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Smartphone Technology and E-Coaching for Spinal Cord Injury

N/A

Recruiting

Research Sponsored by Shirley Ryan AbilityLab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Phase 1: Individual with diagnosis of SCI, formal or informal caregiver of an individual with an SCI, or clinician that regularly sees individuals with SCI

Phase 1: 18-80 years of age

Must not have

Phase 2 and 3: An active stage 3 or 4 pressure ulcer

Phase 2 and 3: Severe visual or cognitive problems that would affect the ability to complete the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from 12 weeks to 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trialwill improve physical activity in individuals with SCI through a customized health app & e-coaching, using a SMART trial to adapt dosage, timing & delivery.

Who is the study for?

This trial is for individuals aged 18-80 with a spinal cord injury (SCI), their caregivers, or clinicians who treat SCI patients. Participants must speak English and be willing to download and use study apps on their smartphones.

What is being tested?

The study tests how well a customized interactive smartphone app and e-coaching can help people with SCI stick to exercise guidelines. It starts by comparing two types of apps, then adds motivational e-coaching for those not meeting goals.

What are the potential side effects?

Since this trial involves the use of smartphone technology and coaching rather than medication, traditional side effects are not applicable. However, participants may experience frustration or lack of motivation if they do not see immediate improvements in adherence.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am someone with spinal cord injury, a caregiver, or a clinician for those with SCI.

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I am between 18 and 80 years old.

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I use a wheelchair or need help to walk.

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I am between 18 and 80 years old.

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I speak English.

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I own a smartphone with a data plan that can be used for the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe pressure ulcer that is either stage 3 or 4.

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I do not have severe visual or cognitive issues affecting study participation.

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I cannot use at least one arm or leg for exercise.

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I do not have severe visual or cognitive issues affecting study participation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from 12 weeks to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from 12 weeks to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from 12 weeks to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of Adherence to SCI exercise guidelines

Secondary study objectives

Change in Exercise Self-Efficacy from 12 to 24 weeks

Change in Exercise Self-Efficacy from Baseline to 12 weeks

Change in Exercise Self-Efficacy from Baseline to 24 weeks

+6 more

Other study objectives

Change in 10 Meter Walk or Wheelchair Propulsion Test from 12 to 24 Weeks

Change in 10 Meter Walk or Wheelchair Propulsion Test from Baseline to 12 Weeks

Change in 10 Meter Walk or Wheelchair Propulsion Test from Baseline to 24 Weeks

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Stage-II: Strategy to Address Non-AdherenceExperimental Treatment2 Interventions

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.

Group II: Stage-I: Self Monitoring Exercise Using a Health AppExperimental Treatment2 Interventions

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).

0 / 10Eligibility criteria met