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RECRUITING
NCT05424172
NA

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

Sponsor: Shirley Ryan AbilityLab

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2022-11-02

Completion Date

2026-08-31

Last Updated

2025-04-20

Healthy Volunteers

No

Interventions

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).

Locations (1)

Shirley Ryan AbilityLab

Chicago, Illinois, United States