Condition category
Musculoskeletal Diseases
Date applied
30/07/2019
Date assigned
28/10/2019
Last edited
28/10/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Rheumatoid arthritis (where joints become swollen because the body’s defence systems attack them) affects 1% of the UK population. Rheumatoid arthritis is a life-long incurable disease and symptoms change over time.

Current medical treatment of rheumatoid arthritis is based on pre-arranged hospital appointments, sometimes many months apart. Currently, the only way for patients to tell their rheumatology doctor how their arthritis is, is at routine hospital appointments or by requesting an additional emergency appointment.

Flare-ups in inflammatory activity occur in many patients with rheumatoid arthritis and are unpredictable. Flares can last for days or weeks and cause significant disability and impact on activities of daily living. Identifying flares quickly and starting appropriate treatment is recommended within standard care and can improve symptoms and reduce a flare’s duration. However, it is often difficult for patients to be reviewed by a rheumatology specialist doctor quickly because rheumatology clinics are often fully booked. This means that the rheumatoid arthritis disease activity may worsen further before the patient can be seen by a rheumatology specialist.

This research project will use patient reported symptom severity scores, grip strength and image-recognition data (gathered from photos of hands taken by patients on their smartphones), collected through a secure smartphone app, to see if patient reported flares relate to clinician assessed flares in clinic.

Who can participate?
Patients with a diagnosis of rheumatoid arthritis, a smartphone and an email address will be eligible to take part.

What does the study involve?
This research project will last 16 months and be conducted within the rheumatology outpatient clinics at the Royal National Hospital for Rheumatic Diseases (RNHRD)/Royal United Hospital Bath (RUH). Patients will be asked to complete regular questionnaires about their rheumatoid arthritis disease activity via their smartphone, to record which joints they feel are tender and/or swollen, and measuring grip strength using a specialist grip-strength monitor. A subset of patients will also be required to take regular photos of their hands. If they experience a flare, patients will be asked to repeat these measures. They will then be reviewed within three working days by a rheumatologist who will examine their joints and make any treatment changes required.

What are the possible benefits and risks of participating?
Benefits: participants will receive additional contact time with clinicians as part of the 3 monthly data collection appointments and have a fast-track appointment should a flare occur. Participants may receive closer clinical monitoring and management of their rheumatoid arthritis, providing timely care which may not ordinarily have occurred. Furthermore, participants will benefit from being able to view a record of their condition’s variability as they populate the information fields across the study duration.
Risks: participants may need to visit the hospital for more appointments than they would normally and these will be during normal working hours. Additional blood sample at each visit may occur more often if your appointments were previously less than every 3 months. Participants will be required to spend time each week for a duration of 12 months answering questionnaires on a smartphone application, checking which joints are swollen and sore, and using the dynamometer to measure grip strength in each hand each.

The smartphone application is already used in the NHS and data is encrypted before being transferred to the company and then again before being made available to clinicians. The app is compliant with GDPR and meets the NHS Information Governance Toolkit regulations.
The use of the technologies involved is low risk. Both the dynamometer and smartphone data collection presents no danger to patients, beyond the potential physical hazard risk posed by these devices.

Where is the study run from?
Royal National Hospital for Rheumatic Diseases, UK

When is the study starting and how long is it expected to run for?
July 2019 to September 2020

Who is funding the study?
Innovate UK

Who is the main contact?
Dr Saion Chatterjee
saion.chatterjee@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr Saion Chatterjee

ORCID ID

Contact details

Royal National Hospital for Rheumatic Diseases (RNHRD)
Bath
BA1 1RL
United Kingdom
+44 1225 465941
jane.carter14@nhs.net

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

260182; CPMS 42212

Study information

Scientific title

Remote Early Flare Detection for Rheumatoid Arthritis (REFDRA)

Acronym

REFDRA

Study hypothesis

Does remote patient-reported flare assessment of rheumatoid arthritis agree with clinician flare assessment?

Ethics approval

Approved 03/07/2019, South West-Frenchay Research Ethics Committee (Bristol HRA Centre, Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT; 0207 104 8041; nrescommittee.southwest-frenchay@nhs.net), ref: 19/SW/0092

Study design

Prospective, single centre cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Rheumatoid arthritis

Intervention

Remote data will be collected over a 12 month period using the Living With Rheumatoid Arthritis smartphone application, dynamometer and thermal camera (in a subset of patients). In addition to routine clinical assessment with validated measures, participants will have a musculoskeletal ultrasound examination of their hands and feet undertaken when they experience flare.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Agreement between patient assessment of flare (binary yes/no, reported in-app or in clinic) and a DAS28-CRP flare (yes/no) measured using Receiver Operator Curve (ROC) analysis. DAS28 flare is defined as an increase in DAS28 score of ≥1.2 from the most recent previous non-flare DAS28 score if it was <3.2, or an increase of ≥0.6 if the previous recorded non-flare DAS28 was ≥3.2. Agreement is defined as ≥0.7.

Secondary outcome measures

1. Agreement between patient and clinician reporting of objective and patient-reported flare components. These components align with the Core Domain’s identified by the OMERACT group and encompass pain, physical function, fatigue, stiffness and participation. See omeract.org.
1.1 Clinician reported measures include: DAS 28-CRP and its constituent elements (28 tender joint count (TJC), 28 swollen joint count (SJC), physician global health assessment), and ultrasound assessment for joint synovitis (greyscale and Doppler).
1.2 Patient-reported measures include: patient-reported TJC and SJC, patient global health assessment, Routine Assessment of Patient Index Data 3 (RAPID3), the Health Assessment Questionnaire Disability Index (HAQ-DI), and grip strength (measured using a dynamometer in kg).
2. C-Reactive Protein (CRP) will be measured from blood drawn at time of clinical assessment, and a subset of patient will undergo thermal and photographic imaging of hands.

Overall trial start date

01/01/2019

Overall trial end date

30/09/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Can access and operate an Android or iOS operating system smartphone or tablet device
2. Access to the internet
3. An active email account
4. Capacity to consent to participate in the study
5. Able to attend face-to-face appointments 3-monthly and within three days of onset of a flare
6. Able to complete the remote monitoring according to the documented schedule
7. English language proficiency to use the smartphone application and complete remote data entry

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Fibromyalgia syndrome (FMS). The symptomatology of this condition can be a source of confounding of patient-reported outcome measures (PROMs) in rheumatoid arthritis.

Recruitment start date

15/07/2019

Recruitment end date

30/09/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal National Hospital for Rheumatic Diseases
Upper Borough Walls
Bath
BA1 1RL
United Kingdom

Sponsor information

Organisation

Royal United Hospitals Bath NHS Foundation Trust

Sponsor details

Royal National Hospital for Rheumatic Diseases (UK)
Upper Borough Walls
Bath
BA1 1RL
United Kingdom
+44 1225 465941
Not@pplicable

Sponsor type

Hospital/treatment centre

Website

https://www.gov.uk/government/organisations/innovate-uk

Funders

Funder type

Charity

Funder name

Innovate UK

Alternative name(s)

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The results of the study will be disseminated to participants if they have chosen to receive them when they are asked during the consent procedure.

The study results will be submitted to journals for publication and conferences for presentation.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

01/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/08/2019: Trial’s existence confirmed by HRA and Health and Care Research Wales (HCRW)