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

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.

• Age category of eligible participants [Time frame: Until the end of recruiting period]
• Frequency of calls to nurses [Time frame: Up to the end of intervention at 16 months]
• Use of other health care services [Time frame: Every 3 months over 16 months]
• Health-related quality of life evaluated by the Patient-Reported Outcomes Measurement Information System-29 questionnaire [Time frame: Every 3 months over 16 months]
• Disease activity evaluated by the Clinical Disease Activity Index [Time frame: Every 3 to 6 months over 16 months]
• Proportion of medication adherence [Time frame: Every 3 months up to the end of intervention over 16 months]
• Completion rate of patient questionnaires for remote self-monitoring [Time frame: Every month during the intervention over 16 months]
• Proportion of participants still connecting to the web platform at study end [Time frame: At 16 months]
• Time spent on the web platform [Time frame: Up to the end of intervention at 16 months]
• Measuring the number of alerts per patient [Time frame: Up to the end of intervention at 16 months]
• Questionnaire for the evaluation of health professionals' acceptance of a new telemonitoring system [Time frame: At 16 months]
• Sex category of eligible patients [Time frame: Up to the end of recruiting period]