Condition category
Circulatory System
Date applied
23/04/2018
Date assigned
15/03/2019
Last edited
15/06/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
About eight million people in England receive treatment for high blood pressure. 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. Community pharmacists can support patients in taking their medication, but they have limited time. A promising approach to help patients take their medication is to use low-cost digital solutions such as smartphone apps. This study is designed to test a new smartphone app (Healthera) that has been developed to help patients to take their medication, to find out whether the app might work to help patients take their medication as prescribed and whether patients like using it.

Who can participate?
Patients aged 18 and over who have been prescribed any type of blood pressure lowering medication and attend a participating community pharmacy in the East of England or London during the recruitment period

What does the study involve?
The pharmacist (or another member of the pharmacy team) tells the patient about the app when the patient collects their blood pressure medication at the pharmacy counter. The pharmacist then prints a label containing a QR code and attaches it to the box of medication. The patient downloads the app to their smartphone and scans the label containing the QR code. This automatically sends information about the medication to the patient’s phone and sets up a schedule of reminders. The patient can also use the app to send messages to the pharmacist and to receive replies from the pharmacist. Patients are randomly allocated to use one of two versions of the app (a basic version without two-way communication and a standard version permitting two-way communication with the pharmacist) or a control app (Medisafe). Interviews are also conducted with patients as well as pharmacy staff to try to understand their experiences around using the app and of participating in the study.

What are the possible benefits and risks of participating?
If the results of this study are encouraging, the effectiveness of the app will be tested in a larger trial. Participants may find using the app and receiving reminders to take their medication helpful. Participants will contributing to the development and evaluation of an intervention that has the potential to reach a large number of people and provide them with tailored, low-cost support to take their medication. Interviewed participants will have the opportunity to talk openly about their experiences of using the app, how it assists with medication taking and of participating in the study. Participants may benefit from knowing that data from this study could inform future research on improving adherence to blood pressure lowering medication. Risks are minimal although there is the possibility of inconvenience, discomfort or intrusion. The researchers have tried to minimise the time involved, while still allowing sufficient time for the procedures to be completed. Participants may find that the app irritating. However, the researchers need to assess the acceptability of the app and the extent to which users engage with it and find it helpful. Participants may withdraw from the study at any time. Some participants may experience discomfort with the blood pressure measurement, and others may prefer not to have their blood pressure measured. Again, this is a feasibility study, and the researchers need to assess the feasibility of the measurement procedures. The main burden with the interviews will be the time spent by participants but it will be made clear how long the interview with the patient and with the pharmacist will last. Interviewees will not be asked questions of a personal or sensitive nature. Participants will be able to stop the interview at any time if they wish.

Where is the study run from?
Community Pharmacies in East of England and London (not yet identified) (UK)

When is the study starting and how long is it expected to run for?
October 2017 to December 2020

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Prof. Stephen Sutton

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stephen Sutton

ORCID ID

Contact details

Institute of Public Health
School of Clinical Medicine
Box 113 Biomedical Campus
Cambridge
CB2 0SR
United Kingdom
+44 (0)1223330594
srs34@medschl.cam.ac.uk

Type

Public

Additional contact

Dr James Jamison

ORCID ID

Contact details

Behavioural Science Group
Primary Care Unit
Institute of Public Health
Forvie Site
University of Cambridge School of Clinical Medicine
Box 113 Cambridge Biomedical Campus
Cambridge
CB2 0SR
United Kingdom
+44 (0)1223 768272
jj285@medschl.cam.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2.0; 41380

Study information

Scientific title

A novel smartphone app for increasing medication adherence in patient's prescribed anti-hypertensive medication in a community pharmacy setting: a randomised feasibility trial

Acronym

Study hypothesis

To test the feasibility and acceptability of a smartphone app to improve medication-taking behaviour in patients prescribed anti-hypertensive medications.

