Rheumatoid arthritis (RA) Musculoskeletal Diseases Rheumatoid arthritis, unspecified
Conditions
Interventions
All participants are asked to sign a consent form following a full explanation of the study. Eligible participants will be allocated to symptom tracking using the REMORA2 smartphone app. Patients will
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Across all participant groups, recruited individuals must have mental capacity to understand the study information provided and to give informed consent. Additional specific criteria for each participant group is provided below: Clinical Team members: Clinicians and nurses, at either of the participating centres, who have primary responsibility for the care of patients with RA or suspected RA. Patients: Participants in the feasibility study: 1. Adult patients (i.e. =18 years of age) with RA or suspected RA, who are under the care of a consented clinician 2. Own an Android or iOS smartphone, with the ability to access the internet daily to support data upload 3. Can speak and understand English or are supported by someone who can Participants in the interviews to identify barriers to digital inclusion: 1. Adult patients (i.e. =18 years of age) with RA or suspected RA, who are under the care of a consented clinician, and were approached to join the feasibility study but declined for any reason (including ill health), and/or their carers. Urdu-speaking participants in the interviews to identify barriers to digital inclusion: 1. Adult patients (i.e. =18 years of age) with RA or suspected RA, who are under the care of a consented clinician, who are Urdu-speaking only, and/or their carers. Participants in Electronic Health Record review-only: 1. Adult patients (i.e. =18 years of age) with RA or suspected RA 2. Under the care of a consented clinician 3. Has the mental capacity to consent Community group members: 1. Adult patients (i.e. =18 years of age) with RA or other rheumatic and musculoskeletal diseases (RMDs), who also self-identify as having experience of one or more of the following: more severe (or multiple) disabilities, are older people (aged over 75 years), people living in an area of high deprivation, people from Black And Minority Ethnic communities, or their carers.
Exclusion criteria
Exclusion criteria: Clinical Team members: 1. Individuals who do not have primary responsibility for the care of eligible patients, such as physiotherapists, occupational therapists, pharmacists or podiatrists will not be recruited to the study, as we do not depend on them for recruitment or data completion. Patients: 1. Recruited patients must feel well enough to take part and be able to understand the relevant project information (with support if needed, e.g. a translator for Urdu-speaking participants). Patients who do not meet these criteria will not be recruited. 2. No patients under 18 years. There is no upper age limit. 3. Patients and clinicians will be eligible whether their consultations are being conducted in-person or remotely. Community group members: 1. Participants must feel well enough to take part and be able to understand the relevant project information (with support if needed).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim of this study is to assess the feasibility of conducting a stepped wedge RCT comparing usual care to integrated symptom tracking in patients with rheumatoid arthritis. The researchers will use the results to refine the design and processes of the main stepped wedge RCT and sample size calculations, as appropriate. 1. Recruitment rate, defined as the number of eligible participants who consent to participate in the study within the 3-month recruitment window 2. Retention rate, defined as the number of eligible participants who remain in the study until the end of the follow-up window 3. Intervention uptake rates among consented participants will be determined in reference to the number of: 3.1. Consented participants who successfully complete app download (in the period from recruitment opening to the close of trial) 3.2. Consented participants who successfully initiate symptom tracking (defined as completing at least one symptom report within the first 14 days of app download. Assessed in the period from recruitment opening to the close of trial) 3.3. Consented participants who complete the question sets on a daily, weekly and monthly basis (in the period from recruitment opening to the close of trial) 3.4. Clinical consultations in which available graphs of the REMORA data are reviewed at 3 months and 6 months, as applicable This information will be used to evaluate the following continuation criteria, which will inform the decision to proceed to the full stepped wedge randomised controlled trial: 1. Recruitment of 15 or more consented participants per site and where symptom tracking is initiated in 70% or more of consented participants across both sites and where symptom data has been received on over 50% of possible days of tracking. Possible days of tracking defined from the first day of receiving a symptom-tracking report. 2. Completion of 80% or more of the Disease Activity Score-28 (DAS28) in face-to-face consultations or the Clinical Diseas | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Perceptions related to user experiences of using the app, integration of the data in clinical settings and implementation of the symptom tracking in clinical care. This will involve patient and clinician data. Individuals from diverse backgrounds will be included to determine if experiences of the intervention differ and identify any barriers to engagement and their possible causes. 2. How the patient-generated symptom data are discussed, how it influences decision-making processes and the impact on consultation length. This will involve clinic observations. 3. Patients' and carers' perceptions of managing and regularly tracking RA symptoms and their views and experience of using technology to manage health. Personal care arrangements, experiences of and access to digital healthcare technology and their views and expectations regarding the use, and perspectives on using a mobile phone to collect health data to support clinical care, as well as barriers to remote monitoring of symptoms will be examined. The secondary aim of this study is to explore patients’ and rheumatology specialists’ perspectives on the feasibility of delivering and using integrated symptom tracking and, via identification of barriers to digital inclusion among patients invited to the feasibility study and local community groups, to develop and refine supporting materials for a future trial accordingly. The outcome measures that will be evaluated within this feasibility study are as follows: 1. Disease activity measured using DAS28 in a face-to-face consultation or the CDAI (obtained remotely) at baseline, 3 months and 6 months where applicable. 2. Symptom tracking data will be collected via the app on a daily, weekly and monthly frequency 3. Daily questions are completed from the date of registering the app until the trial exit. The question sets completed on a daily basis include: 3.1. Pain on a scale visual analogue scale (VAS) of 0-10 3.2. Function on a VAS of 0-10 3.3. Fatigue on a VA | — |
Countries
England, United Kingdom
Contacts
Public ContactDeb Griffiths-Jones
Outcome results
None listed