Keeping Stable Inflammatory Arthritis Patients in Their Communities With the Advanced Clinician Practitioner in Arthritis Care

NCT04249817 | Terminated

• 1 other identifier: 238-2019
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief Summary

In Ontario, rheumatology services are in short supply. Many people with inflammatory arthritis (IA) are traveling long distances for care and face geographical/ financial challenges in so doing. Travel burden may be decreased and satisfaction with care improved by integrating existing health care resources. A few rheumatologists in Ontario have adopted a video conferencing (VC) model for follow-up of stable IA patients using the Ontario Telemedicine Network (OTN) with Extended Role Practitioners (ERPs) doing on-site assessments. Anecdotal evidence suggests this model benefits both patient and rheumatologist. We will determine how people with stable well-controlled IA, living more than 100 km round-trip from the rheumatology clinic, perceive quality of life before, during and after VC with ERP follow-up visits compared to usual care. Disease activity, functional status, medication adherence, patient satisfaction, and barriers to care will also be measured.

Conditions

Inflammatory Arthritis

Outcome Measures

Primary Outcomes (1)

• European Quality of Life Questionnaire with 5 Dimensions and 5 Levels (EQ5D-5L)

  Overall health: 1. Rated in five dimensions as follows: Mobility from 1 (no problems) to 5 (unable to); Self-care from 1 (no problems) to 5 (unable to); Usual Activities from 1 (no problems) to 5 unable to); Pain/Discomfort from 1 (no pain) to 5 (extreme pain); Anxiety/Depression from 1 (not anxious/depressed) to 5 (extremely anxious/depressed) 2. Rated on a visual analog scale from 0 (worst health you can imagine) to 100 (best health you can imagine).

  13 months

Secondary Outcomes (6)

• 9-item Visit Satisfaction Questionnaire (VSQ9)

  13 months

• 5-item Compliance Questionnaire Rheumatology

  13 months

• Health Assessment Questionnaire Disability Index (HAQ-DI)

  13 months

• 28-joint Disease Activity Score (DAS28- for rheumatoid arthritis)

  13 months

• Disease Activity for Psoriatic Arthritis (DAPSA)

  13 months

Study Arms (2)

Video conferencing with extended role practitioner

EXPERIMENTAL

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.

Other: Video Conferencing with Exteneded Role Practitioner (VC-ERP)

Usual care

NO INTERVENTION

Participant goes to their rheumatologist's clinic for follow-up, including physical assessment by their rheumatologist, as they would normally.

Interventions

Video Conferencing with Exteneded Role Practitioner (VC-ERP) OTHER

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.

Video conferencing with extended role practitioner

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Canadian Initiative for Outcomes in Rheumatology Care: collaborator

Study Sites (3)

Dr. Henry Averns

Kingston, Ontario, K7L 3E4, Canada

Location

Dr. Ashley Sterrett

Ottawa, Ontario, K2A 3Z3, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: January 31, 2020
• Study Start: September 5, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: July 14, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)