(Cost-)effectiveness of electronic drug monitoring feedback in order to decrease non-adherence in RA-patients starting with biological DMARD - A randomised clinical trial at Reade

To reduce disease activity and ultimately limit the joint damage as much as
possible, DMARD-therapy (adequately taken by the patient) is warranted in the
early stage of RA. Interventions to improve adherence are therefore necessary
to reduce undesirable effects of non-adherence on health and medication costs.
The usage of drug monitoring devices (like Medication Event Monitoring System
(MEMS*)) combined with personal feedback regarding medication behavior has
proven in other diseases like HIV to be an effective strategy to improve
adherence and therefore clinical outcome, decrease drug changes and drug use.
Although these studies suggest that electronic drug monitor feedback might have
the potential to prevent unnecessary treatment escalation in rheumatoid
arthritis patients with poor adherence, empirical evidence to prove this
drug-/cost saving potential is lacking. Implementing electronic monitoring
feedback in RA might result in a cost effective strategy to reach earlier low
disease activity and a prolonged persistence with current biological DMARDs.

To determine if electronic drug monitoring adherence feedback in standard care
for patients with rheumatoid arthritis starting with a new biological DMARD is
effective on medication adherence compared to a usual care group. The second
objective is to examine the effect of the intervention on costs and time with
high disease activity.

Randomised, open clinical trial comparing electronic drug monitoring feedback
with standard care.

Patients in the intervention group receive their medication during 1 year in an
electronic device. Before each regular (3-monthly) consult to the
rheumatologist, patients medication adherence will be assessed by reading out
the electronic device and in case of non-adherence (<80% adherence) possible
barriers to medication intake will be discussed with the trained researcher/
-assistant on a semi-structured way. Patients in the control group will receive
standard care (an interview with the pharmacy consultant without electronic
drug monitor feedback).

Most patients are already invited for an interview about their medication use,
assessment of the disease activity and blood sampling prior to their regular
visit to the rheumatologist. The interview about patients medication is an
excellent moment for introducing, reading out and discussing the electronic
devices and their reports in this study. Electronic drug monitor feedback will
be combined with the assessment of patient*s actual medication use. One session
takes approximately 20-60 minutes each and is planned before each consult to
the rheumatologist (after 3,6,9 and 12 months). Participating in this study
needs just a little extra effort from the patient. The intervention program
does not constitute a risk for the participants.