SCI Step Together: Improving Physical Activity Participation Among Individuals With SCI Who Ambulate

NCT05063617 | Completed

• 2 other identifiers: SCIStepTogetherH21-01279
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

exercise; health promotion; smartphone; telemedicine; recreation

Outcome Measures

Primary Outcomes (16)

• Recruitment rate

  Divide the total number of participants enrolled by the number of participants contacted

  8 weeks

• Eligibility rate

  Number of potential participants excluded from the total number of interested participants

  8 weeks

• Retention rate

  Number of participants who completed at least some part of the intervention from those who were randomized

  8 weeks

• Adherence rate

  Number of participants who completed testing and follow-up measures

  8 weeks

• Costs

  Cost of producing software and app, participant remuneration, and cost of health behaviour coach

  8 weeks

• Staff preparation time

  The number of hours it requires staff to recruit partners and participants, liaise participants, and enter participant data

  Feasibility metrics will be recorded throughout the study. Feasibility will be assessed at the end of the 8-weeks.

• Number of adverse events

  Number of health problems reported over the course of the intervention

  8 weeks

• Compliance

  The number of modules completed by each intervention participant in the app

  8 weeks

• Number of log ins

  The number of times each intervention group participant logs into the app on a weekly basis

  8 weeks

• Duration of log ins

  The duration of each log in for each intervention group participant on a weekly basis

  8 weeks

• Qualitative interview

  A semi-structured interview with intervention group participants to explore the experiences with the app

  8 weeks

• Basic Psychological Needs - The Psychological Need Satisfaction in Exercise Scale.

  Basic Psychological Needs will be assessed using the The Psychological Need Satisfaction in Exercise Scale (Wilson et al., 2006). This 18-item scale assesses the satisfaction of the psychological needs for exercise using a 6-point Likert scale ranging from 1 (false) to 6 (true) (Wilson et al., 2006). A mean can be calculated for each psychological need (6-items each for autonomy, competence, and relatedness) with a higher score representing greater satisfaction of that need.

  Change in Basic Psychological Needs will be assessed at three time points: Baseline, Week 4, and Week 8

• Social Support - Sallis' social support questionnaire

  Social support will be measured using a modified version of Sallis' social support questionnaire (Sallis et al., 1987). The 7-item survey uses a 6-point Likert-type scale and assesses emotional support (3 items) and practical support (4 items). A higher score means individuals feel a greater sense of social support.

  Change in Social Support will be assessed at three time points: Baseline, Week 4, and Week 8

• Autonomous and Controlled Motivation - The Treatment Self-Regulation for Exercise Scale

  Motivation will be assessed by the The Treatment Self-Regulation for Exercise Scale. The 15-item scale uses a 7-point Likert scale ranging from 1 (not at all true) to 7 (very true) to assess why one would engage in exercise activities (Levesque et al., 2007). A higher score is more autonomous motivation.

  Change in Motivation will be assessed at three time points: Baseline, Week 4, and Week 8

• Behaviour Change Factors - The Determinants of Physical Activity Questionnaire

  Behaviour change factors will be assessed using the The Determinants of Physical Activity Questionnaire. A modified version will be used to assess the following domains targeted in the intervention: Knowledge, Beliefs about Capabilities, Skills, Social Influences, Beliefs about Consequences, Action Planning, Coping Planning, and Goal Conflict (24-items). The questionnaire uses a scale from 1 to 7 with 1 being strongly disagree, and 7 being strongly agree.

  Change in Behaviour Change Factors will be assessed at three time points: Baseline, Week 4, and Week 8

• Action Control - The Action Control Scale (Sniehotta et al., 2005).

  Action control will be assessed with 6 items that ask participants to indicate the extent to which they self-monitor their physical activity (1 = definitely false; 7 = definitely true). (Sniehotta et al., 2005).

  Change in Action Control will be assessed at three time points: Baseline, Week 4, and Week 8

Secondary Outcomes (3)

• Leisure-Time Physical Activity - The Leisure-Time Physical Activity Questionnaire

  Change in Leisure-Time Physical Activity will be assessed at three time points: Baseline, Week 4, and Week 8

• Quality of Physical Activity Participation - Measure of Experiential Aspects of Participation

  Change in Quality of Physical Activity Participation will be assessed at three time points: Baseline, Week 4, and Week 8

• Employment - The Short Form Craig Handicap Assessment and Reporting

  Change in Employment will be assessed at three time points: Baseline, Week 4, and Week 8

Study Arms (2)

Wait-List Control

NO INTERVENTION

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.

mHealth Intervention

EXPERIMENTAL

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 (this will be the program lead, SL). 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.

Device: SCI Step Together

Interventions

SCI Step Together DEVICE

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 to apply the strategies in their own goals for that week along with embedded questions to discuss with their community coach 3) behavioural support from the community coach and 4) peer support from the discussion group.

mHealth Intervention

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead
• Curatio Networks Inc.: collaborator

Study Sites (1)

University of British Columbia Okanagan

Kelowna, British Columbia, V1V 1V7, Canada

Location

Related Publications (1)

• 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.

  PMID: 35984695 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Study Officials

• Kathleen A Martin Ginis, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: October 1, 2021
• Study Start: July 29, 2021
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)