Just-in-time Adaptive Feedback Systems to Assist Individuals With Spinal Cord Injury
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The objective of this study is to develop algorithms that incorporate each individual's
      automatically detected physical activity (PA) level and a clinician's PA level recommendation
      to provide a smartphone application that helps a person set safe and highly personalized PA
      goals. By adapting the goals in real-time based on the person's actual behavior, the system
      aims to keep the individual feeling positive and motivated towards a change in the PA
      behavior.
    

Detailed description: 
      Lack of regular physical activity (PA) in the general population is a top public health
      concern, and this problem is even more acute among individuals with spinal cord injury (SCI).
      Research has shown that only a small percentage (<20%) of persons with SCI reported
      consistent PA. Individuals with SCI also experience secondary conditions such as pain,
      fatigue, weight gain, and deconditioning, conditions that are considered preventable through
      PA and exercise interventions.

      The objective of this proposed study is to develop algorithms that incorporate each
      individual's PA level and a clinician's PA level recommendation to provide a mobile phone
      application that helps a person set PA goals that are safe, but also highly personalized. By
      adapting the goals in real-time based on the person's actual behavior, the system aims to
      keep the individual feeling positive and motivated.

      Aim 1: Extend and utilize Physical Activity Monitor System (PAMS) to track PA levels,
      sedentary behavior, and secondary conditions such as pain, fatigue, and deconditioning in
      community settings.

      Aim 2: Extend and utilize PAMS to passively monitor PA and provide continuous, but passive
      feedback about PA levels to individuals with SCI in community settings.

      Aim 3: Extend and utilize PAMS to passively monitor PA and provide just-in-time persuasive
      and adaptive feedback to motivate individuals with SCI in community settings.

      Sample size: A total of 20 individuals with SCI will take part in the study. The sample size
      for this pilot study is based on budget constraints and other pilot studies. This study will
      provide the pilot data required to compute the power for future studies.

      Statistical Analysis: Univariate analysis will be performed to obtain a range of values and
      the central tendency for variables such as PA levels and sedentary behaviors. Sedentary
      behavior will be assessed by the time duration of non-movement of individuals with SCI and
      not just the total duration of being seated in their wheelchairs.

      The investigators hypothesize that the PA level of individuals with SCI in community will be
      low compared to the PA level recommendations for individuals with disabilities in general.
      Furthermore, the sedentary behavior of individuals with SCI will be high compared to the
      general population.

      Multiple regression analysis will be performed to assess a relationship between secondary
      conditions such as pain (scores), fatigue (scores), and deconditioning (reduced capacity
      scores) and PA levels. The investigators postulate that secondary conditions will be
      negatively correlated with the PA levels.

      Repeated measures general linear model (GLM) analysis will be performed to assess the change
      in PA levels, sedentary behaviors and secondary conditions. In addition, linear mixed model
      analysis will be performed to develop a personal intercept (and maybe slope) for each
      participant compared to the mean intercept for each group. Mixed effects model analysis will
      provide correct estimates of intervention (passive feedback and just-in-time adaptive
      feedback) and other fixed effects (within-subjects factor) in the presence of correlated data
      (each participant at different time points) that arise from a data hierarchy (group).
      Non-parametric tests will be performed if the assumptions for parametric tests are not met.
    

Intervention name(s): Passive feedback and JITAI
Intervention type(s): Behavioral
Intervention description(s): Second Phase - PA Level Feedback
A PA recommendation handout based on PA guidelines for individuals with SCI will be provided. Participants continue to use the same sensing equipment as in phase one (baseline). The equipment consists of a smartwatch, a smartphone, and a wheel rotation monitor. Participants can view their feedback whenever they want, but will not be prompted with the information.
Third Phase - PA Level Feedback and Just-in-time Adaptive Intervention (JITAI)
The third phase of the study will be similar to the second phase of the study, but with an additional JITAI component. The JITAI component of the study will include providing proactively-prompted, real-time feedback through the smartphone and smartwatch when the participant performs a bout of moderate PA.
Intervention model: Single Group Assignment
Intervention model description: Each individual will take part in the study for three phases, each with a duration of one month. The first month will involve collecting baseline PA levels. The second and third months of the study will provide the participants with passive PA level feedback and just-in-time persuasive feedback about their PA levels, respectively.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Spinal Cord Injuries; Physical Activity; Mobile-health; Just-in-time-adaptive intervention; Real-time feedback