Clinical trial NCT05063617: SCI Step Together: Improving Physical Activity Participation Among Individuals With SCI Who Ambulate
Official title: Assessing the Acceptability and Feasibility of an mHealth App to Increase the Quantity and Quality of Physical Activity Experiences Among Individuals With Spinal Cord Injury Who Ambulate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: exercise
health promotion
smartphone
telemedicine
recreation
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Curatio Networks Inc.
First posted: 2021-10-01
Enrollment: 21
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to either a wait-list control or intervention group. The wait-list control group will be instructed to maintain their current health habits and not to engage in any new physical activity or health programs for the next 8-weeks. The wait-list control group will be invited to access the intervention after 8-weeks.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The project aims to test the feasibility of a new digital (mHealth) physical activity support program, delivered through an innovative mHealth platform (Curatio) for individuals living with spinal cord injury (SCI) who walk. The rationale for this project is to understand whether a mHealth intervention for increasing the amount and quality of physical activity is feasible for individuals with SCI who walk. The plan is to assess engagement, acceptability and feasibility in addition to primary outcomes related to physical activity behaviour. The investigators hypothesize that the intervention will be feasible and acceptable to deliver to individuals with SCI who walk. The investigators also hypothesize that the intervention will be engaging but recommendations will be made by participants following the study. Finally, it is hypothesized that compared with individuals in the wait-list control group, individuals in the intervention group will experience the following improvements related to exercise after 8-weeks: fulfillment of basic psychological needs, greater autonomous motivation, have enhanced social support, better action control, improved facilitators for behaviour change, more leisure-time physical activity, better quality participation, and enhanced employment.

Detailed description: This randomized controlled trial will examine the feasibility and acceptability of a mobile health (mHealth) application called Stronger Together. Stronger Together is an app that hosts programs for individuals with chronic illnesses and disabilities. In this study, the investigators are developing and testing the Stronger Together program that aims to improve the quantity and quality of physical activity among ambulators with SCI. Furthermore, the study will also collect pilot data on the magnitude of the effects on physical activity participation (quality and quantity) and psychosocial influences on physical activity. Individuals living with SCI who walk and live in Canada or the United States will be recruited for this study and will be assigned to either a wait-list control or intervention group. The wait-list control group will be instructed to maintain current health habits and not to engage in any new physical activity or health programs for the next 8-weeks. The wait-list control group will be invited to access the intervention after 8-weeks.

Potential participants will be immediately directed to complete the consent forms/baseline measures in Qualtrics. Once consent and baseline measures are completed, participants will be randomized into either the wait-list control or intervention condition. The investigators will aim to recruit at least 8-10 participants with consent and baseline measures completed before randomization into conditions in order for there to be enough participants in the program at the same time for peer support. After the first 8-10 participants, individuals will be randomized immediately after baseline testing so that participants randomized to the intervention group can join others in the app right away. Randomization will be done by the investigators using a random numbers generator in blocks of 2 and 4 with even groups in each condition (i.e., n=10 per condition). Waitlist-control participants will be directed to continue normal daily activity. Intervention participants will be directed to the App store to download the Stronger Together app to proceed with app registration. Participants will then be connected with the community coach who is a 'real live person' who monitors in-app activity. Other in-app features include peer discussion groups, behavioural support, and educational modules to support strategies to increase the quantity and quality of physical activity.

The 8-week program features weekly blocks of content. Each week builds from the previous week and targets specific components related to the three basic psychological needs (autonomy, relatedness, competence). The overall cadence of each weekly block is maintained throughout. For example, each week contains: 1) education modules 2) a worksheet or guided practice 3) behavioural support from the community coach and 4) peer support from the discussion group. Participants in the intervention group will be encouraged to use the app as often as needed (but at least once per week) and actively participate in the programming. The community coach (SL) will prompt participants who have not engaged in the app in a week to remind participants to complete weekly modules. In-app data, including user metrics will be collected and analyzed for descriptive patterns and assess correlations with the outcome measures (e.g., is the amount of time spent in-app correlated with changes in behaviour).

