NCT07525856

Acceptability of a Nurse-led Telehealth Remote Self-monitoring Model of Care in Patients With Rheumatoid Arthritis

Acceptability of a Nurse-led Telehealth Remote Self-monitoring Model of Care in Patients With Rheumatoid Arthritis, a Multicentre Randomized Pilot Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Canada urgently needs new ways to provide rheumatology care that improve treatment and make it easier for people to get high-quality care. E-health technology is a new and promising way to do this, but it hasn't been studied much yet in rheumatology. The investigators will test a new way to help people with rheumatoid arthritis at four clinics in Quebec. This study will check if the new approach is easy to use, fits well into the clinics' daily routine, and if both patients and healthcare workers find it helpful and acceptable. This new approach involves nurses helping patients check their own health from home using an online platform. 104 adults who have rheumatoid arthritis and who have had a flare-up or a change in their medication in the last three months, will participate. Some will start using the online self-monitoring tool right away for 16 months, while others will continue with their usual care for 8 months before trying the tool. During the time they use the tool, they will fill out monthly online questionnaires to check their health. A rheumatology nurse will review their answers, suggest any needed care, provide personalized health information, and be available to answer questions through messages. This new way of care, where nurses help patients monitor their rheumatoid arthritis from home, helps make better use of limited specialist time. It's more convenient for patients, especially those who live far away, and helps meet their needs between regular doctor visits while keeping the quality of care high.

Detailed description

Background: Limited access to rheumatologists in Canadian remote regions leads to delays in new-onset rheumatoid arthritis (RA) diagnosis and inadequate follow-up for disease flares or treatment adjustments. There is a critical need for innovative models of care addressing these unmet needs in resource-limited settings. E-health technologies offer a promising solution by bridging the gap between in-person rheumatology appointments. These tools can optimize the use of scarce specialist resources, enhance the continuity and quality of care, and provide greater convenience for patients-particularly in underserved or geographically isolated areas. By supporting timely interventions and patient-centered monitoring, e-health can play a vital role in improving outcomes and ensuring equitable access to care. Objectives: This study will evaluate the acceptability and feasibility of a nurse-led telehealth remote self-monitoring model of care for patients with RA. Primary Objective: Acceptability of a nurse-led telehealth remote self-monitoring program, defined as patient-reported perceptions of usefulness, ease of use, attitudes, and overall experience, and assessed with questionnaires and semi-structured interviews. Secondary Objectives: Feasibility using the RE-AIM implementation framework: * Reach: Proportion of eligible patients enrolled and comparison of participant versus non-participant characteristics. * Effectiveness: Frequency and relevance of nurse calls, healthcare utilization, health-related quality of life, disease activity, and medication adherence. * Adoption: Completion rate of remote monitoring questionnaires, study retention, and reasons for discontinuation. * Implementation: Fidelity to protocol, appropriateness of alerts, subsequent actions, and timeliness of in-person visits; identify barriers and facilitators. * Maintenance: Intention for continued use among healthcare providers and patients. Methods - The investigators will recruit 104 adults with RA who experienced a flare or required a DMARDs switch within the preceding three months, from 4 rheumatology practices (community and academic sites) providing care to \>15,000 RA patients. All participants will be randomized 1:1 to receive either immediate intervention (for 16 months) or delayed, i.e. usual care for 8 months (control period) followed by 8 months of intervention, consisting of remote self-monitoring using a web platform co-developed with patients, rheumatologists, and nurses. Rheumatology visits will be scheduled every 3-6 months, with additional visits as necessary. The intervention includes nurse-led remote self-monitoring of RA, with patients completing monthly self-assessments of disease activity (RADAI), symptoms and function (PROMIS-29). Rheumatology nurses will receive alerts if monitoring suggests moderate/high disease activity and will contact participants to determine care needed. Tailored information based on PROMIS-29 answers will be sent to facilitate self-management. Asynchronous messaging with rheumatology nurses and information on RA self-management will be available. Data will be collected using questionnaires and semi-structured interviews. Analysis will use quantitative (generalized linear mixed-effect models comparing within group changes \[8 months - baseline, both groups combined\] and between groups differences \[intervention versus control\] in continuous variables), and qualitative methods (thematic content analysis by two independent researchers). Impact and feasibility. A nurse-led remote self-monitoring of RA using a web-based platform codeveloped with patient input, has potential to enhance access to care and more efficiently use scarce rheumatology resources while providing high quality care.

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
OTHER	Nurse-led telehealth remote self-monitoring	Remote self-monitoring will use a web platform co-developed with patients, rheumatologists, and nurses. The intervention includes nurse-led remote self-monitoring of RA, with patients completing monthly self-assessments of disease activity (RADAI), symptoms and function (PROMIS-29). Rheumatology nurses will receive alerts if monitoring suggests moderate/high disease activity and will contact participants to determine care needed. Tailored information based on PROMIS-29 answers will be sent to facilitate self-management. Asynchronous messaging with rheumatology nurses and information on RA self-management will be available.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-09-01
• Completion: 2027-12-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

4 sites across 1 country: Canada