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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from 12 weeks to 24 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of Adherence to SCI exercise guidelines

Secondary outcome measures

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 outcome measures

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

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 / 6Eligibility criteria met

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Who is running the clinical trial?

Shirley Ryan AbilityLabLead Sponsor

194 Previous Clinical Trials

16,862 Total Patients Enrolled

Media Library

Self monitoring using Interactive App Clinical Trial Eligibility Overview. Trial Name: NCT05424172 — N/A

Spinal Cord Injury Research Study Groups: Stage-I: Self Monitoring Exercise Using a Health App, Stage-II: Strategy to Address Non-Adherence

Spinal Cord Injury Clinical Trial 2023: Self monitoring using Interactive App Highlights & Side Effects. Trial Name: NCT05424172 — N/A

Self monitoring using Interactive App 2023 Treatment Timeline for Medical Study. Trial Name: NCT05424172 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged twenty and over permitted to participate in this clinical experiment?

"To be eligible for this clinical trial, applicants must fall within the age range of 18 and 80. Separately, 134 trials are seeking participants younger than 18 years old while 718 studies recruit persons over 65."

Answered by AI

Who is qualified to join the research endeavor?

"In order to be accepted into this trial, those who apply must have sustained a spinal cord injury and their age should fall within the range of 18-80. The total number of participants that will be recruited is 50 individuals."

Answered by AI

Has this clinical trial opened enrollment yet?

"The clinical trial is actively recruiting participants, as indicated on the clinicaltrials.gov website. The initial posting of this medical study was registered on November 2nd 2022 and it has seen its latest edit take place on January 12th 2023."

Answered by AI

What is the targeted enrollment of this clinical trial?

"Affirmative. Records available on clinicaltrials.gov demonstrate that this trial, initially posted to the website on November 2nd 2022, is currently looking for applicants. A total of 50 participants must be enrolled across a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Arun Jayaraman, PT, PhD 2022. "Improving Adherence to Spinal Cord Injury Exercise Guidelines Using Smartphone Technology and E-coaching". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05424172.