The GLORIA adherence subproject: problems and randomization mistakes
Journal of Trial and Error, vol. 2, pp. 54–59
Abstract
Medication adherence, which is the extent to which patients take their medication as prescribed, is essential in treating chronic inflammatory diseases such as rheumatoid arthritis (RA). Therefore, we nested a subproject in the two-year multicenter Glucocorticoid Low-dose Outcome in Rheumatoid Arthritis (GLORIA) trial to add a low-dose prednisolone (5 mg/day) or placebo to the standard care in older people (≥65 years) with RA. Adherence was measured with an electronic monitoring cap that recorded bottle openings in all patients. In the subproject, we performed an adherence intervention with an advanced cap that could communicate with an application on the smart device via Bluetooth. We randomized patients with a smart device to receive or not to receive adherence reminders on the smart device for three months. Multiple problems emerged that precluded an answer to the research question: sample size (overly optimistic estimates of older patients with a smart device), logistic issues (availability of smartcaps, data extraction), randomization and treatment allocation errors (despite training of personnel), and low quality of the data in the intervention group (hardware failure, discovered too late because data was read in batches). For future trials planning to include a subproject, we recommend keeping it simple, starting with a field test before the actual study starts, and monitoring data from the beginning of the study.
Authors 14
-
Linda M. Hartman corresponding
Amsterdam University Medical Centers · Vrije Universiteit Amsterdam · Amsterdam UMC Location Vrije Universiteit Amsterdam
Affiliation as printed
Amsterdam UMC
Amsterdam Rheumatology and Immunology Center, Amsterdam UMC, location VUmc, Amsterdam, Netherlands
Epidemiology & Data Science, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands
-
Affiliation as printed
Maasstad Hospital
Department of Rheumatology and Clinical immunology, Maasstad Hospital, Rotterdam, Netherlands
-
Affiliation as printed
Groene Hart Hospital
Department of Rheumatology, Groene Hart Hospital, Gouda, Netherlands
-
St. Antonius Ziekenhuis · Antonius Ziekenhuis
Affiliation as printed
Antonius Hospital
Department of Rheumatology, Antonius Hospital, Sneek, Netherlands
-
University Medical Center Utrecht
Affiliation as printed
University Medical Center Utrecht
Department of Rheumatology and Clinical Immunology, University Medical Center Utrecht, Utrecht, Netherlands
-
Affiliation as printed
Gelre Hospitals
Department of Rheumatology, Gelre Hospitals, Apeldoorn, Netherlands
-
Leiden University Medical Center
Affiliation as printed
Leids University Medical Center
Department of Rheumatology, Leids University Medical Center, Leiden, Netherlands
-
Affiliation as printed
Northwest Clinics
Department of Rheumatology, Northwest Clinics, Alkmaar, Netherlands
-
Affiliation as printed
Haga Hospital
Department of Rheumatology, Haga Hospital, Den Haag, Netherlands
-
Affiliation as printed
Tools Patient Empowerment
Tools Patient Empowerment, Amsterdam, Netherlands
-
Affiliation as printed
BeyonDevices LDA
-
Affiliation as printed
Bluepharma, Indústria Farmacêutica
-
Amsterdam University Medical Centers · Vrije Universiteit Amsterdam
Affiliation as printed
Amsterdam UMC
Epidemiology & Data Science, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands
-
Amsterdam University Medical Centers · Amsterdam UMC Location Vrije Universiteit Amsterdam
Affiliation as printed
Amsterdam UMC
Amsterdam Rheumatology and Immunology Center, Amsterdam UMC, location VUmc, Amsterdam, Netherlands
Cited by 3 stored of 4
3 results
No patents citing this paper on Lens.org (checked 2026-10-11).
References 4
4 results