NCT05424172

Improving Adherence to Spinal Cord Injury Exercise Guidelines Using Smartphone Technology and E-coaching

Improving Adherence to Spinal Cord Injury Exercise Guidelines Using Smartphone-Based Technology and E-coaching: A Proof-of-Concept SMART-Design Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Shirley Ryan AbilityLab · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this research is to increase physical activity among individuals with a spinal cord injury (SCI) through a customized, interactive smartphone-based health app and e-coaching using three phases: (1) leading focus groups of potential app users and clinicians to gain information regarding health apps preferences for optimal consumer use, (2) conducting a usability study of the customized app to determine the quality and implement further changes for optimization, and (3) conducting a sequential multiple assignment randomized trial (SMART) to determine the most effective adaptive intervention to improve exercise adherence. A SMART trial will be used to determine when and how to adapt dosage, timing, and delivery to increase adherence and address low-response behaviors. In Stage-I, the investigators will compare outcomes among participants using a generic, non-interactive exercise app (Group 1) to a customized, interactive app that can gain information through frequent Ecological Momentary Assessments (EMA) that will be used to modify each participant's exercise programs (Group 2). After 12 weeks, participants who are not meeting the exercise guidelines at least 50% of the time will also be asked to participate in motivational interviewing-based e-coaching either two or four times per month in addition to their originally assigned intervention (Stage-II). By completing these three phases, this project addresses deficiencies in exercise levels and compliance by implementing an individualized exercise prescription, an adaptive intervention for low responders, a way to address barriers to exercise, and a free smartphone app for broad implementation.

Detailed description

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. \--- 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. \--- 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). \--- 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.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
BEHAVIORAL	Stage-I, Group 1: Self monitoring using Non-interactive App	Participants in Group 1 will have minimal features that affect compliance (notifications, rewards, EMA, etc.) and no modifications to their exercise program after initial prescription.
BEHAVIORAL	Stage-I, Group 2: Self monitoring using Interactive App	Participants in Group 2 will use the version of the exercise app that has been modified based on the findings from Phases 1 and 2 of this study. Group 2 will be able to use the full features of the interactive app including notifications, ability to submit videos, and non-synchronous messaging/communicating with the researcher. Additionally, participants in Group 2 will be asked to complete 2-5 EMA-based surveys daily to gain information about the participant's barriers and facilitators to exercise. The information from the EMA questionnaires will be used to progress and modify the exercise program at regular intervals for each participant in Group 2.
BEHAVIORAL	Stage-II, Groups 1a/2a: E-Coaching 1x per month	In addition to the Stage-I assigned app, participants will be asked to complete at least daily EMA questionnaires and e-coaching sessions two times a month throughout Stage-II (weeks 13-24). Participants will only receive the augmented e-coaching intervention if they were not adherent to the exercise guidelines for at least 50% of the weeks during Stage-I (weeks 1-12).
BEHAVIORAL	Stage-II, Groups 1b/2b: E-Coaching 2x per month	In addition to the Stage-I assigned app, participants will be asked to complete at least daily EMA questionnaires and e-coaching sessions four times a month throughout Stage-II (weeks 13-24). Participants will only receive the augmented e-coaching intervention if they were not adherent to the exercise guidelines for at least 50% of the weeks during Stage-I (weeks 1-12).

Timeline

• Start date: 2022-11-02
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2022-06-21
• Last updated: 2025-04-20

Locations

1 site across 1 country: United States