Prior medication adherence of participants and non participants of a randomized controlled trial to improve patient adherence in cardiovascular risk management.

ABSTRACT

BACKGROUND: Poor medication adherence is a major factor in the secondary prevention of cardiovascular diseases (CVD) and contributes to increased morbidity, mortality, and costs. Interventions for improving medication adherence may have limited effects as a consequence of self selection of already highly adherent participants into clinical trials. METHODS: In this retrospective cohort study, existing levels of medication adherence were examined in self-decided participants and non-participants prior to inclusion in a randomized controlled study (RCT), evaluating the effect of an intervention to improve adherence. In addition, the non-participants were further divided into 'responders' and 'non responders'. All individuals had manifest cardiovascular disease and completed a questionnaire with baseline characteristics, the Beliefs about Medicines Questionnaire (BMQ) and the Modified Morisky Scale® (MMS®) as part of a regular screening program. A logistic regression was conducted to examine the relationship between study participation willingness, adherence level and the beliefs about medication. RESULTS: According to the MMS® the adherence level was comparable in all groups. In both (non)-participants groups, 36% was classified as high adherent; 46% participants versus 44% non-participants were classified as medium adherent and 19% of the participants versus 20% of the non-participants were low adherent (p = 0.91. The necessity concern differential (NCD) from the BMQ was 3.8 for participants and 3.4 for non-participants (p = 0.32). CONCLUSION: This study shows that adherence to medication and beliefs about medication do not differ between participants and non-participants before consenting to participate in an RCT. The study design seems not to have led to greater adherence in the study group.