Condition category
Musculoskeletal Diseases
Date applied
03/01/2019
Date assigned
13/02/2019
Last edited
03/07/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The Bio-T-App is a mobile phone app that is downloaded to a persons’ phone, laptop or tablet. The aim of the Bio-T-App study is to evaluate the Bio-T-App as a tool to facilitate remote monitoring of RA disease activity. It is believed that increased monitoring will help to reduce symptoms and disease flares. The study will achieve this by supporting patients to submit regular joint counts via the app and examining regular blood tests. A cohort of patients using the app will be compared to a cohort of patients in routine care. This will allow us to determine whether it is possible to customise the treatments we provide to individual patients.

Who can participate?
Participants will be eligible to participate in the study if they are men or women older than 18 years who have been diagnosed with Rheumatoid Arthritis and are not currently in high disease activity (DAS <5.1). 30 participants will be recruited to the Bio-T-App arm of the study and will need access to a smartphone/tablet or laptop. 30 participants will be recruited to the routine care cohort and will not need access to the app. These patients will be observed in routine care.

What does the study involve?
For patients in the Bio-T-App arm, at screening, baseline and at 6-month time point participants will attend a clinic visit. At baseline patients will undergo physical assessment and be shown how to use the app and complete a self-assessment joint count. Following baseline visit, participants will submit a joint count via the app each time they take their medication. This will be either weekly, fortnightly or monthly depending on which medication they take. At 3-months there will be a telephone consultation with the Clinical Research Nurse who will discuss participant care and disease management. Participants who are in the control arm will not have interaction with the app. Control patients will be recruited and will be observed in routine care only. At the study exit, both cohorts of patients will be asked to complete a patient satisfaction questionnaire.

What are the possible benefits and risks of participating?
The level of risk in the study is low. Participants who use the app may encounter technical difficulties. The research team will assist participants to download the app and set it up at baseline visit. Training will be provided and follow-up phone calls will help identify, support and resolve any technical issues. For patients, there will be the benefit of regular on-going support through the research team. Patients will benefit from an educational element focused on understanding disease activity scores in Rheumatoid arthritis.

Where is the study run from?
The study is sponsored by Queen Mary University. Patients will be recruited and seen at Mile End hospital, London. Mile End hospital is the only study centre.

When is the study starting and how long is it expected to run for?
The study will run for 1 year with a 6- month recruitment period and a 6-month follow up period. The study opened on the 14th November 2018

Who is funding the study?
Barts Health Charity

Who is the main contact?
The Chief Investigator: Prof. C. Pitzalis (c.pitzalis@qmul.ac.uk)
Principle Investigator at Mile End: Dr Fran Humby (f.humby@qmul.ac.uk)
Study Coordinator : Mrs Isabelle Garvey (i.garvey@qmul.ac.uk)

Trial website

Contact information

Type

Public

Primary contact

Mrs Isabelle Garvey

ORCID ID

Contact details

Centre for Experimental Medicine & Rheumatology
John Vane Science Building
Queen Mary University of London
Charterhouse Square
London
EC1M 6BQ
United Kingdom
020 7882 2111
i.garvey@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

012369

Study information

Scientific title

Driving Improvements in disease outcomes for rheumatoid arthritis patients using digital health remote sensing (Bio-T-App): an observational pilot study

Acronym

Bio-T-App

Study hypothesis

Evaluate the integration of a bespoke mobile app (Bio-T-App) for remote monitoring of RA patients by self-assessment as a reliable tool to measure RA disease activity.

Ethics approval

East of Scotland Research Ethics Service, 18/09/2018, ref. 18/ES/0102.

Study design

Single centre prospective observational pilot study

Primary study design

Observational

Secondary study design

Trial setting

Hospitals

Trial type

Other

Patient information sheet

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

Condition

Rheumatoid Arthritis

Intervention

Participants will receive either Bio-T-App or routine care. Patients will not be randomised. 30 patients will be recruited to Bio-T-App arm and following this 30 patients will be recruited to routine care arm and will not have any interaction with the app.

Participants on the Bio-T-App arm will have clinic visits at baseline, 12 weeks (telephone consultation) and 6 months. At every medication time point the patient will submit a joint count via the app. The clinical research nurse will submit recent blood results to calculate the patients disease activity. The control arm of the patient will have no encounter with the app and will progress through routine care as normal. At the end of the study (6 month time point) patients in both arms will complete a satisfaction questionnaire.

Intervention type

Other

Phase

Drug names

Primary outcome measure

The proportion of patients who adhere to the study schedule by recording disease activity scores (DAS28) which will be measured over a six month period from baseline.

Secondary outcome measures

1. The number of patients in low disease activity (defined as DAS <3.2) in Bio-T-App group v's routine care group will be measured using DAS28 score at 6 months.
2. The validity of submitted scores when evaluated against other clinical parameters of disease activity and overall clinical picture will be measured using blood results, DAS28 scores, medical history and reported symptoms at each joint count submission point.
3. Health economic impact will be measured using a comparison of biologic drug cost and number of outpatient visits in Bio-T-App group versus routine care at 6 month time point.
4. Patient satisfaction in Bio-T-App group versus routine care will be measured using a non-validated patient satisfaction questionnaire at 6 months.

Overall trial start date

05/01/2018

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged >18 years
2. Diagnosis of rheumatoid arthritis
3. Baseline DAS score <5.1
4. Access to smart phone/tablet/laptop to access the app
5. Prescribed a subcutaneous biologic drug for rheumatoid arthritis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

N/A

Recruitment start date

16/11/2018

Recruitment end date

30/11/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Mile End Hospital
Rheumatology Research Bancroft Road Mile End
London
E1 4DG
United Kingdom

Sponsor information

Organisation

Queen Mary University of London

Sponsor details

Joint Research Management Office
5 Walden Street
London
London
E1 2EF
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Barts Health Charity

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

EPSRC - Pambeyesian: patient managed decision support using Bayesian networks.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The improvements delivered by the Bio-T-App will be disseminated at different levels:
1. The results will be presented to local commissioners to implement a risk share agreement for the trust to ensure ongoing funding for Bio-T-App maintenance. In addition the results will be presented to the regional network of rheumatology consultants to support implementation of the Bio-T-App to the netwoek of hospitals within Barts Health and to local trusts.
2. Nationally/internationally - The data analysis will be presented at the Regional British Rheumatology Society Meeting and at National Pharmacy conferences (e.g Clinical Pharmacy Congress) as well as at a future date at International meetings including American-College-Rheumatology (ACR) and European League against Rheumatism (EULAR).

IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/07/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/07/2019: The recruitment end date was changed from 30/06/2019 to 30/11/2019. 15/03/2019: The following changes have been made: 1. The recruitment end date has been changed from 02/02/2019 to 30/06/2019. 2. The overall trial end date has been changed from 25/07/2019 to 31/12/2019.