Smartphone Technology and E-Coaching for Spinal Cord Injury
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Shirley Ryan AbilityLab
No Placebo Group
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.
Is using smartphone apps for self-monitoring a promising treatment for spinal cord injury?Yes, using smartphone apps for self-monitoring is promising for people with spinal cord injury. These apps can help track physical activity and health, improve self-management skills, and increase confidence in managing their condition. They offer a convenient way to stay active and monitor progress, which can lead to better health outcomes.35789
What safety data exists for smartphone and e-coaching treatments for spinal cord injury?The provided research does not directly address safety data for smartphone and e-coaching treatments for spinal cord injury. The studies focus on physical activity measurement, preferred methods for delivering physical activity information, theoretical underpinnings of smartphone applications, and measurement performance of activity trackers. None of these studies specifically evaluate the safety of the mentioned treatments.12389
What data supports the idea that Smartphone Technology and E-Coaching for Spinal Cord Injury is an effective treatment?The available research shows that smartphone apps for spinal cord injury (SCI) help people manage their health better after leaving the hospital. For example, a study found that a self-management app was easy to use and helped users set and track health goals, which improved their confidence in managing their condition. Another study showed that people using a mobile app felt more confident in managing their bowel health after their injury. These apps are designed to be user-friendly and support people in making lifestyle changes, which can help prevent further health issues. While the studies focus on the app's usability and potential benefits, more research is needed to confirm its effectiveness compared to other treatments.34569
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on exercise and app usage, so you may not need to change your medication routine.
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.
I am between 18 and 80 years old.
I use a wheelchair or need help to walk.
I am between 18 and 80 years old.
I speak English.
I own a smartphone with a data plan that can be used for the study.
Exclusion Criteria
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.
I cannot use at least one arm or leg for exercise.
I do not have severe visual or cognitive issues affecting study participation.
Participant Groups
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.
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).
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Shirley Ryan AbilityLabChicago, IL
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Who is running the clinical trial?
Shirley Ryan AbilityLabLead Sponsor
References
Preferred methods and messengers for delivering physical activity information to people with spinal cord injury: a focus group study. [2022]To explore the perceptions of people with spinal cord injury (SCI) regarding preferred messengers and methods for obtaining physical activity (PA) information.
Cardiovascular Stress During Inpatient Spinal Cord Injury Rehabilitation. [2018](1) To measure the amount of cardiovascular stress, self-reported physical activity, and accelerometry-measured physical activity by individuals with spinal cord injury (SCI) during physical therapy (PT) and occupational therapy (OT); and (2) to investigate the relations between these measures.
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]Purpose: To (1) evaluate the level of agreement between individually calibrated accelerometers and the self-reported Physical Activity Recall Assessment for People with Spinal Cord Injury when assessing moderate-vigorous physical activity; and (2) qualitatively examine the different components of physical activity each measure assesses.Materials/methods: Nineteen manual wheelchair users with chronic spinal cord injury (19.0 ± 12.9 years post injury, C5-L2 injury level) wore a wrist and spoke accelerometer for one week then returned to the lab and completed the Physical Activity Recall Assessment for People with Spinal Cord Injury for their last 3 days of accelerometer wear.Results: Bland-Altman plots revealed low levels of agreement between the two measures when measuring total (bias = -5.6 ± 70.41 min/d, 95% agreement limits = -143.6-132.4 min/d), wheeled (bias = -9.7 ± 30.2 min/d, 95% agreement limits = -69.0-49.5 min/d), and non-wheeled (bias =12.3 ± 53.8 min/d, 95% agreement limits = -93.1-117.6 min/d) moderate-vigorous physical activity. The accelerometer was beneficial for detecting intermittent or brief activities while the self-report measure was useful for measuring lifting activities (e.g., resistance training) and wheeling on inclined surfaces.Conclusion: Total and wheeled moderate-vigorous physical activity measured by an accelerometer and a self-report measure showed low agreement at the individual level. Additional research is needed to examine whether physical activity may be best measured using accelerometers and a self-report measure concurrently.Implications for RehabilitationAccurate physical activity measurement has important implications for understanding the relationship between physical activity and health outcomes.Many limitations exist to accurately measuring physical activity in people with spinal cord injury.The most commonly used measures of physical activity in spinal cord injury are accelerometers and the self-reported Physical Activity Recall Assessment for People with Spinal Cord Injury.Accelerometers and the Physical Activity Recall Assessment for People with Spinal Cord Injury show low levels of agreement, highlighting that there are differences in the specific physical activity patterns that each measure is able to capture.
