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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN79368292

Enrollment

Registered

2019-02-13

Start date

2018-11-16

Completion date

Unknown

Last updated

2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis Musculoskeletal Diseases Rheumatoid arthritis, unspecified

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: N/A

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

England, United Kingdom

Contacts

Public ContactEMR clinical trials team -

emrclinicaltrials@qmul.ac.uk+44 (0)20 7882 3497

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026