The best way of assessing if this service is practical and acceptable to patients and if it improves the care they receive, is through a Randomised Controlled Trial (RCT). RCT means that if you take part, you will have an approximately equal chance of receiving either of the options being compared: Group 1 (testing this new service) or Group 2 (usual care). The decision about which option you will receive is random (i.e. based on chance). Participants will be given a reference number. The reference number will be used to allocate participants at random to Group 1 or Group 2. A computer system will be used for random allocation, which ensures that the groups of patients receiving the two options are similar. In this way, a fair comparison can be made between groups at the end of this trial. This process is called randomisation. Your GP will not have access to this process.
You will be allocated to Group 1 or Group 2 and your practitioner will inform you about your group allocation. Below there is a description of what the allocation in each group involves.
Participants in this group will:
â€¢ Be asked some questions about their medication taking behaviour by the health care practitioner
â€¢ Receive information about the text messaging/app service (information on how to use this service will be provided in a leaflet with a link to a video)
â€¢ Be asked about whether they prefer to test the intervention by using the text messaging service or the app
During three months of this study, you will be able to request to switch from the text message to the app, if you prefer so. The frequency and times of the messages will be decided during the appointment with the health care practitioner, and you will have the option to change these during three month service by contacting the research team. The messages will aim to provide advice and support for medication taking following your practice consultations (please see examples of text messages/app notifications at the end of this information sheet).
Participants in this group will:
â€¢ Continue receiving the usual care provided by their general practice, with no access to the text or an app service
Three and six months after allocation to groups, participants in both groups will be sent follow-up questionnaires and asked to attend the practice. During the practice meeting, the healthcare practitioner will take clinical measures (mentioned at the beginning of study).
Clinical measures collected at the beginning and at the end of the study will be sent to laboratories for analysis. The blood samples will be sent to the Addenbrookeâ€™s Hospital laboratory for measurement of HbA1c and cholesterol (lipoprotein: hdl, ldl). One urine sample will be taken and sent to the Leicester Hospital laboratory to measure concentration of anti-hypertensive medication in the urine. All the results will be sent to the research team directly.
At 3 months follow up only, we will select some patients from Group 1 and Group 2 and invite them to take part in a face-to-face or telephone interview to obtain their views about their experiences of using this service. This interview will last around 45 minutes.
What are the possible benefits of taking part?
We will use the information you give us to further develop this service to support people with high blood pressure or associated conditions (e.g. type 2 diabetes and cholesterol) to take their necessary medications as prescribed. We will also use this information to make recommendations to healthcare providers in general practices about how best to help people take their prescribed medications and achieve the relevant long-term health benefits. You may not benefit directly from this, but if successful, this may benefit other people with similar conditions, who do not take their medications as prescribed.
What are the possible risks of taking part?
This service will include advice and reminders about your medications. However, some people may not like being reminded about taking medications for a health condition, such as high blood pressure.
During the interview at the end of study, we will ask your views on this service. We will not ask you sensitive or personal questions. You can withdraw from this study at any time. If during the study, you became upset or report a potentially serious health concern or problem, we will ask you to contact your GP practice. Alternatively, with your permission, we will contact your GP practice on your behalf. For any of these cases, you should ask your GP.