- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04249817
Keeping Stable Inflammatory Arthritis Patients in Their Communities With the Advanced Clinician Practitioner in Arthritis Care (ACPAC)
Keeping Stable Inflammatory Arthritis Patients in Their Communities With the Advanced Clinician Practitioner in Arthritis Care (ACPAC)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rationale: To determine, using a mixed-methods design, the impact of a rheumatology appointment via video conferencing combined with on-site pre-assessment by an Advance Clinician Practioner in Arthritis Care (ACPAC)-trained ERP compared to usual in-clinic care during a one-year period of follow-up for a cohort of persons with stable, well-controlled inflammatory arthritis residing in areas of low rheumatology supply.
Research Questions: For people with stable IA residing in areas of low rheumatology supply, is it feasible to provide follow-up to people with stable, well-controlled IA using videoconferencing and an assessment by an extended role practitioner? Does VC with ERP pre-assessment change quality of life and barriers to care perceived by people with stable, well-controlled IA?
Methods: Mixed-methods design. Randomized controlled trial with 2 groups: VC with ERP (VC-ERP) and usual care (UC). Pre- and Post-trial Interviews. Study procedures will be as follows:
- Pre-trial Interview - 15 minute telephone interview that will be audio taped. Will take place no more than one month before baseline study visit. Participant will be asked about experience traveling to rheumatologist and barriers to receiving care closer to home.
- Baseline visit - This visit will be a regularly scheduled appointment with the participant's rheumatologist. The participant will complete a package of four questionnaires and the rheumatologist will assess disease activity.
- Randomization - after completion of the baseline visit, participants will be randomized either to VC-ERP or UC.
- Follow-up Visits - There will be three follow-up visits 6, 12, and 13 months after the baseline study visit. Participants assigned to UC will be seen by their rheumatologist at the clinic as usual for all visits. At each visit, the participant wil complete a package of four questionnaires and the rheumatologist will assess disease activity. Participants assigned to VC-ERP will have their first two follow-up visits at an OTN site. There they will complete a package of four questionnaires, meet with the ERP for an assessment of disease activity, then connect with their rheumatologist by video conference. The final visit will take place in the rheumatologist's office, where the patient will complete a package of four questionnaires and the rheumatologist will assess disease activity.
- Post-trial interview - 15 minute telephone interview that will be audio taped. Will take place no more than one month after final follow-up visit. Participants assigned to UC, will be asked the same questions as first interview. Participants assigned to VC-ERP, will be asked questions about their experience with the therapist and OTN during the study period
Significance: From perspective of people with stable, well-controlled IA, we will understand the barriers they perceive when travelling for rheumatology care far from their communities and whether this new model of care might help to mitigate some of that burden. This model already exists in Ontario and it's important to understand its value to people with stable IA and determine whether it is good use of an extended role practitioner's time.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Kingston, Ontario, Canada, K7L 3E4
- Dr. Henry Averns
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Ottawa, Ontario, Canada, K2A 3Z3
- Dr. Ashley Sterrett
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- adults ≥18 years
- clinical diagnosis of inflammatory arthritis (i.e. rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis)
- inflammatory arthritis that is in remission or a low disease state as determined using a valid measure prior to study start
- travel to clinic ≥100 km round-trip
- able to read and write English
- willing/able to provide informed consent
- OHIP coverage.
Exclusion Criteria:
- Inflammatory arthritis that is neither in remission or in a low disease state as determined using a valid measure prior to study start
- complex rheumatic disease (i.e. lupus, vasculitis)
- travel to clinic <100 km round-trip
- children/youth < 18 years
- unable to read and write English
- unwilling/unable to provide informed consent
- no OHIP coverage.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Video conferencing with extended role practitioner
Participant goes to Ontario Telemedicine site for follow-up.
At site, participant will get a physical assessment by an extended role practitioner and then will connect to their rheumatologist by videoconferencing for completion of follow-up.
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Participant goes to Ontario Telemedicine site for follow-up.
At site, participant will get a physical assessment by an extended role practitioner and then will connect to their rheumatologist by videoconferencing for completion of follow-up.
|
No Intervention: Usual care
Participant goes to their rheumatologist's clinic for follow-up, including physical assessment by their rheumatologist, as they would normally.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
European Quality of Life Questionnaire with 5 Dimensions and 5 Levels (EQ5D-5L)
Time Frame: 13 months
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Overall health:
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13 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
9-item Visit Satisfaction Questionnaire (VSQ9)
Time Frame: 13 months
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9 items on satisfaction with visit rated on a scale of 1 (poor) to 5 (excellent).
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13 months
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5-item Compliance Questionnaire Rheumatology
Time Frame: 13 months
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5 items on medication adherence rated on a scale of 1(strongly disagree) to 4 (strongly agree).
Higher ratings indicate better adherence.
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13 months
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Health Assessment Questionnaire Disability Index (HAQ-DI)
Time Frame: 13 months
|
Disability is evaluated by:
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13 months
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28-joint Disease Activity Score (DAS28- for rheumatoid arthritis)
Time Frame: 13 months
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Disease activity measure for IA patients with Rheumatoid Arthritis. Calculated with an algorithm using the following four items:
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13 months
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Disease Activity for Psoriatic Arthritis (DAPSA)
Time Frame: 13 months
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Disease Activity measure for IA patients with Psoriatic Arthritis Calculated as the sum of the following five items:
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13 months
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Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time Frame: 13 months
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Disease activity measure for IA patients with Ankylosing Spondylitis. Calculated with an algorithm using the following five items:
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13 months
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 238-2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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