Title: A novel smartphone app for increasing medication adherence in patients prescribed antihypertensive medication in a community pharmacy setting: Randomised feasibility study
Funder: Department of Health and Social Care

Abstract: Background Almost eight million people in England receive treatment for hypertension. Many of these patients have co-morbidities such as type 2 diabetes, coronary heart disease and stroke. Taking medication as prescribed can significantly reduce risks, complications and early deaths associated with these conditions. However, a substantial proportion of these patients do not take their medications as prescribed. Non-adherence to medications in people with long-term conditions is a serious problem that is not currently addressed in the NHS. Non-adherence reduces the effectiveness of treatment and increases the cost to the NHS from hospital admissions, additional consultations, referrals, investigations and medicine wastage. Community pharmacists can support patients in taking their medication but they have limited time. One solution is to use low-cost, digital interventions designed to support medication adherence between pharmacy visits. We have developed a new smartphone app called Healthera to help patients take their medication. The pharmacist or dispensing technician tells the patient about the app when the patient collects their medication. The pharmacist prints a label and sticks it on the box of medications. The patient downloads the app to their smartphone and scans the label. This automatically transfers information about the medication to the patient s phone and sets up reminders. The enhanced version of the app also supports two-way communication between the patient and the pharmacist. Aims The aim of the proposed research is to assess the feasibility and acceptability of the two versions of the app (the interventions ) and the feasibility of conducting a future cost-effectiveness trial. This will include estimating key uncertain trial parameters such as recruitment rate, uptake and use of the interventions, and follow-up rate. The research questions are: 1. Are the interventions feasible and acceptable? 2. Is it feasible to conduct a future trial of the cost-effectiveness of the interventions? Plan of investigation Design A parallel group randomised controlled trial with individual allocation to three arms: (1) Control: an existing reminder app (MediSafe); (2) Basic version of the Healthera app; (3) Enhanced version of the Healthera app. Participants 102 patients prescribed antihypertensive medication recruited from six independent community pharmacies in the East of England. Baseline After introducing the study and obtaining informed consent, the pharmacist or dispensing technician will measure the patient s blood pressure and randomise them. For patients allocated to either of the two intervention arms, the instruction label on the box of medication will include a QR code for the participant to scan after they have downloaded the Healthera app. Follow-up Three months later, the participant will be invited back to the pharmacy for measurement of outcomes including: systolic blood pressure (this will be the primary outcome in the main trial); medication adherence assessed by prescription refill, pill count and self-report; EQ5D-5L, health service costs and resource use. Feasibility measures will include participation rate, intervention uptake rate and follow-up rate. Qualitative interviews 18 patients and six pharmacists/technicians will be interviewed to gain insights into their experience of the intervention and taking part in the trial. Benefits to patients and the NHS The cost per patient for an intervention of this kind is likely to be low. If shown to be cost-effective in a full trial, the intervention could be rapidly implemented in the NHS, with immediate benefits to patients and to the health service. Benefits to patients include improved blood pressure control, reducing risk of complications and preventing condition-related events such as heart attack, stroke and transient ischaemic attack. Benefits to the NHS include reduced hospital admissions, consultations, referrals, investigations and medicine wastage, saving an estimated &pound;100 million a year. The findings are likely to be generalisable to other patient groups.

Lay abstract: About eight million people in England receive treatment for high blood pressure. They include many people with other conditions such as type 2 diabetes, coronary heart disease and stroke. Treatment for high blood pressure usually consists of one or more blood pressure lowering medicines. Taking medication as prescribed can significantly reduce risks, complications and early deaths associated with these conditions. However, many people with these conditions do not take their medication as prescribed. This reduces how well such treatment works. It also means that a lot of medicines are wasted, which costs the NHS several hundred million pounds a year. Community pharmacists can support patients in taking their medication but they have limited time. There is therefore a need for low-cost solutions for helping patients to take their medication as prescribed. A promising approach is to use digital solutions such as smartphone apps . We have developed a new smartphone app to help patients take their medication. The pharmacist (or another member of the pharmacy team) tells the patient about the app when the patient collects their medication. The pharmacist prints a label and sticks it on the box of medications. The patient downloads the app to their smartphone and scans the label. This automatically sends information about the medication to the patient s phone and sets up reminders. The patient can also use the app to send messages to the pharmacist and to receive replies from the pharmacist. We will test two versions of the app in 102 people who are prescribed blood pressure lowering medication. We want to find out whether the app might work to help patients take their medication as prescribed and whether patients like using it. If the results are encouraging, we plan to test the effectiveness of the app in a large randomised controlled trial.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: CARDIOVASCULAR