Using Smartphones to Improve Physical Activity Levels of Individuals With Spinal Cord Injury

Study Overview
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Brief Summary
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The overarching goal of this research study is to evaluate a sensor-enabled, just-in-time adaptive intervention (JITAI) strategy to increase and sustain physical activity levels among individuals with spinal cord injury (SCI) in their communities. A primary objective of this study is to evaluate the integration of a JITAI with a web-based physical activity intervention program. We hypothesize that the integration of web-based physical activity intervention program with JITAI will result in significantly higher physical activity levels compared to the standard web-based physical activity intervention program alone. A secondary objective of this study is to extend existing algorithms that use commercial wearable technology to robustly detect physical activity behaviors to facilitate the delivery of tailored just-in-time actionable feedback and physical activity recommendations for individuals with SCI.

Detailed Description
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The integration of the JITAI, which provides feedback and physical activity recommendations due to sensor-based assessments of physical activity, with a standard web-based physical activity intervention program will be tested via a clinical trial. Specifically, individuals with SCI will be randomized to web-based physical activity intervention program (WI) or web-based physical activity intervention program combined with the JITAI (WI + JITAI). Within the WI + JITAI arm, a micro-randomized trial - a clinical trial design for optimizing mobile-Health interventions - will be used to randomize participants several times a day to various types of tailored feedback and physical activity recommendations. Aim 1: Evaluate the efficacy of the WI + JITAI compared to the standard WI alone. We hypothesize that the integration of WI + JITAI will result in significantly higher physical activity levels compared to the standard WI alone. Aim 2: Use a micro-randomized trial design to optimize the delivery of just-in-time physical activity feedback and recommendations in promoting physical activity. Aim 3: Investigate moderators of the effect of WI + JITAI vs. standard WI alone. Moderators will include age, gender, race/ethnicity, level of injury, function, mobility, pain, and fatigue. The proposed study will yield novel insights about JITAIs and JITAIs combined with more traditional, WI programs, which will help researchers design engaging physical activity interventions for individuals with disability in the community that may improve their health and quality of life.

Official Title
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mHealth-based Just-In-Time Adaptive Intervention to Improve Physical Activity Levels of Individuals With Spinal Cord Injury

