No registrations found.
ID
Source
Brief title
Health condition
Rheumatoid Arthritis
Sponsors and support
Intervention
Outcome measures
Primary outcome
DAS 28 & Number of outpatient clinic visits
Secondary outcome
Patient satisfaction (10-point Likert scale), patient empowerment (Effective consumer scale), Disease activity (Rapid 3), Treatment satisfaction (TSQM-9), medication adherence (CQR5), Healthcare Participation (WPAI), Overall Costs (Tic-P), Adherence (Questionnaire completion rates), Qualitative Data, App usability (System Usability Scale)
Background summary
Rising health care costs, increasing elderly population and shortage of personnel force us to think about alternative ways to organize our health care system. Telemedicine with self measurement of disease activity could be one of the key ingredients of the health care system of the future. The SeMoRa-3 study is a single blinded randomized controlled trial (RCT) in which patients with Rheumatoid Arthritis (RA) monitor their own disease activity with the help of a smartphone application. Patients randomized to the intervention group receive instructions, a username and a password for the MijnReumaReade smartphone app. They are instructed to complete weekly questionnaires and one outpatient clinic visit is planned at the end of the trial period. Additional follow up visits are scheduled on the basis of flares as recognized by the app or at the requests of individual patients. Patients in the standard care group continue their routine follow up visits as deemed necessary by the rheumatologist. Ultimately, the hypothesis is that after one year the disease activity is the same in both groups and the health care utilization will decline in the intervention group.
Study objective
(1) patient self-monitoring is not inferior to standard of care in terms of DAS 28 score;
(2) patient self-monitoring in RA patients will reduce outpatient clinic visits, and will consequently decrease healthcare costs.
Study design
First inclusion may 2019, all patients included 2nd quarter 2020, all patients completed study 2nd quarter of 2021.
Addendum: due to the COVID-19 outbreak inclusion was stopped in april 2020 at 103 patients. With the new power analyses the non-inferiority limit has been set to 0.5. The study will have been completed by all patients by the end of april in 2021.
Intervention
Self-monitoring of disease activity combined with self initiated care
Inclusion criteria
• Diagnosed with RA by a rheumatologist
• Disease duration of at least 2 years
• Low disease activity or remission (DAS28 < 3,2) at moment of inclusion
• Taking a disease-modifying anti-rheumatic drug (DMARD)
• Own a mobile device with an Android or iOS operating system (implying mobile phone literacy)
• At least 18 years old
• Able to read and speak Dutch
Exclusion criteria
• Medication change: start or stop of a DMARD (biologicals, or conventional DMARDS*) in the last 6 months.
• Is taking part in another intervention study
* Methotrexate, cyclosporine, cyclophosphamide, gold injections, hydroxychloroquine, leflunomide, mycophenolate, sulfasalazine, corticosteroids.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7715 |
| Other | METC Vumc : 2018.646 |