Driving improvements in disease outcomes for rheumatoid arthritis patients using digital health technology (Bio-T-App)

ISRCTN	ISRCTN79368292
DOI	https://doi.org/10.1186/ISRCTN79368292
Integrated Research Application System (IRAS)	236940
Protocol serial number	012369, IRAS 236940
Sponsor	Queen Mary University of London
Funders	Barts Health Charity, EPSRC - Pambeyesian: patient managed decision support using Bayesian networks.

Submission date: 03/01/2019
Registration date: 13/02/2019
Last edited: 20/05/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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?
November 2018 to May 2021

Who is funding the study?
Barts Health Charity

Who is the main contact?
The Chief Investigator: Prof. C. Pitzalis (c.pitzalis@qmul.ac.uk)
Principal Investigator at Mile End: Dr Fran Humby (f.humby@qmul.ac.uk)
EMR clinical trials team: (emrclinicaltrials@qmul.ac.uk )

Contact information

Dr EMR clinical trials team -
Public

Centre for Experimental Medicine & Rheumatology
William Harvey Research Institute
Barts and The London School of Medicine & Dentistry
2nd Floor, John Vane Science Centre
Queen Mary University of London
Charterhouse Square
London
EC1M 6BQ
United Kingdom

ORCID ID	0000-0002-8160-3131
Phone	+44 (0)20 7882 3497
Email	emrclinicaltrials@qmul.ac.uk

Dr Amy MacBrayne
Scientific

Centre for Experimental Medicine & Rheumatology
2nd Floor
John Vane Science Centre
William Harvey Research Institute
Barts and The London School of Medicine & Dentistry
Queen Mary University of London
Charterhouse Square
London
EC1M 6BQ
United Kingdom

Study information

Primary study design	Observational
Study design	Single centre prospective observational pilot study
Secondary study design
Study type	Participant information sheet
Scientific title	Driving Improvements in disease outcomes for rheumatoid arthritis patients using digital health remote sensing (Bio-T-App): an observational pilot study
Study acronym	Bio-T-App
Study objectives	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(s)	East of Scotland Research Ethics Service, 18/09/2018, ref. 18/ES/0102.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	18/05/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Total final enrolment	60
Key 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
Key exclusion criteria	N/A
Date of first enrolment	16/11/2018
Date of final enrolment	31/12/2019

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Mile End Hospital

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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Other files	Final report	03/01/2023	03/01/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version 6.0	07/07/2020	03/01/2023	No	No

Additional files

ISRCTN79368292_Protocol_V6.0_07Jul2020.pdf: Protocol file
ISRCTN79368292_Final report_03Jan2023.pdf: Final report

Editorial Notes

20/05/2024: A study contact was updated.
03/01/2023: The following changes have been made:
1. Protocol file uploaded.
2. The overall trial end date has been changed from 30/06/2020 to 18/05/2021 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 30/06/2021 to 31/12/2023.
4. The public contact has been changed and the plain English summary updated accordingly.
5. A final report has been added to the trial outputs.
05/12/2022: The final enrolment number has been added.
18/02/2020: The following changes have been made:
1. The recruitment end date has been changed from 30/11/2019 to 31/12/2019.
2. The overall trial end date has been changed from 31/12/2019 to 30/06/2020 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 31/07/2019 to 30/06/2021.
4. The IRAS number has been added.
5. The scientific contact has been added.
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.