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

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
SCI Step Together
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injuries focused on measuring exercise, health promotion, smartphone, telemedicine, recreation

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of British Columbia Okanagan

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Wait-List Control

mHealth Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Recruitment rate
Divide the total number of participants enrolled by the number of participants contacted
Eligibility rate
Number of potential participants excluded from the total number of interested participants
Retention rate
Number of participants who completed at least some part of the intervention from those who were randomized
Adherence rate
Number of participants who completed testing and follow-up measures
Costs
Cost of producing software and app, participant remuneration, and cost of health behaviour coach
Staff preparation time
The number of hours it requires staff to recruit partners and participants, liaise participants, and enter participant data
Number of adverse events
Number of health problems reported over the course of the intervention
Compliance
The number of modules completed by each intervention participant in the app
Number of log ins
The number of times each intervention group participant logs into the app on a weekly basis
Duration of log ins
The duration of each log in for each intervention group participant on a weekly basis
Qualitative interview
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.
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
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
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
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).
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).

Secondary Outcome Measures

Leisure-Time Physical Activity - The Leisure-Time Physical Activity Questionnaire
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
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
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.

Full Information

First Posted
August 10, 2021
Last Updated
May 17, 2022
Sponsor
University of British Columbia
Collaborators
Curatio Networks Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05063617
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 29, 2021 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Curatio Networks Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
exercise, health promotion, smartphone, telemedicine, recreation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wait-List Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
mHealth Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SCI Step Together
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
Divide the total number of participants enrolled by the number of participants contacted
Time Frame
8 weeks
Title
Eligibility rate
Description
Number of potential participants excluded from the total number of interested participants
Time Frame
8 weeks
Title
Retention rate
Description
Number of participants who completed at least some part of the intervention from those who were randomized
Time Frame
8 weeks
Title
Adherence rate
Description
Number of participants who completed testing and follow-up measures
Time Frame
8 weeks
Title
Costs
Description
Cost of producing software and app, participant remuneration, and cost of health behaviour coach
Time Frame
8 weeks
Title
Staff preparation time
Description
The number of hours it requires staff to recruit partners and participants, liaise participants, and enter participant data
Time Frame
Feasibility metrics will be recorded throughout the study. Feasibility will be assessed at the end of the 8-weeks.
Title
Number of adverse events
Description
Number of health problems reported over the course of the intervention
Time Frame
8 weeks
Title
Compliance
Description
The number of modules completed by each intervention participant in the app
Time Frame
8 weeks
Title
Number of log ins
Description
The number of times each intervention group participant logs into the app on a weekly basis
Time Frame
8 weeks
Title
Duration of log ins
Description
The duration of each log in for each intervention group participant on a weekly basis
Time Frame
8 weeks
Title
Qualitative interview
Description
A semi-structured interview with intervention group participants to explore the experiences with the app
Time Frame
8 weeks
Title
Basic Psychological Needs - The Psychological Need Satisfaction in Exercise Scale.
Description
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.
Time Frame
Change in Basic Psychological Needs will be assessed at three time points: Baseline, Week 4, and Week 8
Title
Social Support - Sallis' social support questionnaire
Description
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.
Time Frame
Change in Social Support will be assessed at three time points: Baseline, Week 4, and Week 8
Title
Autonomous and Controlled Motivation - The Treatment Self-Regulation for Exercise Scale
Description
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.
Time Frame
Change in Motivation will be assessed at three time points: Baseline, Week 4, and Week 8
Title
Behaviour Change Factors - The Determinants of Physical Activity Questionnaire
Description
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.
Time Frame
Change in Behaviour Change Factors will be assessed at three time points: Baseline, Week 4, and Week 8
Title
Action Control - The Action Control Scale (Sniehotta et al., 2005).
Description
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).
Time Frame
Change in Action Control will be assessed at three time points: Baseline, Week 4, and Week 8
Secondary Outcome Measure Information:
Title
Leisure-Time Physical Activity - The Leisure-Time Physical Activity Questionnaire
Description
Physical activity will be measured using the The Leisure-Time Physical Activity Questionnaire-SCI (LTPAQ-SCI).
Time Frame
Change in Leisure-Time Physical Activity will be assessed at three time points: Baseline, Week 4, and Week 8
Title
Quality of Physical Activity Participation - Measure of Experiential Aspects of Participation
Description
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).
Time Frame
Change in Quality of Physical Activity Participation will be assessed at three time points: Baseline, Week 4, and Week 8
Title
Employment - The Short Form Craig Handicap Assessment and Reporting
Description
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.
Time Frame
Change in Employment will be assessed at three time points: Baseline, Week 4, and Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen A Martin Ginis, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia Okanagan
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1V 1V7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Sharing individual participant data is not part of our ethical approval.
Citations:
PubMed Identifier
35984695
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.
Results Reference
derived

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

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