Rheumatoid Arthritis
Conditions
Interventions
Puzzle game 'Medi & Seintje' available on smartphone or tablet. Intervention patients can play at will.
Sponsors
Sint Maartenskliniek
Eligibility
Inclusion criteria
Inclusion criteria: • diagnosis of RA (2010 ARA criteria [21] or clinical judgement by a rheumatologist); • use at least one DMARD that is dosed weekly or more frequent (in other words: all oral DMARDs and biological DMARDs injected weekly); • >18 years; • sufficient ability to understand Dutch; • be able to be followed for 3 months (life expectancy); • in possession of smartphone/tablet.
Exclusion criteria
Exclusion criteria: • cognitive and/or visual limitations that restrain the patient from playing the serious game (as assessed by the healthcare professional); • assistance in taking drugs (e.g. home care); • included in another trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Ques | — |
Contacts
Public ContactBart Pouls
Sint Maartenskliniek, Research department
Outcome results
None listed