Mobile Technology and Data Analytics to Identify Real-time Predictors of Caregiver Well-Being

Study Overview
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Brief Summary
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The purpose of this study is to test whether personalized messages from an easy-to-use mobile app improve mood and stress among care partners and to see if care partners like using the app.

Official Title
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Mobile Technology and Data Analytics to Identify Real-time Predictors of Caregiver Well-Being

Conditions
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Caregivers

Intervention / Treatment
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* Behavioral: Just-in-time adaptive intervention (JITAI)
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Care Partner Inclusion Criteria: Provide emotional, physical, and/or financial support/assistance to an individual with spinal cord injury (SCI), Huntington's Disease (HD), or hematopoietic cell transplantation (HCT) 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 Care partners of persons with HD: Be caring for an adult (18 years or older) with a clinical diagnosis of HD Care partners of persons with SCI: Be caring for an adult (18 years or older) that is ≥1 post-injury and sustained a medically documented SCI at age 16 or older Care partners of persons with HCT: Be caring for an adult (18 years or older) who is receiving, has received or is scheduled to receive HCT Exclusion Criteria: Is a professional, paid caregiver (e.g., home health aide)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This behavioral trial will use a two-arm randomized controlled design.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Participants will wear the Fitbit® and provide daily reports of health related quality of life (HRQOL) over a three-month (90 day) period (without the personalized feedback). | Behavioral: Control<br>* Participants will wear the Fitbit® and provide daily reports of HRQOL over a three-month (90 day) period<br>|
| Experimental: Just-in-time adaptive intervention (JITAI)<br>Participants will wear the Fitbit®, provide daily reports of health related quality of life (HRQOL) and receive personalized pushes over a three-month (90 day) period. | Behavioral: Just-in-time adaptive intervention (JITAI)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire | Items are scaled from 1 to 5 to indicate the level of agreement, where 1 indicates strong disagreement and 5 indicates strong agreement. Percentages shown are the combined percentage of participants who selected agree or strongly agree or their equivalent (as labeled). | 3 months of wearing the Fitbit and completing the surveys | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attrition as Measured by the Percent of Participants Completing the Study |  | 3 months of wearing the Fitbit and completing the surveys | 
| Adherence as Measured by the Percentage of Contributed Data Over the Course of the Study | Contributed data percentages are shown by caregiver group (HD, SCI, HCT) for daily surveys, daily steps, daily sleep, calculated by number of days of data provided divided by number of total possible days that it could be provided. | 3 months of wearing the Fitbit and completing the surveys | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Insomnia, Stress related disorders, Anxiety