Participants in both the intervention and control groups will be asked to participate in eight online questionnaires provided through the survey platform Qualtrics at three different time points (baseline/onboarding, 4- and 8-weeks of using the Stronger Together program). A link to these questionnaires which will be hosted on Qualtrics will be emailed to all participants.

After completing the final online survey (at 8-weeks), participants in the intervention group will be invited to participate in an interview to further explore their experiences and to increase understanding of factors that influence acceptability and satisfaction of the Stronger Together program. The interview will be structured whereby the participant will go through the application with the interviewer to discuss preferred components. This will provide a greater understanding of user engagement.

Additionally, feasibility metrics will be kept and recorded throughout the duration of the study.

Eligibility criteria: Inclusion Criteria:

* Can read and write in English
* Own a smartphone or tablet
* Are 19 years of age or older
* Are a Canadian or United States resident
* Have sustained a spinal cord injury
* Walk for their daily mode of mobility

Exclusion Criteria:

* Have a spinal cord injury but use a wheelchair as primary mode of mobility

Primary outcomes:
measure: Recruitment rate
timeFrame: 8 weeks
measure: Eligibility rate
timeFrame: 8 weeks
measure: Retention rate
timeFrame: 8 weeks
measure: Adherence rate
timeFrame: 8 weeks
measure: Costs
timeFrame: 8 weeks
measure: Staff preparation time
timeFrame: Feasibility metrics will be recorded throughout the study. Feasibility will be assessed at the end of the 8-weeks.
measure: Number of adverse events
timeFrame: 8 weeks
measure: Compliance
timeFrame: 8 weeks
measure: Number of log ins
timeFrame: 8 weeks
measure: Duration of log ins
timeFrame: 8 weeks
measure: Qualitative interview
timeFrame: 8 weeks
measure: Basic Psychological Needs - The Psychological Need Satisfaction in Exercise Scale.
timeFrame: Change in Basic Psychological Needs will be assessed at three time points: Baseline, Week 4, and Week 8
measure: Social Support - Sallis' social support questionnaire
timeFrame: Change in Social Support will be assessed at three time points: Baseline, Week 4, and Week 8
measure: Autonomous and Controlled Motivation - The Treatment Self-Regulation for Exercise Scale
timeFrame: Change in Motivation will be assessed at three time points: Baseline, Week 4, and Week 8
measure: Behaviour Change Factors - The Determinants of Physical Activity Questionnaire
timeFrame: Change in Behaviour Change Factors will be assessed at three time points: Baseline, Week 4, and Week 8
measure: Action Control - The Action Control Scale (Sniehotta et al., 2005).
timeFrame: Change in Action Control will be assessed at three time points: Baseline, Week 4, and Week 8
Secondary outcomes:
measure: Leisure-Time Physical Activity - The Leisure-Time Physical Activity Questionnaire
timeFrame: Change in Leisure-Time Physical Activity will be assessed at three time points: Baseline, Week 4, and Week 8
measure: Quality of Physical Activity Participation - Measure of Experiential Aspects of Participation
timeFrame: Change in Quality of Physical Activity Participation will be assessed at three time points: Baseline, Week 4, and Week 8
measure: Employment - The Short Form Craig Handicap Assessment and Reporting
timeFrame: Change in Employment will be assessed at three time points: Baseline, Week 4, and Week 8
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia Okanagan
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Kathleen A Martin Ginis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lawrason SVC, Brown-Ganzert L, Campeau L, MacInnes M, Wilkins CJ, Martin Ginis KA. mHealth Physical Activity Intervention for Individuals With Spinal Cord Injury: Planning and Development Processes. JMIR Form Res. 2022 Aug 19;6(8):e34303. doi: 10.2196/34303.