Improving treatment adherence in people with diabetes mellitus (INTENSE)

Conference:

SAPC ASM 2020 - cancelled due to pandemic

Talk Code:

I.1

Presenter:

Hiyam Al-Jabr

Twitter:

@Twitter for @HiyamAljabr

Co-authors:

Hiyam Al-Jabr1, Marlous Langendoen-Gort2, Jacqueline G Hugtenburg3, Femke Rutters4, Maartje de Wit5, Amber A van der Heijden2, Frank Snoek5,6, Andrew Farmer7, Petra JM Elders2, Debi Bhattacharya1

Author institutions:

1 University of East Anglia, 2 Department of General Practice and Elderly Medicine, Amsterdam UMC (VUmc); 3 Department of Clinical Pharmacology and Pharmacy, Amsterdam UMC (VUmc); 4 Epidemiology and Biostatistics Department, Amsterdam UMC (VUmc); 5 Department of Medical Psychology, Amsterdam UMC (VUmc); 6 Department of Medical Psychology, Amsterdam UMC (AMC); 7 University of Oxford

Problem

Medication 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 effectiveness and cost effectiveness of a personalised intervention program to improve medication adherence in people who are non-adherent to oral antidiabetic and/or antihypertensive medicines.

Approach

The study was designed for the Netherlands and adapted for a UK audience through working with a patient and public involvement (PPI) group and other relevant stakeholders including the local pharmaceutical committee. The one to one parallel-group, cluster randomised controlled trial will be conducted in community pharmacies in the Netherlands and the UK. A total of 300 participants will be recruited (n=150 per country) and followed-up for six months. Eligible patients are smartphone users aged 35 to 75 years with T2DM. They must be non-adherent to oral antidiabetic and/or antihypertensive medicines and able to read and write in English.

Screening and recruitment will be undertaken in two stages: 1. Potentially eligible patients will be identified by medical practice database searches. The results will be screened by a GP and a letter posted to potentially eligible patients inviting them to contact their community pharmacy team for recruitment. 2. Patients expressing interest in participation will be screened by a member of the pharmacy team to confirm eligibility.

Electronic 1:1 block randomisation per pharmacy will be used to randomise patients to intervention or control. Patients will complete an adherence profiling questionnaire to inform generation of a personalised intervention program for intervention participants. This may comprise a selection from text messages, medication dispensing systems and referral to a prescriber. The control group will receive usual care plus access to a general T2DM website.

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. A process evaluation including interviews and focus groups with patients, pharmacists and prescribers will be used to understand the trial findings. NHS ethical approval has been secured.

Findings

Three medical practices and their most proximal community pharmacies have expressed an interest in participating in participant identification and recruitment. Two meetings with PPI members were conducted, and patient-facing supporting programs were adapted to suit the UK population. Participant recruitment is expected to start in April 2020.

Consequences

The study is expected to demonstrate the impact of a personalised adherence intervention on diabetes-related health, health-related quality of life and healthcare costs.

Submitted by:

Hiyam Al-Jabr

Funding acknowledgement:

We would like to thank the European Foundation for the Study of Diabetes for funding this study