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

NCT07525856 | Not Yet Recruiting

• 1 other identifier: 2026-8556
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Rheumatoid Arthritis (RA)

Keywords

Arthritis activity remote self-monitoring; Nurse-led telehealth intervention; Pilot randomised trial; Self-assessment of disease activity; RE-AIM implementation framework; Semi-structured interviews

Outcome Measures

Primary Outcomes (2)

• Acceptability of the intervention evaluated by a questionnaire

  The questionnaire of patients' perceived usefulness and ease of use of the remote self-monitoring web platform will be completed by participants at 16 months, rated using a 13-item questionnaire utilizing five-point Likert scales.

  At 16 months

• Acceptability of the intervention evaluated by a qualitative analysis

  Semi-structured interviews with patients and providers will be completed with a purposive sample of participants (diverse with respect to age, gender, ethnicity, education, disease type and duration, employment, urban/rural) at study end. Participants will meet in groups of 8-12 for 60-90 minutes; groups will continue until saturation of themes is obtained (estimated to be 2-3 groups). Topics will include perceived acceptability, convenience, satisfaction, beliefs, perceived usefulness and ease of use, how care received met patient needs, barriers and enablers to adopting this new model of care.

  At 16 months

Secondary Outcomes (15)

• Age category of eligible participants

  Until the end of recruiting period

• Frequency of calls to nurses

  Up to the end of intervention at 16 months

• Use of other health care services

  Every 3 months over 16 months

• Health-related quality of life evaluated by the Patient-Reported Outcomes Measurement Information System-29 questionnaire

  Every 3 months over 16 months

• Disease activity evaluated by the Clinical Disease Activity Index

  Every 3 to 6 months over 16 months

Study Arms (2)

Immediate intervention (for 16 months)

EXPERIMENTAL

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.

Other: Nurse-led telehealth remote self-monitoring

Delayed intervention ( 8 months of control period followed by 8 months with the intervention)

ACTIVE COMPARATOR

Usual care for 8 months, consisting in rheumatology visits scheduled every 3-6 months. Followed by the intervention for 8 months: 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.

Other: Nurse-led telehealth remote self-monitoring

Interventions

Nurse-led telehealth remote self-monitoring OTHER

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.

Delayed intervention ( 8 months of control period followed by 8 months with the intervention); Immediate intervention (for 16 months)

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Diagnosis of rheumatoid arthritis (RA) according to the ACR 2010 criteria
• Disease duration ≥ six months
• Who experienced a flare defined by an increase of the clinical disease activity index (CDAI) ≥ 4.5 or a DMARDs switch or addition within the preceding three months
• Understanding French or English

You may not qualify if:

• Inability to consent
• Inability to complete questionnaires
• No Internet access

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• The Arthritis Society, Canada: collaborator

Study Sites (4)

Hopital general de Montreal

Montreal, Quebec, H3H 1V6, Canada

Location

Centre de l'ostéporose et de rhumatologie de Québec

Québec, Quebec, G1V 2M1, Canada

Location

CHU de Quebec-Universite Laval

Québec, Quebec, G1V4G2, Canada

Location

Hopital Fleurimont et Hotel Dieu de Sherbrooke

Sherbrooke, Quebec, J1H 5H3, Canada

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Laetitia Michou, MD PhD

  CHU de Quebec-Universite Laval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laetitia Michou, MD PhD

CONTACT

+14185254444; laetitia.michou@crchudequebec.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One arm with immediate intervention for 16 months; and one arm with delayed intervention, i.e. usual care for 8 months (control period) followed by 8 months of intervention

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CA (4)