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Behavioral: WI program
* Behavioral: WI Program Reminder
* Behavioral: JITAI Goal Setting
* Behavioral: JITAI physical activity message
* Other: Notification EMA
* Other: End of day EMA
* Other: Wake up time EMA
* Other: Weekly PA Information
* Other: Daily PA Information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with SCI will be included if they are: 18-75 years of age have a traumatic or non-traumatic SCI (classification of neurological level of injury at cervical level 5 (C5) and below) are at least 6-months post-SCI use a manual or a power wheelchair as their primary means of mobility (>80% of time) can use their arms to exercise show readiness to physical activity as assessed by the Physical Activity Readiness Questionnaire have experience using a smartphone and smartwatch. Exclusion Criteria: Participants will be excluded if they have: any secondary complications that medically restrict their activity in any way such as cardiovascular disease, pressure injuries, contractures, and infections are diagnosed with traumatic brain injury.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The proposed study is a 24-week longitudinal study that will comprise of 2 weeks of baseline physical activity monitoring, 14 weeks of physical activity monitoring and intervention, and 8 weeks of physical activity monitoring to assess physical activity level sustainability. Individuals with SCI will be randomized to a web-based physical activity intervention (WI) program or a WI program combined with the JITAI (WI + JITAI). Within the WI + JITAI arm, a micro-randomized trial - a clinical trial design for optimizing mobile-Health interventions - will be used to randomize participants several times a day to various types of tailored feedback and physical activity recommendations.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Web-based physical activity intervention (WI) program<br>Participants in the WI arm will take part in the WI program (weeks 3 to 16). After the WI program is completed in week 16, the participants will transition to the physical activity sustainability phase which will include participants having continued access to the information provided during the WI program (weeks 17 to 24). | Behavioral: WI program<br>* This 14-week web-based physical activity intervention (WI) program was developed by the National Center on Health, Physical Activity and Disability. The WI program was developed with guidance from literature and practice in health behavior change and internet-based health promotion programming. The content and features of the WI program include motivational resource, updated weekly resources, and customizable features.<br>Behavioral: WI Program Reminder<br>* Participants will be provided with reminders to use the WI program<br>Other: Weekly PA Information<br>* Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the last 7 days.<br>|
| Experimental: Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)<br>Participants in the WI + JITAI arm will take part in the WI program (weeks 3 to 16). After the WI program is completed in week 16, the participants will transition to the physical activity sustainability phase which will include participants having continued access to the information provided during the WI program (weeks 17 to 24). In addition, participants will have access to the JITAI that will provide just-in-time feedback and physical activity recommendations (weeks 3 to 24). The type of the feedback and recommendation messages in the WI + JITAI arm will be delivered using micro-randomization, which involves random selection of intervention components at each possible time of delivery. | Behavioral: WI program<br>* This 14-week web-based physical activity intervention (WI) program was developed by the National Center on Health, Physical Activity and Disability. The WI program was developed with guidance from literature and practice in health behavior change and internet-based health promotion programming. The content and features of the WI program include motivational resource, updated weekly resources, and customizable features.<br>Behavioral: WI Program Reminder<br>* Participants will be provided with reminders to use the WI program<br>Behavioral: JITAI Goal Setting<br>* Participants will be provided with standard, tailored, or no goal for the day. The goal will focus on recommending minutes of moderate-intensity (or higher) physical activity and a reminder to perform strength exercises.<br>Behavioral: JITAI physical activity message<br>* Participants will be provided with minutes of moderate-intensity (or higher) physical activity achieved, minutes of physical activity remaining, or no message.<br>Other: Notification EMA<br>* Participants will be inquired through an ecological momentary assessment (EMA) if they received a JITAI physical activity message.<br>Other: End of day EMA<br>* Participants will be inquired, through an ecological momentary assessment (EMA), if they performed aerobic and/or strength exercises for the day.<br>Other: Wake up time EMA<br>* Participants will be inquired, through an ecological momentary assessment (EMA), about the time they plan to wake up next day. This information will be used to provide a goal setting message for next day.<br>Other: Weekly PA Information<br>* Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the last 7 days.<br>Other: Daily PA Information<br>* Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in moderate-intensity (or higher) physical activity | The change in average duration of moderate-intensity (or higher) physical activity, measured via mobile-health sensor (smartwatch that is part of the just-in-time adaptive intervention system - JITAI), between baseline and WI program. | Baseline (week 2) and WI Program (week 16) | 
| Change in moderate-intensity (or higher) physical activity | The change in average duration of moderate-intensity (or higher) physical activity, measured via mobile-health sensor (smartwatch that is part of the just-in-time adaptive intervention system - JITAI), between baseline and physical activity sustainability. | Baseline (week 2) and physical activity sustainability (week 24) | 
| Self-reported change in moderate-intensity (or higher) physical activity | The change in average duration of moderate-intensity (or higher) physical activity, measured via Physical Activity Recall Assessment for People with Spinal Cord injury (PARA-SCI) survey, between baseline and WI program. | Baseline (week 2) and WI Program (week 16) | 
| Self-reported change in moderate-intensity (or higher) physical activity | The change in average duration of moderate-intensity (or higher) physical activity, measured via Physical Activity Recall Assessment for People with Spinal Cord injury (PARA-SCI) survey, between baseline and physical activity sustainability. | Baseline (week 2) and physical activity sustainability (week 24) | 
| Self-reported change in moderate-intensity (or higher) leisure time physical activity | The change in average duration of moderate-intensity (or higher) physical activity, measured via Leisure Time Physical Activity Questionnaire for People with SCI (LTPAQ-SCI) survey, between baseline and WI program. | Baseline (week 2) and WI program (week 16) | 
| Self-reported change in moderate-intensity (or higher) leisure time physical activity | The change in average duration of moderate-intensity (or higher) physical activity, measured via Leisure Time Physical Activity Questionnaire for People with SCI (LTPAQ-SCI) survey, between baseline and physical activity sustainability. | Baseline (week 2) and physical activity sustainability (week 24) | 
| Change in proximal physical activity | The primary analysis for this study will address the question of whether, on average, the feedback and physical activity recommendations from JITAI will have a proximal effect on minutes of physical activity performed over the next 120 minutes during the WI program among those who are available at the previous randomization decision point. | WI Program (week 2) and WI Program (week 16) | 
| Change in proximal physical activity | The primary analysis for this study will address the question of whether, on average, the feedback and physical activity recommendations from JITAI will have a proximal effect on minutes of physical activity performed over the next 120 minutes during the physical activity sustainability among those who are available at the previous randomization decision point. | Physical activity sustainability (week 17) and Physical activity sustainability (week 24) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level number | The International SCI Pain Basic Data Set Version 2.0 form will allow us to collect the pain level (number) in the participants over the course of the study. | Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24) | 
| Pain level type | The International SCI Pain Basic Data Set Version 2.0 form will allow us to collect the types of pain (nociceptive, neuropathic, and other) in the participants over the course of the study. | Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24) | 
| Fatigue level | The Neuro-QOL Item Bank Version 1.0 Fatigue Short form will allow us to collect fatigue level. | Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord injuries, physical activity, wearable sensors, mobile health, just-in-time adaptive intervention