Development of a Self-Management App for People with Spinal Cord Injury. [2020]With decreasing inpatient rehabilitation lengths of stay, there may be a greater risk of spinal cord injury (SCI) populations being discharged into the community without the self-management skills needed to prevent secondary complications. Recent advancements in mobile health has made mobile apps a feasible method of delivering population-based, self-management interventions to address SCI-specific secondary complications. The objective of this study is to describe stakeholder perspectives on the development of a functional mobile app to facilitate self-management skills needed to prevent secondary complications following recent SCI during inpatient rehabilitation. A user-centered design approach was used that involved an evolving mobile app and the collection of prospective qualitative data. Stakeholders from three groups were enrolled in the study: individuals admitted for rehabilitation following SCI (n = 20) and informal (n = 7) and formal (n = 48) caregivers. Iterative feedback was gathered from rehabilitation inpatients during ongoing interactions and via post-discharge exit questionnaires, from informal caregivers via one-on-one interviews, and from formal caregivers via series of focus groups at various phases throughout the design process. Three main themes emerged from the analysis: (1) being individualized and user friendly (i.e., developing an app that is simple and easy to use to facilitate universal uptake), (2) targeting goals to promote self-management (i.e., adopting self-management skills relative to personal goals and confidence), and (3) increasing participation and support-seeking to facilitate lifestyle change (i.e., encouraging leisure activities to facilitate community integration). Key stakeholder perspectives contributed to the development of a self-management mobile app that will be evaluated in future research.
Implementing a self-management mobile app for spinal cord injury during inpatient rehabilitation and following community discharge: A feasibility study. [2021]Objective: To determine the feasibility of implementing and evaluating a self-management mobile app for spinal cord injury (SCI) during inpatient rehabilitation and following community discharge. Design: Pilot feasibility study. Setting: Rehabilitation hospital and community. Participants: Inpatients from rehabilitation hospital following admission for their first SCI. Intervention: A mobile app was developed to facilitate self-management following SCI. The app consisted of 18 tools focusing on goal setting, tracking various health aspects, and identifying confidence regarding components of self-management. In-person training and follow-up sessions were conducted during inpatient rehabilitation and follow-up calls were provided after participants were discharged into the community. Main outcome measures: Participants completed outcome measures at baseline, community discharge, and 3-months post discharge. This study focused on feasibility indicators including recruitment, retention, respondent characteristics, adherence, and app usage. Additionally, participants' self-management confidence relating to SCI (e.g. medication, skin, bladder, pain) was evaluated over time. Results: Twenty participants (median age 39, IQR: 31 years, 85% male) enrolled in the study. Participants' Spinal Cord Injury Independence Measure (SCIM-III) median score was 23 and IQR was 33 (range: 7-84), which did not correlate with app usage. Retention from admission to discharge was 85% and 70% from discharge to 3-months post discharge. Individuals in the study who used the app entered data an average of 1.7x/day in rehabilitation (n = 17), and 0.5x/day in the community (n = 7). Participants' bowel self-management confidence improved between admission and discharge (P < 0.01). Conclusions: Feasibility indicators support a larger clinical trial during inpatient rehabilitation; however, there were challenges with retention and adherence following community discharge.
Patients' Perspectives on the Usability of a Mobile App for Self-Management following Spinal Cord Injury. [2020]With decreasing inpatient lengths of stay following spinal cord injury (SCI), newly injured patients may be discharged into the community without the self-management skills needed to prevent secondary conditions. A mobile app was developed to facilitate self-management skills following SCI in the inpatient rehabilitation and early community settings. The objective of this study was to explore patients' perspectives on the usability of this self-management app. A mixed-methods study design was implemented. The app was trialed at a local rehabilitation centre with 20 inpatient participants who experienced a SCI. They received mobile app training sessions throughout their inpatient rehabilitation. A thematic analysis was performed on qualitative data from post-discharge exit questionnaires and researchers' field notes. Quantitative data (in the form of participants' tool usage data and self-reported system usability scale scores) were collected at discharge and 3 months post-discharge. Three main themes emerged from the qualitative analysis: (1) being accessible to users (i.e., being easy to adopt and compatible with assistive technologies), (2) being intuitive to navigate (i.e., incorporating a simple app layout and a system of alert notifications), and (3) offering users flexibility (i.e., providing users with control over their data). The mobile app received above average mean system usability scale scores, both at discharge (78.1/100) and 3 months post-discharge (71.6/100). Given that participants found the app acceptable for use in inpatient rehabilitation and following discharge into the community, further testing is warranted to explore its efficacy in preventing secondary complications.
Perspectives and recommendations of individuals with tetraplegia regarding wearable cameras for monitoring hand function at home: Insights from a community-based study. [2023]Wearable cameras have great potential for producing novel outcome measures of upper limb (UL) function and guiding care in individuals with cervical spinal cord injury (cSCI) living in the community. However, little is known about the perspectives of individuals with cSCI on the potential adoption of this technology.
Measurement Performance of Activity Measurements with Newer Generation of Apple Watch in Wheelchair Users with Spinal Cord Injury. [2022]The level of physical activity (PA) of people with spinal cord injury (SCI) has an impact on long-term complications. Currently, PA is mostly assessed by interviews. Wearable activity trackers are promising tools to objectively measure PA under everyday conditions. The only off-the-shelf, wearable activity tracker with specific measures for wheelchair users is the Apple Watch.
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]People with spinal cord injuries (SCI) are physically inactive. Smartphone applications (or apps) may prove as one strategy to overcome this. This study examines the theoretical underpinning of a novel mHealth intervention that aims to improve physical activity in people with SCI, namely, the Accessercise smartphone app, using the behaviour change wheel (BCW).