Effectiveness of a pharmacy-led personalised intervention program aimed at improving adherence to oral diabetes and/or hypertension medication in people with type 2 diabetes

Aims/hypothesis: To evaluate the effectiveness of a personalised intervention program aimed at improving medication adherence in people with type 2 diabetes who are non-adherent to oral diabetes and/or hypertension medication, compared to usual care including access to a diabetes website, after a six-month follow-up. Methods: Parallel-group randomised controlled trial with six-month follow-up conducted in community pharmacies in the Netherlands and United Kingdom. People with type 2 diabetes, 35-75 years and non-adherent to oral diabetes and/or hypertension medication were recruited. The intervention group received the personalised intervention program and the control group received usual care and an informative diabetes website. The primary outcome was medication adherence measured by telephone pill count and secondary outcomes were self-reported medication adherence, systolic blood pressure and HbA1c level. Linear regression analysis and longitudinal mixed model analysis were performed to assess intervention effectiveness. Results: The study population comprised 68 participants, 66.2% men with a median age of 65.0 [Q1 to Q3 59.3 to 71.0] years. Linear regression analysis for the primary outcome medication adherence showed no significant effect of the intervention (B -0.014, 95% CI -0.17 to 0.14). In addition, no significant differences were found between the intervention and control group for self-reported medication adherence (OR 3.18, 95% CI 0.89 to 11.37) and systolic blood pressure (B -1.41, 95% CI -9.64 to 6.83). Finally, the intervention group did not show better HbA1c levels compared to the control group (B 0.68, 95% CI 0.44 to 0.92). Conclusions/interpretation: We did not observe a statistically significant difference, nor a clinically point estimate of difference, in medication adherence between the intervention and control group of a personalised intervention program aimed at improving medication adherence in people with type 2 diabetes who are non-adherent to oral diabetes and/or hypertension medication after six-months follow-up. We therefore do not recommend implementation of the intervention program in daily practice. Trial registry number: Registered in the Dutch Trial Register (Trial NL8747) and ISRCTN Registry ( ISRCTN36009809 ). Social media post: No effect of a personalised intervention program was observed on medication adherence in people with type 2 diabetes. Future studies should first focus on alternative recruitment methods for non-adherent people with type 2 diabetes, before the effectiveness of the intervention can be re-evaluated in a larger study sample. Keywords: Medication adherence, type 2 diabetes, intervention, pharmacy, effectiveness