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

Country of recruitment: The Netherlands



SUMMARY

Rationale: Effectiveness of pharmacological therapy in inflammatory rheumatic diseases may be limited by inadequate patient adherence to medication. Interventions to improve adherence of DMARDs are therefore necessary to reduce undesirable effects of non-adherence on disease activity, joint damage and overall healthcare costs. Games are increasingly used to address behavioural and psychological factors associated with adherence to medical treatment regimens. Nevertheless, no serious game, where the main goal is providing entertainment, has ever been deployed to subtly and positively influence medication adherence behaviour.

Objective: This study aims to examine the effectiveness of serious game “Medi en Seintje” to improve medication adherence and clinical outcomes in patients with rheumatoid arthritis treated with Disease Modifying Anti-Rheumatic Drugs (DMARDs).

Study design: The effectiveness of this serious game will be assessed in a randomised clinical multicentre trial comparing the serious game intervention to traditional care.

Study population: Adults diagnosed with rheumatoid arthritis treated with Disease Modifying Anti-Rheumatic Drugs

Intervention (if applicable): The intervention group will be asked to install and play a puzzle game on their tablet or mobile phone. Playing the puzzle game is encouraged at the start of the study but otherwise completely voluntary.

Main study parameters/endpoints: The main study parameter is adherence. Primarily this is assessed using the validated Compliance Questionnaire for Rheumatology (CQR). Additionally, a pill count will be performed and the Beliefs About Medicine Questionnaire will be collected. Secondary clinical outcomes are the Health Assessment Questionnaire (HAQ) and the self-reported Rheumatoid Arthritis Disease Activity Index (RADAI). DAS-28 will be gathered if available. Lastly, game experience on the puzzle game will be assessed.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: It has been shown that merely measuring adherence already leads to an increase in adherence. An increase in medication adherence is likely to improve disease outcomes for patients. The intervention itself is voluntary, considered to be fun and no adverse events are to be expected. The burden for patients during a period of three months consists of a total of thirteen extra questionnaires.

This study aims to examine the effectiveness of serious game “Medi en Seintje” to improve medication adherence and clinical outcomes in patients with rheumatoid arthritis treated with Disease Modifying Anti-Rheumatic Drugs (DMARDs).

1 and 3 months

Puzzle game 'Medi & Seintje' available on smartphone or tablet. Intervention patients can play at will.