Back to resultsHealth Technology to Improve Exercise in axSpA
Primary Purpose
Axial Spondyloarthritis
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Health technology-based intervention strategy
Sponsored by
About this trial
This is an interventional treatment trial for Axial Spondyloarthritis
Eligibility Criteria
Inclusion Criteria:
- Adults (aged 18 and older) with a diagnosis of axSpA based on ASAS criteria
- Have access to email and a smart phone device (Android or iOS operating systems)
- Enrolled in the SPARCC Research Program
- Passes pre-participation health screen
Exclusion Criteria:
- Non-English speaking
- Not enrolled in the SPARCC Research Program
- Comorbidities or physical impairments that may preclude physical activity (e.g., symptomatic cardiovascular disease; wheelchair bound etc.)
Sites / Locations
- University Health Network - Toronto Western HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control Group
Arm Description
Participants randomized to the intervention group will receive an initial electronic communication (i.e. email) that includes: Link to physical activity education. This will be an educational module based on Phase 1 results and evidence-based literature regarding the benefits of physical activity in the general population and specific to axSpA. One week after receiving the physical activity educational module, participants will receive access to the ADAS application and an .ics file for each 3-week cycle of electronic calendar reminders to engage in physical activity.
Participants randomized to the control group will receive usual care, which includes standard rheumatology care and access to educational materials on the importance of exercise and physical activity available through the TWH Spondylitis Program and through the public domain. They will receive a link to the physical activity educational module at baseline. They also have access to the program physiotherapist for a single one-hour individualized exercise consultation as requested by either the patient or the treating rheumatologist.
Outcomes
Primary Outcome Measures
Changes in levels of physical activity as measured by the International Physical Activity Questionnaire-Short Form questionnaire (IPAQ-SF)
The IPAQ-SF is a self-report questionnaire designed to estimate total physical activity in MET-min/week by assessing the types of intensity of physical activity and sitting time that people do as part of their daily lives.
Changes in exercise behaviour as measured by an adapted Stanford Exercise Behaviours Questionnaire
2-item questionnaire measuring total time (minutes) spent on stretching and strengthening exercises each week.
Change in levels of physical activity as measured by Accelerometry
Participants wear an accelerometer for 7 consecutive days at baseline and again at 12 weeks. The participant will mail back the activity monitor using a pre-paid envelope following each seven-day period.
Change in perceived benefits and barriers to exercise as a result of the technology-based intervention strategy as measured by the Exercise Benefits/Barriers Scale (EBBS)
The EBBS measures perceptions regarding the benefits of, and barriers to, exercise.
Change in functioning and health as a result of the technology-based intervention strategy as measured by the ASAS Health Index
The self-report questionnaire measures functioning and health across 17 aspects of health and 9 environmental factors in patients with spondyloarthritis. The items measure the concept of 'functioning, disability and health'
Secondary Outcome Measures
Change in disease activity over the course of 12 weeks as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDI) questionnaire
Disease activity, including pain, fatigue and stiffness as measured by the BASDAI questionnaire (a 0 - 10 visual analog scale) weekly.
Change in function over the course of 12 weeks as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) questionnaire
Function as measured by the BASFI questionnaire (0 - 10 visual analog scale) weekly.
Number of accepted invites over the course of 12 weeks
Acceptance of planned exercise, as measured by uptake of health technology-based intervention strategy
Frequency of physical activity sessions as a result of the technology-based intervention strategy over the course of 12 weeks
Acceptance of planned exercise, as measured by uptake of health technology-based intervention strategy
Duration of physical activity sessions as a result of the technology-based intervention strategy over the course of 12 weeks
Acceptance of planned exercise, as measured by uptake of health technology-based intervention strategy
Acceptance of health technology-based intervention strategy, as measured by the Mobile Application Rating Scale
Acceptance of intervention, as measured by the Mobile Application Rating Scale. MARS is a 5-point scale from 1-inadequate or strongly disagree to 5-excellent or strongly agree that accesses app quality, app subjective quality, and perceived impact of the app on user's knowledge, intentions to change as well as the likelihood of actual change in the target health behaviour. Higher scores indicate greater quality and acceptance of the intervention.
Number of enrolled participants who complete the study
Adherence, as measured by the rate of study completion.
Full Information
NCT ID
NCT05504616
First Posted
July 29, 2022
Last Updated
November 2, 2022
Sponsor
University Health Network, Toronto
Collaborators
Canadian Initiative for Outcomes in Rheumatology Care
1. Study Identification
Unique Protocol Identification Number
NCT05504616
Brief Title
Health Technology to Improve Exercise in axSpA
Official Title
Physical Activity in Axial Spondyloarthritis: Development and Implementation of an Evidence-Based Health Technology Approach to Improve Adherence to Recommended Guidelines
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
Collaborators
Canadian Initiative for Outcomes in Rheumatology Care
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
Despite the known benefits of physical activity, the majority of Canadians fail to meet recommended guidelines. Patients with axial spondyloarthritis (axSpA) also fail to meet recommended guidelines. Exercise, a critical component of physical activity, is considered the cornerstone of axSpA management. Simple health technologies such as mobile phone messaging and email can be useful tools to increase engagement in regular physical activity among the general public and patients with chronic disease. As such, the aim of this research project is to develop and test a patient-centered strategy that provides education on the importance of physical activity and utilizes existing health technologies (such as smart phone applications) to encourage regular participation in physical activity. The results of this study are expected to demonstrate that patients with axSpA will increase their daily engagement in physical activity, and therefore improve symptoms, function and overall quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axial Spondyloarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Repeated measures randomized control pre-test/post-test design comparing an intervention group with a control group (usual care).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Participants randomized to the intervention group will receive an initial electronic communication (i.e. email) that includes:
Link to physical activity education. This will be an educational module based on Phase 1 results and evidence-based literature regarding the benefits of physical activity in the general population and specific to axSpA.
