SCI Step Together: Improving Physical Activity Participation Among Individuals With SCI Who Ambulate
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|ClinicalTrials.gov Identifier: NCT05063617|
Recruitment Status : Completed
First Posted : October 1, 2021
Last Update Posted : May 18, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Device: SCI Step Together||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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|
|Actual Study Start Date :||July 29, 2021|
|Actual Primary Completion Date :||October 1, 2021|
|Actual Study Completion Date :||December 1, 2021|
No Intervention: Wait-List Control
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.
Experimental: mHealth Intervention
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
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.
- Recruitment rate [ Time Frame: 8 weeks ]Divide the total number of participants enrolled by the number of participants contacted
- Eligibility rate [ Time Frame: 8 weeks ]Number of potential participants excluded from the total number of interested participants
- Retention rate [ Time Frame: 8 weeks ]Number of participants who completed at least some part of the intervention from those who were randomized
- Adherence rate [ Time Frame: 8 weeks ]Number of participants who completed testing and follow-up measures
- Costs [ Time Frame: 8 weeks ]Cost of producing software and app, participant remuneration, and cost of health behaviour coach
- Staff preparation time [ Time Frame: Feasibility metrics will be recorded throughout the study. Feasibility will be assessed at the end of the 8-weeks. ]The number of hours it requires staff to recruit partners and participants, liaise participants, and enter participant data
- Number of adverse events [ Time Frame: 8 weeks ]Number of health problems reported over the course of the intervention
- Compliance [ Time Frame: 8 weeks ]The number of modules completed by each intervention participant in the app
- Number of log ins [ Time Frame: 8 weeks ]The number of times each intervention group participant logs into the app on a weekly basis
- Duration of log ins [ Time Frame: 8 weeks ]The duration of each log in for each intervention group participant on a weekly basis
- Qualitative interview [ Time Frame: 8 weeks ]A semi-structured interview with intervention group participants to explore the experiences with the app
- Basic Psychological Needs - The Psychological Need Satisfaction in Exercise Scale. [ Time Frame: Change in Basic Psychological Needs will be assessed at three time points: Baseline, Week 4, and Week 8 ]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.
- Social Support - Sallis' social support questionnaire [ Time Frame: Change in Social Support will be assessed at three time points: Baseline, Week 4, and Week 8 ]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.
- Autonomous and Controlled Motivation - The Treatment Self-Regulation for Exercise Scale [ Time Frame: Change in Motivation will be assessed at three time points: Baseline, Week 4, and Week 8 ]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.
- Behaviour Change Factors - The Determinants of Physical Activity Questionnaire [ Time Frame: Change in Behaviour Change Factors will be assessed at three time points: Baseline, Week 4, and Week 8 ]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.
- Action Control - The Action Control Scale (Sniehotta et al., 2005). [ Time Frame: Change in Action Control will be assessed at three time points: Baseline, Week 4, and Week 8 ]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).
- Leisure-Time Physical Activity - The Leisure-Time Physical Activity Questionnaire [ Time Frame: Change in Leisure-Time Physical Activity will be assessed at three time points: Baseline, Week 4, and Week 8 ]Physical activity will be measured using the The Leisure-Time Physical Activity Questionnaire-SCI (LTPAQ-SCI).
- Quality of Physical Activity Participation - Measure of Experiential Aspects of Participation [ Time Frame: Change in Quality of Physical Activity Participation will be assessed at three time points: Baseline, Week 4, and Week 8 ]Quality of physical activity participation will be assessed using The Measure of Experiential Aspects of Participation (MeEAP).The scale is a questionnaire to assess the six experiential aspects of participation (i.e., belongingness, meaning, mastery, engagement, challenge, and autonomy) across life domains (Caron et al., 2019). The scale is completed separately for each life domain with 12-items. Participants will be asked to complete the scale for the exercise and sport domains only, for a total 24 items. Participants respond using a 7-point Likert type scale ranging from 1 (strongly disagree) and 7 (strongly agree).
- Employment - The Short Form Craig Handicap Assessment and Reporting [ Time Frame: Change in Employment will be assessed at three time points: Baseline, Week 4, and Week 8 ]Employment will be assessed using the Craig Handicap Assessment and Reporting Technique - Short Form (CHART-SF).The CHART-SF will be modified to 2-items for the current study to only assess employment hours and financial earnings.
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|Ages Eligible for Study:||19 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- Have a spinal cord injury but use a wheelchair as primary mode of mobility
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05063617
|Canada, British Columbia|
|University of British Columbia Okanagan|
|Kelowna, British Columbia, Canada, V1V 1V7|
|Principal Investigator:||Kathleen A Martin Ginis, PhD||University of British Columbia|
Documents provided by Kathleen Martin Ginis, University of British Columbia:
|Responsible Party:||Kathleen Martin Ginis, Professor, University of British Columbia|
|Other Study ID Numbers:||
H21-01279 ( Other Identifier: UBC )
|First Posted:||October 1, 2021 Key Record Dates|
|Last Update Posted:||May 18, 2022|
|Last Verified:||May 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||Sharing individual participant data is not part of our ethical approval.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries