Smartphone Technology and E-Coaching for Spinal Cord Injury

Overseen By Sara Nataletti, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Recent trauma, Pressure ulcer, Medically unstable, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

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. ^{1 3 5 8 9}

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Stage-II: Strategy to Address Non-Adherence Experimental Treatment 2 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 App Experimental Treatment 2 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).

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A mobile app designed for self-management after spinal cord injury was well-received by 20 inpatient participants, showing high usability scores (78.1/100 at discharge and 71.6/100 three months later).

Participants appreciated the app's accessibility, intuitive navigation, and flexibility, indicating it could be a valuable tool for helping newly injured patients manage their health and prevent secondary conditions after discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' Perspectives on the Usability of a Mobile App for Self-Management following Spinal Cord Injury. Singh, G., MacGillivray, M., Mills, P., et al.[2020]

A pilot study involving 20 participants with spinal cord injuries showed that a self-management mobile app was feasible to implement during inpatient rehabilitation, with high retention rates of 85% from admission to discharge.

Participants who used the app reported improved confidence in bowel self-management from admission to discharge, indicating potential benefits of the app in supporting self-management after spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a self-management mobile app for spinal cord injury during inpatient rehabilitation and following community discharge: A feasibility study. MacGillivray, MK., Sadeghi, M., Mills, PB., et al.[2021]

Individuals with spinal cord injury (SCI) experience low cardiovascular stress during physical therapy (PT) and occupational therapy (OT), with a median heart rate in the training zone not exceeding 5 minutes, indicating insufficient cardiovascular training benefits.

Despite self-reports of over 60 minutes of higher-intensity activity during therapy, actual heart rate measurements show a low correlation, suggesting that self-reported activity may not accurately reflect true physical exertion levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular Stress During Inpatient Spinal Cord Injury Rehabilitation. Zbogar, D., Eng, JJ., Noble, JW., et al.[2018]

Individuals with spinal cord injury (SCI) prefer passive sources like the Internet and DVDs for receiving physical activity information, highlighting the importance of accessible media.

Peers and health service providers are seen as the most trusted messengers for delivering physical activity messages, indicating a need for collaboration among healthcare professionals to tailor information for different stages of recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preferred methods and messengers for delivering physical activity information to people with spinal cord injury: a focus group study. Letts, L., Martin Ginis, KA., Faulkner, G., et al.[2022]

The Apple Watch Series 4 shows a significant improvement in measuring wheelchair pushes for users with spinal cord injury, with a mean absolute percent error (MAPE) of 9.20%, indicating it can effectively track physical activity in this population.

In comparison to the older Series 1, the Series 4 provides more accurate data, making it a promising tool for objectively measuring physical activity in wheelchair users, although it tends to overestimate the number of pushes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement Performance of Activity Measurements with Newer Generation of Apple Watch in Wheelchair Users with Spinal Cord Injury. Benning, NH., Knaup, P., Rupp, R.[2022]

Individuals with cervical spinal cord injury (cSCI) believe that wearable cameras can enhance the assessment of upper limb function by providing naturalistic data on hand use, potentially leading to improved rehabilitation therapies.

Participants expressed concerns about discomfort during long recordings and privacy issues, highlighting the need for miniaturized, user-friendly designs and features that allow users to control recordings to ensure their comfort and privacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives and recommendations of individuals with tetraplegia regarding wearable cameras for monitoring hand function at home: Insights from a community-based study. Bandini, A., Kalsi-Ryan, S., Craven, BC., et al.[2023]

References

1. China pubmed.ncbi.nlm.nih.gov

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]

2. United States pubmed.ncbi.nlm.nih.gov

Development of a Self-Management App for People with Spinal Cord Injury. [2020]

3. England pubmed.ncbi.nlm.nih.gov

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]

4. United States pubmed.ncbi.nlm.nih.gov

Patients' Perspectives on the Usability of a Mobile App for Self-Management following Spinal Cord Injury. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Implementing a self-management mobile app for spinal cord injury during inpatient rehabilitation and following community discharge: A feasibility study. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular Stress During Inpatient Spinal Cord Injury Rehabilitation. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Preferred methods and messengers for delivering physical activity information to people with spinal cord injury: a focus group study. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Measurement Performance of Activity Measurements with Newer Generation of Apple Watch in Wheelchair Users with Spinal Cord Injury. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Perspectives and recommendations of individuals with tetraplegia regarding wearable cameras for monitoring hand function at home: Insights from a community-based study. [2023]