One week after receiving the physical activity educational module, participants will receive access to the ADAS application and an .ics file for each 3-week cycle of electronic calendar reminders to engage in physical activity.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants randomized to the control group will receive usual care, which includes standard rheumatology care and access to educational materials on the importance of exercise and physical activity available through the TWH Spondylitis Program and through the public domain. They will receive a link to the physical activity educational module at baseline. They also have access to the program physiotherapist for a single one-hour individualized exercise consultation as requested by either the patient or the treating rheumatologist.
Intervention Type
Other
Intervention Name(s)
Health technology-based intervention strategy
Intervention Description
Patient-centered, technology-based intervention strategy aimed at increasing physical activity in patients with axSpA
Primary Outcome Measure Information:
Title
Changes in levels of physical activity as measured by the International Physical Activity Questionnaire-Short Form questionnaire (IPAQ-SF)
Description
The IPAQ-SF is a self-report questionnaire designed to estimate total physical activity in MET-min/week by assessing the types of intensity of physical activity and sitting time that people do as part of their daily lives.
Time Frame
Assessed electronically by an e-survey platform at baseline, 3, 6, 9 and 12 weeks in the intervention and control groups.
Title
Changes in exercise behaviour as measured by an adapted Stanford Exercise Behaviours Questionnaire
Description
2-item questionnaire measuring total time (minutes) spent on stretching and strengthening exercises each week.
Time Frame
Assessed electronically by an e-survey platform at baseline, 3, 6, 9 and 12 weeks in the intervention and control groups.
Title
Change in levels of physical activity as measured by Accelerometry
Description
Participants wear an accelerometer for 7 consecutive days at baseline and again at 12 weeks. The participant will mail back the activity monitor using a pre-paid envelope following each seven-day period.
Time Frame
Assessed at baseline and at 12 weeks.
Title
Change in perceived benefits and barriers to exercise as a result of the technology-based intervention strategy as measured by the Exercise Benefits/Barriers Scale (EBBS)
Description
The EBBS measures perceptions regarding the benefits of, and barriers to, exercise.
Time Frame
Assessed at baseline and at 12 weeks.
Title
Change in functioning and health as a result of the technology-based intervention strategy as measured by the ASAS Health Index
Description
The self-report questionnaire measures functioning and health across 17 aspects of health and 9 environmental factors in patients with spondyloarthritis. The items measure the concept of 'functioning, disability and health'
Time Frame
Assessed at baseline and at 12 weeks.
Secondary Outcome Measure Information:
Title
Change in disease activity over the course of 12 weeks as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDI) questionnaire
Description
Disease activity, including pain, fatigue and stiffness as measured by the BASDAI questionnaire (a 0 - 10 visual analog scale) weekly.
Time Frame
From baseline, assessed up to 12 weeks.
Title
Change in function over the course of 12 weeks as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) questionnaire
Description
Function as measured by the BASFI questionnaire (0 - 10 visual analog scale) weekly.
Time Frame
From baseline, assessed up to 12 weeks.
Title
Number of accepted invites over the course of 12 weeks
Description
Acceptance of planned exercise, as measured by uptake of health technology-based intervention strategy
Time Frame
From baseline, assessed up to 12 weeks.
Title
Frequency of physical activity sessions as a result of the technology-based intervention strategy over the course of 12 weeks
Description
Acceptance of planned exercise, as measured by uptake of health technology-based intervention strategy
Time Frame
From baseline, assessed up to 12 weeks.
Title
Duration of physical activity sessions as a result of the technology-based intervention strategy over the course of 12 weeks
Description
Acceptance of planned exercise, as measured by uptake of health technology-based intervention strategy
Time Frame
From baseline, assessed up to 12 weeks.
Title
Acceptance of health technology-based intervention strategy, as measured by the Mobile Application Rating Scale
Description
Acceptance of intervention, as measured by the Mobile Application Rating Scale. MARS is a 5-point scale from 1-inadequate or strongly disagree to 5-excellent or strongly agree that accesses app quality, app subjective quality, and perceived impact of the app on user's knowledge, intentions to change as well as the likelihood of actual change in the target health behaviour. Higher scores indicate greater quality and acceptance of the intervention.
Time Frame
Assessed at 12 weeks.
Title
Number of enrolled participants who complete the study
Description
Adherence, as measured by the rate of study completion.
Time Frame
Assessed at 12 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults (aged 18 and older) with a diagnosis of axSpA based on ASAS criteria
Have access to email and a smart phone device (Android or iOS operating systems)
Enrolled in the SPARCC Research Program
Passes pre-participation health screen
Exclusion Criteria:
Non-English speaking
Not enrolled in the SPARCC Research Program
Comorbidities or physical impairments that may preclude physical activity (e.g., symptomatic cardiovascular disease; wheelchair bound etc.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Dutra
Phone
(416) 603-5800
Ext
5226
Email
jennifer.dutra@uhnresearch.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Passalent
Phone
(416) 603-5800
Ext
6149
Email
laura.passalent@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Passalent
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network - Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Ko
Email
tina.ko@uhn.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Health Technology to Improve Exercise in axSpA
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