Recruiting

Health Technology

Sponsor:

University Health Network, Toronto

Code:

NCT05504616

Conditions

Axial Spondyloarthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Health technology-based intervention strategy

Study Details

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.

Conditions

Axial Spondyloarthritis

Study ID

NCT05504616

Start date

Jul 21, 2022

Status verified date

Nov, 2022

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.)

Study Design

Enrollment

106 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Group

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.

no intervention: Control Group

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.

Interventions

Health technology-based intervention strategy

Patient-centered, technology-based intervention strategy aimed at increasing physical activity in patients with axSpA

Primary outcome measure

  • Changes in levels of physical activity as measured by the International Physical Activity Questionnaire-Short Form questionnaire (IPAQ-SF) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Assessed at baseline and at 12 weeks. ]

Central Contacts and Locations

Central contacts

Jennifer Dutra

(416) 603-5800jennifer.dutra@uhnresearch.ca

Laura Passalent

(416) 603-5800laura.passalent@uhn.ca

Locations

University Health Network - Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Tina Ko

tina.ko@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Nov 3, 2022

Last verified

Nov, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2022-11-03.