Ethics approval

Approved 09/04/2019, North West – Liverpool East Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull St., Manchester, M1 3DZ, +44 (0)207 104 8235, nrescommittee.northwest-liverpooleast@nhs.net), ref: 19/NW/0120

Study design

Parallel-group randomised feasibility trial with individual allocation to three arms

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Condition

Adherence to anti-hypertensive medication

Intervention

Randomisation will be stratified by pharmacy using the method of random permuted blocks:

Control arm: Medisafe app
Intervention arm 1: Healthera medication reminder app with pharmacist communication function
Intervention arm 2: Healthera basic medication reminder app without pharmacist communication function

Duration of interventions will be 3 months. Follow-up will be at the end of the 3-month testing period and will consist of a 45-minute pharmacy visit.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measure

Measured at baseline and follow-up meeting (3 months):
1. The proportion of potential participants who cannot participate because of technology issues but who are otherwise eligible
2. Participation rate (the proportion of eligible patients who agree to take part)
3. The number of participants randomised (in total; per pharmacy; and per month)
4. The proportion of participants in each trial arm who download and install the App (uptake rate)
5. The proportion of participants in each trial arm who use the App for 1 week, 1 month and 3 months
6. The proportion of participants who attend the pharmacy for follow-up and provide complete outcome measures
7. The proportion who drop out, reasons for loss to follow-up

Secondary outcome measures

Measured at baseline and follow-up meeting (3 months):
1. Medication adherence measured using Medication Adherence Report Scale (MARS)
2. Systolic blood pressure
3. Health status measured using the EQ5D-5L
4. Resource use (additional visits to the pharmacist as a result of using the App) and health service costs (time taken by pharmacist to explain intervention) measured to inform the economic evaluation in the main trial
5. Use of the study interventions and potential mediators of their effects on medication adherence and systolic blood pressure
6. Feasibility/acceptability of the interventions and of conducting a cost-effectiveness trial using qualitative interviews post-trial

Overall trial start date

01/10/2017

Overall trial end date

01/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years of age and over
2. Prescribed any type of blood pressure lowering medication and attending a participating community pharmacy in the East of England or London during the recruitment period
3. Owns a smartphone (Android or iPhone)
4. Has a valid email address
5. Has an adequate understanding of verbal and written English
6. Is able to provide written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 102; UK Sample Size: 102

Participant exclusion criteria

1. Is using a pill organiser or similar medication reminder system
2. Is taking part in another research project on medication adherence

Recruitment start date

01/07/2019

Recruitment end date

01/09/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Community Pharmacies in East of England and London (not yet identified)
-
United Kingdom

Sponsor information

Organisation

University of Cambridge

Sponsor details

School of Clinical Medicine
Cambridge
CB2 0SZ
United Kingdom

Sponsor type

University/education

Website

http://www.cam.ac.uk/

Organisation

Cambridgeshire and Peterborough CCG

Sponsor details

Lockton House
Clarendon Road
Cambridge
CB2 8FH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Two papers from this investigation will be prepared for publication in peer-reviewed journals, reporting findings from the feasibility trial and interviews with trial participants and pharmacists. Findings will also be disseminated through national and international conference presentations and other scientific meetings.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/03/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

15/06/2020: The scientific contact details have been made publicly visible. 12/06/2020: A public contact has been added. 21/05/2020: The following changes have been made: 1. The recruitment end date has been changed from 28/02/2020 to 01/09/2020. 2. The overall trial end date has been changed from 01/04/2020 to 01/12/2020 and the plain English summary has been updated to reflect this change. 10/12/2019: The recruitment end date has been changed from 30/11/2019 to 28/02/2020. 04/11/2019: The recruitment end date has been changed from 30/10/2019 to 30/11/2019. 02/09/2019: The following changes have been made: 1. The recruitment start date has been changed from 01/04/2019 to 01/07/2019. 2. The recruitment end date has been changed from 01/09/2019 to 30/10/2019. 15/03/2019: Trial's existence confirmed by the NIHR.