educAR: Validation of a Double Educational Strategy to Improve Therapeutic Adherence in Rheumatoid Arthritis.
Phase: NA
Conditions: Rheumatoid Arthritis
Sponsor: María Ahijón

educAR 
Validation of a strategy to improve therapeutic 
adherence in rheumatoid arthritis. 
 
Study protocol and statistical analysis plan 
Version: v2 27/12/2021 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol 
Study design: We have designed a cluster clinical trial of 6-month duration. 
Randomization and allocation: Fifteen centres will be randomised to receive 
access and instruction on the strategy or to continue standard care. Centre 
recruitment is on a voluntary basis, understanding that access to the 
educational tool will be delayed in case of being assigned to the control group. 
Intervention: The intervention is a web-based tool with educational and 
practical materials for the patient and for the physician (this part will be 
protected with a password during the duration of the trial). Physicians 
(prescribers or non-prescribers) in centres assigned to the intervention will be 
invited to be instructed on the materials (text, videos, checklists, calendars, 
etc). Control will be standard care. 
Accessible population: The study will be conducted in specialized care centres 
in Spain. Each centre will recruit 15 consecutive adult patients with 
rheumatoid arthritis (as stated in the clinical records), less than 2 years since 
diagnosis and living independently. 
Variables and measures: The primary outcome will be therapeutic adherence 
(patient-level), defined as a score ≥ 80% in the Compliance Questionnaire on 
Rheumatology (CQR) and in the Adherence Medication Scale (RAM). 
Secondary outcomes will be adherence to physical activity, a Mediterranean 
diet, lifestyle changes and disease activity. 
Statistical Analysis Plan 
Sample size: Accepting an alpha risk of 0.05 and a beta risk of 0.20 in a 
bilateral contrast, 79 patients per group are required, assuming that the initial 
proportion of adherent patients is 70% and at the end of the intervention, it 
would increase to 90% (only in the intervention group, in the control it would 
not change). A lost-to-follow-up rate of 25% has been estimated. 
If 10 centres are selected to have at least 5 clusters for each group, this would 
correspond, rounding up, to 16 patients per centre, or a total of 160 patients. 
Statistical analysis: The effect of the intervention on adherence to treatment 
will be refuted by the chi-square test and measured by relative risk (RR) and 
difference of proportions. 
The effect of the intervention on RA disease activity and on adherence to 
healthy habits will be refuted by Student´s t test and the effect will be 
measured by the difference of means. 

In all cases, statistical significance will be inferred at a value of p< 0.05