Title: Feasibility of MAPS (Medication Adherence for Patient Support): A highly tailored text and voice messaging intervention to support medication adherence among patients with type 2 diabetes and/or hypertension in primary care
Funder: Department of Health and Social Care

Abstract: Background Adherence to medication can prevent complications, disability and premature death in people with type 2 diabetes (T2DM) and/or hypertension. However, substantial proportions of people with these conditions do not take their medications as prescribed. Primary care practitioners have limited time to support medication adherence in people with long-term conditions, and the NHS is currently under financial pressures. There is a need for low-cost interventions that support medication adherence between primary care consultations. In the proposed study we will develop and assess the feasibility of a new intervention that uses individually-tailored text messaging (SMS) and interactive voice response (IVR) to provide ongoing support for medication adherence to people with T2DM and/or hypertension, as an adjunct to the primary care consultation. During the consultation (e.g. an annual review), the practice nurse gives the patient information about the intervention and how to register (by sending a text message to the system). Based on information obtained from the participant on a baseline questionnaire and from query calls and messages sent to the participant during the intervention period, the participant will receive individually tailored messages designed to address both intentional and non-intentional non-adherence. The intervention is automated and interactive and relatively inexpensive to deliver. It could potentially provide a cost-effective way of delivering support for medication adherence to a large number of people, including those with limited access to health care. Aim: To develop and assess the feasibility of an automated, interactive and highly tailored SMS&IVR intervention to support medication adherence in people with T2DM and/or hypertension as an adjunct to primary care consultations. Objectives: Phase 1: To develop the intervention and finalise the design of the feasibility study. Phase 2: To assess the feasibility, acceptability, cost and potential efficacy of the intervention. Plan of investigation This study is informed by our ongoing developmental work, which includes: a systematic review of trials of interventions that have used text messaging (SMS) or interactive voice response (IVR) to support medication adherence in people with T2DM or hypertension; and face-to-face interviews with patients and nurses recruited in primary care. In Phase 1 of the proposed research, we will develop the intervention and finalise the design of the feasibility study, using stakeholder consultations and focus groups with patients to address key uncertainties about the intervention, design of the feasibility study, and recruitment, uptake and retention. In Phase 2, we will conduct a feasibility study in 100 people with T2DM or hypertension. The focus of this study is on feasibility (both of the intervention and of conducting an effectiveness trial with economic evaluation) rather than on efficacy. This will include estimating recruitment, intervention uptake and retention/attrition rates. However, we plan to measure relevant outcomes (self-reported and objective medication adherence; clinical outcomes: blood pressure and HbA1c; resource use and costs) and to randomise participants to intervention versus usual care. This will provide additional information on the feasibility of measuring these outcomes, the feasibility of the randomisation method and the potential efficacy of the intervention, all of which will inform a full trial of effectiveness and cost-effectiveness. Potential benefits to patients and the NHS Currently there are more than 10 million people in England with T2DM or hypertension. The annual cost attributed to medication non-adherence in these two conditions is estimated to be &pound;490 million. If effective, this intervention could yield the following benefits: 1. Increase the number of patients who take their medications as prescribed in the long term and achieve associated health benefits. 2. Reduce costs to the NHS from health complications and premature deaths associated with these conditions and waste in prescribing.

Lay abstract: More than 10 million people in England have type 2 diabetes or hypertension (high blood pressure). Taking medication as prescribed can significantly reduce risks, complications and early deaths associated with these conditions. But many people with these conditions do not take their medication as prescribed. GPs and nurses 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 automated telephone interventions. Text and voice messages can deliver personalised and tailored support over a period of time. With the help of patients, nurses and other researchers, we will develop such an intervention. In the patient s annual review, the practice nurse tells the patient about the intervention and how to get started. Based on the information they give, participants will be sent individually-tailored messages designed to address their main reasons for not taking their medication as prescribed. The intervention is automated and interactive and cheap to deliver. It could provide a cost-effective way of supporting medication adherence in a large number of people between their visits to the practice. We will test the intervention in 100 people with type 2 diabetes or high blood pressure from six general practices. We want to find out whether the intervention may help patients take their medication as prescribed and whether they like using it. If the results are encouraging, we plan to test the effectiveness of the intervention in a large randomised controlled trial. [This would compare two groups of people: a group who receive the new intervention and a control group who receive usual care. The decision about which group a person is assigned to will be made at random (that is based on chance) by a computer.]

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: CARDIOVASCULAR;METABOLIC AND ENDOCRINE