Health Technology to Improve Exercise in axSpA

Study Overview
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Brief Summary
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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.

Official Title
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Physical Activity in Axial Spondyloarthritis: Development and Implementation of an Evidence-Based Health Technology Approach to Improve Adherence to Recommended Guidelines

Conditions
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Axial Spondyloarthritis

Intervention / Treatment
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* Other: Health technology-based intervention strategy


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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. | Other: Health technology-based intervention strategy<br>* Patient-centered, technology-based intervention strategy aimed at increasing physical activity in patients with axSpA<br>|
| No Intervention: Control Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Assessed electronically by an e-survey platform at baseline, 3, 6, 9 and 12 weeks in the intervention and control groups. | 
| 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. | Assessed electronically by an e-survey platform at baseline, 3, 6, 9 and 12 weeks in the intervention and control groups. | 
| 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. | Assessed at baseline and at 12 weeks. | 
| 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. | Assessed at baseline and at 12 weeks. | 
| 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' | Assessed at baseline and at 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From baseline, assessed up to 12 weeks. | 
| 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. | From baseline, assessed up to 12 weeks. | 
| Number of accepted invites over the course of 12 weeks | Acceptance of planned exercise, as measured by uptake of health technology-based intervention strategy | From baseline, assessed up to 12 weeks. | 
| 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 | From baseline, assessed up to 12 weeks. | 
| 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 | From baseline, assessed up to 12 weeks. | 
| 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. | Assessed at 12 weeks. | 
| Number of enrolled participants who complete the study | Adherence, as measured by the rate of study completion. | Assessed at 12 weeks. |