Testing a serious puzzle game for medication adherence in Rheumatoid Arthritis patients

The primary outcome comprises the difference in proportion of non-adherent patients (less than 80% medication adherence) after three months in the intervention (serious game) group compared to usual care. Primarily, medication adherence will be measured using the Compliance Questionnaire for Rheumatology (CQR). The CQR presented good validity when compared to an electronic medication monitoring device over a period of six months [22]. Currently, the CQR is regarded as a reliable instrument to assess self-reported adherence in RA.

Medication adherence (based on pill count) after three months:

Medication adherence is difficult to measure, since there is no commonly agreed standard for adherence assessment. The primary outcome on adherence is subjective and it is preferred to also assess adherence using an objective outcome. Therefore medication adherence will be assessed using the method of pill/injection counting for a single ‘anchor’ DMARD, in addition to the CQR questionnaire. Therefore patients will be supplied with a set and surplus amount of medication at the start of the anchor drug. They will be asked to commit to using this stock only during the study. At the end of the study patients will be asked to bring the remainder to the pharmacy and a count will be performed.



Medication adherence (based on CQR) at one month

As the intervention, playing ‘Medi en Seintje’ is voluntary the exact exposure to the intervention during the study period cannot be predicted. In order to better assess whether the intervention has an effect and because mobile games like ‘Medi en Seintje’ are subject to user engagement for retention of play, medication adherence is also assessed at one month using the CQR.

Beliefs about Medication Questionnaire (BMQ) at baseline, one and three months
The Beliefs about Medicine Questionnaire (BMQ) is also used. The BMQ assesses both beliefs about the necessity of medication and concerns about medication.



Patient reported outcome (based on RADAI questionnaire) at baseline and three months

Apart from clinical disease activity, it also important to take the patient experienced disease load into account. The Rheumatoid Arthritis Disease Activity Index (RADAI) provides an easy to use patients assessment of RA disease activity.



The following secondary outcomes are part of usual care in the treatment of rheumatoid arthritis.



Physical Functioning at baseline and three months

Physical functioning will be measured with the 24-item Dutch version of the Health Assessment Questionnaire (HAQ).

Disease activity at baseline and after three months

Disease activity will be measured with the Disease Activity score (DAS28). The DAS28 is an assessment to RA disease activity as part of usual care. The DAS28 will be collected from the medical file if available at baseline or up to four weeks in advance. Likewise, the DAS28 will be collected at three months (plus or minus a maximum of four weeks) if available.

The outcomes on ‘Medi en Seintje’ only apply to the intervention group.

“Medi en Seintje” outcomes

To assess whether patients have been exposed to serious game “Medi en Seintje” the following outcomes from the application will also be collected:

• Installed on smartphone or tablet

• Number of log-in’s

• Average session time

• Total play-time at one and three months

• Exposure to ‘triggers’ (number of completed triggers for each type of trigger)

• Notifications on/off

“Medi en Seintje” satisfaction at three months

Besides the disease-related outcomes, it also important to know how subjects experience the intervention. After all, the intervention is software and therefore easily adopted to make it more effective or fit user needs better. Hence, ‘Medi en Seintje’ satisfaction will also be assessed at three months.