Stage-II: Strategy to Address Non-Adherence for Spinal Cord Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Spinal Cord InjuryStage-I, Group 2: Self monitoring using Interactive App - Behavioral
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Spinal Cord Injury

Treatment Effectiveness

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: From 12 weeks to 24 weeks

24 weeks
Rate of Adherence to SCI exercise guidelines
Week 24
Change in 10 Meter Walk or Wheelchair Propulsion Test from 12 to 24 Weeks
Change in Barriers to Physical Activity Questionnaire for People with Mobility Impairments from 12 to 24 Weeks
Change in Exercise Self-Efficacy from 12 to 24 weeks
Change in Six-Minute Walk/Push Test from 12 to 24 weeks
Change in Spinal Cord Injury-Quality of Life Scales from 12 to 24 Weeks
Week 12
Change in 10 Meter Walk or Wheelchair Propulsion Test from Baseline to 12 Weeks
Change in Barriers to Physical Activity Questionnaire for People with Mobility Impairments from Baseline to 12 Weeks
Change in Exercise Self-Efficacy from Baseline to 12 weeks
Change in Six-Minute Walk/Push Test from Baseline to 12 weeks
Change in Spinal Cord Injury-Quality of Life Scales from Baseline to 12 Weeks
Week 24
Change in 10 Meter Walk or Wheelchair Propulsion Test from Baseline to 24 Weeks
Change in Barriers to Physical Activity Questionnaire for People with Mobility Impairments from Baseline to 24 Weeks
Change in Exercise Self-Efficacy from Baseline to 24 weeks
Change in Six-Minute Walk/Push Test from Baseline to 24 weeks
Change in Spinal Cord Injury-Quality of Life Scales from Baseline to 24 Weeks

Trial Safety

Trial Design

2 Treatment Groups

Stage-II: Strategy to Address Non-Adherence
1 of 2
Stage-I: Self Monitoring Exercise Using a Health App
1 of 2

Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: Stage-II: Strategy to Address Non-Adherence · No Placebo Group · N/A

Stage-II: Strategy to Address Non-AdherenceExperimental Group · 2 Interventions: Stage-II, Groups 1a/2a: E-Coaching 2x per month, Stage-II, Groups 1b/2b: E-Coaching 4x per month · Intervention Types: Behavioral, Behavioral
Stage-I: Self Monitoring Exercise Using a Health AppExperimental Group · 2 Interventions: Stage-I, Group 2: Self monitoring using Interactive App, Stage-I, Group 1: Self monitoring using Non-interactive App · Intervention Types: Behavioral, Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from 12 weeks to 24 weeks

Who is running the clinical trial?

Shirley Ryan AbilityLabLead Sponsor
173 Previous Clinical Trials
13,652 Total Patients Enrolled

Eligibility Criteria

Age 18 - 80 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a caregiver for an individual with an SCI.