(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.
ID
Bron
Verkorte titel
Aandoening
Rheumatoid Arthritis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
DAS 28 & Number of outpatient clinic visits
Achtergrond van het onderzoek
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.
Doel van het onderzoek
(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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
Self-monitoring of disease activity combined with self initiated care
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL7715 |
Ander register | METC Vumc : 2018.646 |