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
Shirley Ryan AbilityLab
50 participants
Nov 2, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria14
- Individual with diagnosis of SCI, formal or informal caregiver of an individual with an SCI, or clinician that regularly sees individuals with SCI
- -80 years of age
- English-speaking
- Willing to download the study apps
- Individual with diagnosis of SCI, complete (only paraplegia) or incomplete, cervical C3- C4 and below
- -80 years of age
- English-speaking
- Use a wheelchair as primary means of mobility or walk with or without assistive equipment
- At least 1-year post-SCI
- Not adhering to SCI-specific exercise guidelines as ascertained by self-report or during structured phone interview
- Interested in increasing exercise levels
- Ownership of a smartphone that can be used for the study and has a data plan
- Willing to successfully download and learn to use the study apps
- Able and willing to give written consent and comply with study procedures, including multiple in person follow-up visits
Exclusion Criteria9
- Severe visual or cognitive problems that would affect the ability to complete the study
- Does not own, or is unable to use a smartphone
- Trauma or surgery in the past three months
- An active stage 3 or 4 pressure ulcer
- Medically unstable to perform the home-based exercise as determined by Dr. Chen and his team, the evaluating physical therapist, or the participants' primary care physician.
- Unable to use at least one set of extremities to exercise
- Enrolled in a structured exercise program over the past three months
- Severe visual or cognitive problems that would affect the ability to complete the study
- Does not own, or is unable to use a smartphone
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Interventions
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.
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.
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).
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).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05424172