A randomised controlled trial to improve treatment adherence in people with type 2 diabetes mellitus (INTENSE): A progress report
Medication non-adherence is a common problem among people with type-2 diabetes mellitus (T2DM), and is associated with increased hospitalisation and healthcare costs. Interventions developed to enhance medication adherence rarely allow for significant tailoring to individual need. This study aims to investigate the (cost-) effectiveness of a personalised intervention program to improve medication adherence in people with T2DM who are non-adherent to oral antidiabetic and/or antihypertensive medicines.
The study was designed for the Netherlands and adapted for a UK population through working with a patient and public involvement (PPI) group and relevant stakeholders. This is a 1:1 parallel-group, cluster randomised controlled trial conducted in community pharmacies in both countries. The target recruitment is 300 participants (150 per country) with six months of follow-up. Eligible patients in England are smartphone users aged 35 to 75 years with T2DM, non-adherent to oral antidiabetic and/or antihypertensive medicines and able to read and write in English. Community pharmacies and associated general practices are being approached to participate. General practices identify and invite potentially eligible patients who are later recruited by their pharmacy. Participants are asked to complete a questionnaire pack at baseline comprising an adherence profiling questionnaire, medication adherence report scale, diabetes treatment satisfaction questionnaire, beliefs about medicines questionnaire, and quality of life questionnaire. They are then randomised using electronic 1:1 block randomisation per pharmacy into an intervention or control group. Intervention group participants have a consultation with a pharmacist whereas control group participants have a consultation with a pharmacy assistant. Due to COVID-19, remote consultations are being conducted. Intervention group participants are offered a range of personalised supporting programs as informed by their responses to the adherence profiling questionnaire, these include smart messages and/or completing an online self-help application. Usual care and access to a general T2DM website is provided to the control group.The primary outcome is change in medication adherence measured by telephone pill count. Secondary outcomes include change at six months in blood pressure, HbA1c, quality of life and healthcare costs.
Two meetings with PPI members were conducted and patient-facing supporting programs were adapted to suit the UK population. Several medical practices and their most proximal community pharmacies have expressed interest in the study and three sites are currently recruiting participants. Thirteen patients (54% males) with a median age (IQ) of 66 years (62-71) have been recruited. Of these participants, five have been randomised into the intervention group and eight into the control group. Recruitment of new sites is ongoing.
The study will report the impact of a personalised adherence intervention on diabetes-related health, health-related quality of life and healthcare costs.