This study will investigate the effect of a low-cost, multi-component, individualized, and adaptive telehealth program on (1) adherence to exercise guidelines by community-dwelling adults with spinal cord injury (SCI) and (2) on improving health and functional outcomes categorized by the World Health Organization's International Classification of Functioning, Disability and Health (ICF) model.
The proposed trial consists of three phases:
Phase 1: Technology Development (not a clinical trial)
Participants with SCI, caregivers, and clinicians
Aim 1: Obtain input from consumers on the modifications needed to customize smartphone-based apps to assess and facilitate exercise adherence.
With input from consumers and clinicians during in-person and remote focus groups, the investigators will gain information that can be used to develop and modify exercise and health monitoring apps to optimize usability and compliance. The investigators will ask a group of "expert" clinicians and researchers that are knowledgeable about SCI to identify the most important constructs to discuss during the focus groups. The focus groups will include various app stakeholders (individuals with SCI, caregivers, clinicians) to ensure diverse perspectives from all potential app users.
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Phase 2: Usability Testing (not a clinical trial)
Participants with SCI only
Aim 2: Conduct a usability study of custom apps to optimize their acceptability, appropriateness, and feasibility.
The investigators will assess the acceptability, appropriateness, and feasibility of the customized exercise app in persons with SCI, and determine the quality (i.e., engagement, functionality, aesthetics, information quality, and perceived benefits) of these apps. From usability metrics collected after participants with SCI completed a two-week trial using the app, the investigators can implement further changes to further optimize the app.
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Phase 3: Two-Stage SMART Trial (clinical trial)
Participants with SCI only
Aim 3: Conduct a proof-of-concept sequential multiple assignment randomized trial (SMART) study to determine the most effective adaptive interventions to improve exercise adherence and health and functional outcomes.
In Stage-I, the investigators will compare the effect of using (Group 1) commercially available, free to use, non-interactive smartphone health apps (a simplified version of Pt Pal) vs. (Group 2) a personalized, interactive app (Pt Pal), which allows for customizations for each individual. While both groups will be provided customized exercises at the beginning of the intervention, only those in Group 2 will get regular (i.e., bi-weekly/monthly) exercise updates based on their progress and Ecological Momentary Assessments (EMA) monitoring throughout Stage-I (weeks 1-12). In Stage-II (weeks 13-24), e-coaching will be added for participants who do not achieve at least 50% guideline adherence using these app-based interventions in Stage-I. The investigators will randomize participants who are not adherent to the exercise guidelines to either twice per month (Groups 1a/2a) or four times per month (Groups 1b/2b) e-coaching that utilizes SCI-specific EMA and motivational interviewing techniques. E-coaching in real-time using trained personnel will augment the initial intervention to support coping with barriers and action planning. Outcomes will be reassessed at the end of Stage-I (12 weeks) and Stage-II (24 weeks).
Aim 3.1: Compare effects of two app-based interventions on primary and secondary outcomes: Group 1 (customized exercise + non-interactive app) vs. Group 2 (customized exercise + interactive, customized app).
Aim 3.2: Compare effects of two augmented interventions on primary and secondary outcomes: Groups 1a and 2a (e-coaching twice per month) vs. Groups 1b and 2b (e-coaching four times per month).
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Exploratory Phase: (not a clinical trial)
Participants with SCI, caregivers, and clinicians
Exploratory Aim: Explore exercise protocols, questionnaire delivery, sensor types/setups, sensor parameters, and/or analysis techniques to optimally capture psychosocial, mobility, and other characteristics.
As needed, the investigators may trial variations of the questionnaires, sensors, and other parameters using to optimize the data collection procedures for Phases 1-3.
