Rheumatoid arthritis Musculoskeletal Diseases
Conditions
Interventions
This trial is a non-commercial, continuous recruitment, short exposure stepped wedge cluster randomized controlled trial to determine whether the use of integrated symptom tracking is superior compare
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease activity is assessed using the DAS28-C-Reactive Protein (DAS28-CRP) at baseline and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Impact is measured using the difference in the proportion of participants meeting the EULAR response categories (Good, Moderate, Non-Responders) derived from disease activity score from the electronic health record at 12 months follow-up between the SoC and integrated symptom tracking conditions. 2. Patient-reported disease activity is measured using the: 2.1. Difference in RAPID-3 items total score at 12 months follow-up relative to initial (baseline) visit between SoC and integrated symptom tracking conditions. 2.2. Difference in patient global assessment from the REMORA2 web survey at 12 months follow-up relative to initial (baseline) visit between SoC and integrated symptom tracking conditions. 2.3. Difference in Rheumatoid Arthritis Impact of Disease (RAID) score from the REMORA2 web survey at 12 months follow-up relative to initial (baseline) visit between SoC and integrated symptom tracking conditions. 3. The difference in joint involvement and severity is measured via the Swollen Joint Count for 28 joints (SJC28) and the Tender Joint Count for 28 joints (TJC28) score taken from the electronic health record at 12 months follow-up relative to initial (baseline) visit between SoC and integrated symptom tracking conditions. 4. Medication use is extracted from the electronic health record at 12 months relative to initial level at first completion (baseline) between SoC and integrated symptom tracking conditions. 5. Work impairment is measured by the difference in Work Productivity and Activity Impairment Questionnaire (WPAI-RA) score as reported in the REMORA2 web survey at 12 months relative to initial level at first completion (baseline) between SoC and integrated symptom tracking conditions. 6. Quality of life is measured by the difference in the EuroQol five-dimension scale questionnaire (EQ-5D-5L) health profiles, index score and quality-adjusted life years gained as reported in the REMORA2 web survey at 12 months relative to initial level at first comple | — |
Countries
England, United Kingdom
Contacts
Public ContactDeb Griffiths-Jones
Outcome results
None listed