50 Participants Needed

Smartphone Technology and E-Coaching for Spinal Cord Injury

AJ
SR
SN
Overseen BySara Nataletti, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Shirley Ryan AbilityLab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on exercise and app usage, so it's best to consult with the trial coordinators for specific guidance.

Is smartphone technology and e-coaching generally safe for humans?

The research articles provided do not contain specific safety data for smartphone technology and e-coaching interventions, so no relevant safety information is available from these sources.12345

How does the smartphone app treatment for spinal cord injury differ from other treatments?

This treatment is unique because it uses smartphone apps to help people with spinal cord injuries monitor their physical activity and manage their health independently. Unlike traditional methods that rely on interviews or self-reports, these apps provide real-time feedback and personalized coaching, making it easier for users to track their progress and stay motivated.24567

What data supports the effectiveness of the treatment Smartphone Technology and E-Coaching for Spinal Cord Injury?

Research shows that mobile apps can help people with spinal cord injuries manage their health by setting goals and tracking progress, which can improve self-management skills and confidence. Additionally, patients found these apps easy to use and helpful in preventing complications after discharge from rehabilitation.24789

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am someone with spinal cord injury, a caregiver, or a clinician for those with SCI.
Phase 2 and 3: Willing to download the study apps
I have a spinal cord injury at or below the C3-C4 level, which may be complete or incomplete.
See 7 more

Exclusion Criteria

I have not had surgery or experienced significant injury in the last 3 months.
I have a severe pressure ulcer that is either stage 3 or 4.
I do not have severe visual or cognitive issues affecting study participation.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Technology Development

Focus groups with participants, caregivers, and clinicians to customize smartphone-based apps for exercise adherence.

Not specified

Usability Testing

Conduct a usability study of custom apps to optimize their acceptability, appropriateness, and feasibility.

2 weeks

Stage-I SMART Trial

Participants use either a non-interactive or interactive app for exercise adherence, with regular updates for Group 2.

12 weeks

Stage-II SMART Trial

Non-adherent participants receive e-coaching to improve exercise adherence.

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • E-Coaching 2x per month
  • E-Coaching 4x per month
  • Self monitoring using Interactive App
  • Self monitoring using Non-interactive App
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Stage-II: Strategy to Address Non-AdherenceExperimental Treatment2 Interventions
Group II: Stage-I: Self Monitoring Exercise Using a Health AppExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials
212
Recruited
17,900+

Published Research Related to This Trial

The Accessercise smartphone app was developed to improve physical activity in individuals with spinal cord injuries (SCI) by targeting 13 specific behaviors, such as goal setting and increasing self-confidence, which are crucial for reducing sedentary lifestyles.
Using the Behaviour Change Wheel (BCW) framework, the study identified key mechanisms that could enhance the app's effectiveness, suggesting that it could serve as a model for future interventions aimed at improving health outcomes for people with SCI.
Applying the behaviour change wheel to assess the theoretical underpinning of a novel smartphone application to increase physical activity in adults with spinal cord injuries.Haley, JA., Rhind, DJA., Maidment, DW.[2023]
Stakeholder feedback from 75 participants, including individuals with spinal cord injuries and their caregivers, highlighted the importance of creating a user-friendly mobile app that promotes self-management skills to prevent secondary complications after discharge from rehabilitation.
The app's design focuses on individualization, goal-setting for self-management, and encouraging community participation, which are crucial for effective lifestyle changes and integration into the community post-injury.
Development of a Self-Management App for People with Spinal Cord Injury.Mortenson, WB., Singh, G., MacGillivray, M., et al.[2020]
A study involving 19 manual wheelchair users with chronic spinal cord injury found that accelerometers and self-reported assessments of physical activity showed low agreement, indicating that they measure different aspects of physical activity.
While accelerometers were effective in detecting brief or intermittent activities, the self-report measure was better for capturing activities like resistance training and wheeling on inclines, suggesting that using both methods together may provide a more comprehensive view of physical activity in this population.
Physical activity measurement in people with spinal cord injury: comparison of accelerometry and self-report (the Physical Activity Recall Assessment for People with Spinal Cord Injury).Ma, JK., McCracken, LA., Voss, C., et al.[2021]

Citations

Applying the behaviour change wheel to assess the theoretical underpinning of a novel smartphone application to increase physical activity in adults with spinal cord injuries. [2023]
Development of a Self-Management App for People with Spinal Cord Injury. [2020]
Physical activity measurement in people with spinal cord injury: comparison of accelerometry and self-report (the Physical Activity Recall Assessment for People with Spinal Cord Injury). [2021]
Patients' Perspectives on the Usability of a Mobile App for Self-Management following Spinal Cord Injury. [2020]
Implementing a self-management mobile app for spinal cord injury during inpatient rehabilitation and following community discharge: A feasibility study. [2021]
Cardiovascular Stress During Inpatient Spinal Cord Injury Rehabilitation. [2018]
Preferred methods and messengers for delivering physical activity information to people with spinal cord injury: a focus group study. [2022]
Measurement Performance of Activity Measurements with Newer Generation of Apple Watch in Wheelchair Users with Spinal Cord Injury. [2022]
Perspectives and recommendations of individuals with tetraplegia regarding wearable cameras for monitoring hand function at home: Insights from a community-based study. [2023]
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