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 |
| IRAS number | 236940 |
| Secondary identifying numbers | 012369, IRAS 236940 |
- 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
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
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 |
| emrclinicaltrials@qmul.ac.uk |
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
| Study design | Single centre prospective observational pilot study |
|---|---|
| Primary study design | Observational |
| Secondary study design | |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a 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 | 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 study start date | 05/01/2018 |
| Completion date | 18/05/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Bancroft Road
Mile End
London
E1 4DG
United Kingdom
Sponsor information
University/education
Joint Research Management Office
5 Walden Street
London
London
E1 2EF
England
United Kingdom
"ROR" |
https://ror.org/026zzn846 |
|---|
Funders
Funder type
Other
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 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? |
|---|---|---|---|---|---|
| Other files | Final report | 03/01/2023 | 03/01/2023 | No | No |
| Protocol file | version 6.0 | 07/07/2020 | 03/01/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
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.
