provide important efficacy data to support the clinical utility of a low cost, low burden self-management intervention to improve HRQOL for care partners of persons with TBI.

Public Health Relevance

Care partners of persons with traumatic brain injury (TBI) are often faced with considerable physical and emotional stress resulting from their caregiver role; not surprisingly, this stress is associated with negative physical and mental health outcomes for both the care partner and the person for whom they provide care. Given this, interventions focused on improving the health-related quality of life (HRQOL) of these care partners will likely have positive downstream effects for the care recipient. The purpose of this study is to examine the efficacy of a personalized self-management intervention designed to promote care partner self-care; this intervention uses physical activity and sleep data collected using a Fitbit and real-time self-reports of HRQOL collected via a mobile phone app, to provide care partners with personalized feedback via app alert four times per week.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Research Project (R01)
Project #
5R01NR013658-07
Application #
10110031
Study Section
Termination was authorized on 9/28/2020. Clinical Management of Patients in Community-based Settings Study Section (CMPC)
Program Officer
Huss, Karen
Project Start
2012-09-27
Project End
2024-11-30
Budget Start
2020-12-01
Budget End
2021-11-30
Support Year
7
Fiscal Year
2021
Total Cost
Indirect Cost
Name
University of Michigan Ann Arbor
Department
Physical Medicine & Rehab
Type
Schools of Medicine
DUNS #
073133571
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109
Carlozzi, Noelle E; Kallen, Michael A; Ianni, Phillip A et al. (2018) The Development of a New Computer-Adaptive Test to Evaluate Strain in Caregivers of Individuals With TBI: TBI-CareQOL Caregiver Strain. Arch Phys Med Rehabil :
Carlozzi, Noelle E; Kallen, Michael A; Sander, Angelle M et al. (2018) The Development of a New Computer Adaptive Test to Evaluate Anxiety in Caregivers of Individuals With Traumatic Brain Injury: TBI-CareQOL Caregiver-Specific Anxiety. Arch Phys Med Rehabil :
Carlozzi, Noelle E; Ianni, Phillip A; Lange, Rael T et al. (2018) Understanding Health-Related Quality of Life of Caregivers of Civilians and Service Members/Veterans With Traumatic Brain Injury: Establishing the Reliability and Validity of PROMIS Social Health Measures. Arch Phys Med Rehabil :
Carlozzi, Noelle E; Hanks, Robin; Lange, Rael T et al. (2018) Understanding Health-related Quality of Life in Caregivers of Civilians and Service Members/Veterans With Traumatic Brain Injury: Establishing the Reliability and Validity of PROMIS Mental Health Measures. Arch Phys Med Rehabil :
Carlozzi, Noelle E; Kallen, Michael A; Ianni, Phillip A et al. (2018) The development of a two new computer adaptive tests to evaluate feelings of loss in caregivers of individuals with traumatic brain injury: TBI-CareQOL Feelings of Loss-Self and Feelings of Loss-Person with Traumatic Brain Injury. Arch Phys Med Rehabil :
Sander, Angelle M; Hanks, Robin A; Ianni, Phillip A et al. (2018) Sociocultural Factors Influencing Caregiver Appraisals Following Traumatic Brain Injury. Arch Phys Med Rehabil :
Carlozzi, Noelle E; Lange, Rael T; French, Louis M et al. (2018) A Latent Content Analysis of Barriers and Supports to Healthcare: Perspectives From Caregivers of Service Members and Veterans With Military-Related Traumatic Brain Injury. J Head Trauma Rehabil 33:342-353
Carlozzi, Noelle E; Lange, Rael T; French, Louis M et al. (2018) Understanding Health-Related Quality of Life in Caregivers of Civilians and Service Members/Veterans With TBI: Reliability and Validity Data for the TBI-CareQOL Measurement System. Arch Phys Med Rehabil :
Carlozzi, Noelle E; Kallen, Michael A; Hanks, Robin et al. (2018) The Development of a New Computer Adaptive Test to Evaluate Feelings of Being Trapped in Caregivers of Individuals With Traumatic Brain Injury: TBI-CareQOL Feeling Trapped Item Bank. Arch Phys Med Rehabil :
Carlozzi, Noelle E; Ianni, Phillip A; Tulsky, David S et al. (2018) Understanding Health-Related Quality of Life in Caregivers of Civilians and Service Members/Veterans With Traumatic Brain Injury: Establishing the Reliability and Validity of PROMIS Fatigue and Sleep Disturbance Item Banks. Arch Phys Med Rehabil :

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