A multi-centre randomised clinical trial to test the effectiveness of integrated symptom tracking in the management of rheumatoid arthritis

Not Applicable

• Conditions: Musculoskeletal Diseases; Rheumatoid arthritis

• Registration Number: ISRCTN51539448
• Lead Sponsor: niversity of Manchester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-04
• Last Update Posted: 18 June 2024
• Study Completion: 2026-03-15

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 931

Inclusion Criteria

TRIAL PARTICIPANTS
Healthcare professionals:
1. Has responsibility for the assessment and care of patients with RA
2. Has responsibility for treatment decision-making
3. Has access to the medical record at site as part of routine care
4. Is willing to review the REMORA dashboard during clinical interactions for consented patients
5. Is willing to provide full written informed consent

Patient trial participants:
1. Adult patients >=18 years of age (no upper age limit) with active definite or active probable RA, who are under the care of a consented health care professional. Active disease is defined by meeting at least one of the criteria below:
1.1. A DAS28 score of 3.2 or above recorded within 6 months of the baseline visit or as assessed at the baseline visit.
1.2. A change in Disease-Modifying Antirheumatic Drug (DMARD) or steroids administered in the last 6 months for RA.
1.3. Follow-up visits more frequently than annually i.e., anticipated to have at least one follow-up visit in the next 12 months from the baseline visit.
2. Own or have daily access to an Android or iOS smartphone or tablet with PIN code security, software version that supports the app, and the ability to access the internet daily to support data upload.
3. Regular access to a valid email address.
4. Have an NHS login account or is willing to create an NHS login account.
5. Have a medical record that can be viewed either by direct access or web-based access to the Greater Manchester Care Record (GMCR) (for patients in the Greater Manchester region) or the Whole Systems and Integrated Care (WSIC) tableau server (for patients in the North West London region).
6. Individuals who speak and understand English or can be supported by someone who can (if individuals have limited ability to read, speak, write or understand English they must have support from someone who can speak, read and understand English).
7. Can follow the requirements of the study independently or with support, including downloading the REMORA app onto a smartphone or tablet device.
8. Have capacity and are capable of providing full written informed consent.

INTERVIEWS
Patient interviews:
Recruitment target across clusters: up to 30 patients in usual SoC and 30 patients in the integrated symptom-tracking group
1. Patients eligible and consented to take part in the stepped wedge trial who are able and willing to be interviewed
2. Provide full informed consent either in writing or verbally before or at time of interview

Interviews with healthcare professionals, volunteers or professionals involved in the implementation of REMORA2

Healthcare professional interviews
1. Healthcare professionals working in a trial site who have indicated willingness to be interviewed
2. Provides full informed consent either in writing or verbally before or at time of interview

Non-REMORA2 healthcare professional interviews
1. Healthcare professionals working in a trial site who have declined to take part in the stepped wedge trial but have indicated willingness to be interviewed
2. Provides full informed consent either in writing or verbally before or at time of interview

Interviews of any professionals or volunteers involved in the implementation of integrated symptom tracking, including NHS staff
1. Any professionals or volunteers, including NHS staff, involved in the implementation of REMORA2 at a trial site, in collaborating organisations or within the community
2. Individual indicates willingness to be inte

Exclusion Criteria

TRIAL PARTICIPANTS
Healthcare professionals who:
1. Do not have responsibility for the assessment and care of patients with RA
2. Do not have responsibility for treatment decision-making
3. Do not have access to the medical record at site as part of routine care
4. Healthcare professionals who are not willing to participate in the stepped wedge trial and review the REMORA dashboard during clinical interactions
5. Do not provide full written informed consent

Patient trial participants:
1. Do not have definite or probable RA
2. Do not have active definite or active probable RA at the time of recruitment
3. Do not own or have daily access to a compatible smartphone device or tablet
4. Do not have or unwilling to add PIN code security on the device
5. Do not have access to an email address
6. Do not have or is unwilling to create an NHS login account
7. Do not have a medical record in the GMCR or WSIC platforms
8. Patients who do not understand relevant project information (despite support, if needed)
9. Patients who are unwilling or do not have the capacity to provide full written informed consent

INTERVIEWS
Patient interviews:
1. Patients have not consented to take part in the stepped wedge trial
2. Patients who are not willing to participate in an interview
3. Patients who are not able to understand the project information and reasons for participation (despite support, if needed and available)
4. Patients who have taken part in the REMORA2 feasibility study between January and July 2023
5. Patients who are unwilling or unable to provide full informed consent for interview

Healthcare professional interviews:
1. HCP who is taking part in the stepped wedge trial but is not willing to participate in an interview
2. Do not provide full informed consent

Non-REMORA2 health care professional interviews:
1. HCP declined to take part in the stepped wedge trial and is not willing to participate in an interview
2. Do not provide full informed consent

Interviews of any professionals or volunteers involved in the implementation of integrated symptom tracking, including NHS staff
1. Professionals or volunteers, including NHS staff, not involved in the implementation of REMORA2 at a trial site, in collaborating organisations or within the community.
2. Individual is not willing to participate in an interview
3. Does not provide full written informed consent

Participants in the interviews to identify barriers to digital inclusion:
1. Patients who are participating in the trial and have registered with the app
2. Patients who are not willing to participate in an interview
3. Patients who are not able to understand the project information and reasons for participation (despite support, if needed and available)
4. Patients who cannot speak and understand English and are unable to attend an interview without an individual for support who can speak and understand English
5. Patients who are unwilling or unable to provide full informed consent for interview

OBSERVATIONS
Patient observed clinics:
1. Patients who are not participating in the stepped wedge trial
2. Patients who are consented to take part in the stepped wedge trial but are not willing to be observed during a clinic consultation either in-person or remotely
3. Patients who are not able to understand the project information and reasons for participation (despite support, if needed and available)
4. Patients who are unwilling or unable to provide full written informed consent for observation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease activity is assessed using the DAS28-C-Reactive Protein (DAS28-CRP) at baseline and 12 months