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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Shirley Ryan AbilityLab
Study ID
NCT05424172
Status
Recruiting
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Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Stage-I, Group 1: Self monitoring using Non-interactive App — BEHAVIORAL
    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.
  • Stage-I, Group 2: Self monitoring using Interactive App — BEHAVIORAL
    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.
  • Stage-II, Groups 1a/2a: E-Coaching 1x per month — BEHAVIORAL
    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).
  • Stage-II, Groups 1b/2b: E-Coaching 2x per month — BEHAVIORAL
    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).

Study Details

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.

Key Dates

Start date
Nov 2, 2022
Status verified
May 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Stage-I: Self Monitoring Exercise Using a Health App
    Participants will be randomized into one of two groups: Group 1 (self monitoring using a non-interactive app), and Group 2 (self monitoring using an interactive app). Participants in both groups will be provided a customized exercise program to complete over the duration of the study. Within either app, participants will be able to view assigned exercises, log additional exercises completed, complete questionnaires as needed, and access additional resources. Participants will use their own smartphone to receive the health app. Participants will continue using their Stage-I app intervention for the entire duration of the study (weeks 1-24).
  • Experimental: Stage-II: Strategy to Address Non-Adherence
    After 12 weeks, the participants will be categorized as adherents or non-adherents based on their rates of adhering to the SCI exercise guidelines during Stage-I. Non-adherents (those who met the exercise guidelines \<50% of the weeks) will be randomized to receive an augmented intervention of motivational interviewing-based e-coaching (2x per month or 4x per month) in addition to their Stage-I assigned app for 12 weeks (weeks 13-24) to further increase rates of exercise. All non-adherents who will be assigned to the e-coaching interventions will be asked to complete at least daily EMA surveys. A coach who is trained in motivational interviewing will review the EMA data and work collaboratively with participants to identify barriers and facilitators and develop individualized strategies to improve exercise adherence. Adherents (those who met the exercise guidelines \>50% of the weeks) will continue with only their Stage-I assigned app intervention throughout Stage-II.

Primary Outcome Measure

Rate of Adherence to SCI exercise guidelines [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Shirley Ryan AbilityLabChicagoIllinois60611
Sara Nataletti, PhD
[email protected]
312-238-7113

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