Feasibility of a smartphone app for increasing medication adherence
| ISRCTN | ISRCTN96168767 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96168767 |
| Secondary identifying numbers | 2.0; 41380 |
- Submission date
- 23/04/2018
- Registration date
- 15/03/2019
- Last edited
- 03/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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 August 2021 (updated 08/06/2021, previously: July 2021 (updated 09/03/2021, previously: June 2021 (updated 04/09/2020, previously: December 2020)))
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Prof. Stephen Sutton
Contact information
Scientific
Institute of Public Health
School of Clinical Medicine
Box 113 Biomedical Campus
Cambridge
CB2 0SR
United Kingdom
| Phone | +44 (0)1223330594 |
|---|---|
| srs34@medschl.cam.ac.uk |
Public
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
| Phone | +44 (0)1223 768272 |
|---|---|
| jj285@medschl.cam.ac.uk |
Study information
| Study design | Parallel-group randomized feasibility trial with individual allocation to three arms |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Community |
| Study type | Treatment |
| 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 |
| 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(s) | 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 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Medisafe app |
| 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 study start date | 01/10/2017 |
| Overall study end date | 14/08/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 102; UK Sample Size: 102 |
| Total final enrolment | 106 |
| 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 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 | 14/05/2021 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
United Kingdom
Sponsor information
University/education
School of Clinical Medicine
Cambridge
CB2 0SZ
England
United Kingdom
| Website | http://www.cam.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/013meh722 |
Hospital/treatment centre
Lockton House, Clarendon Road
Cambridge
CB2 8FH
England
United Kingdom
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 03/01/2024 | 03/01/2024 | No | No |
Additional files
Editorial Notes
03/01/2024: Basic results added.
13/03/2023: The intention to publish date was changed from 31/03/2023 to 30/06/2023.
07/12/2022: The intention to publish date was changed from 31/12/2022 to 31/03/2023.
22/09/2022: The intention to publish date was changed from 30/09/2022 to 31/12/2022.
10/05/2022: The intention to publish date has been changed from 31/05/2022 to 30/09/2022.
14/02/2022: The intention to publish date was changed from 28/02/2022 to 31/05/2022.
09/12/2021: The intention to publish date was changed from 31/12/2021 to 28/02/2022.
12/10/2021: The intention to publish date was changed from 14/10/2021 to 31/12/2021.
11/08/2021: The following changes have been made:
1. The intention to publish date has been changed from 31/08/2021 to 14/10/2021.
2. The total final enrolment number has been changed from 104 to 106.
08/06/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/06/2021 to 14/05/2021.
2. The overall end date was changed from 31/07/2021 to 14/08/2021.
3. The intention to publish date was changed from 31/07/2021 to 31/08/2021.
4. The plain English summary was updated to reflect these changes.
5. The total final enrolment was added.
09/03/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/03/2021 to 01/06/2021.
2. The overall end date was changed from 01/06/2021 to 31/07/2021.
3. The intention to publish date was changed from 01/06/2021 to 31/07/2021.
4. The plain English summary was updated to reflect these changes.
04/09/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/09/2020 to 01/03/2021.
2. The overall end date was changed from 01/12/2020 to 01/06/2021.
3. The intention to publish date was changed from 01/03/2021 to 01/06/2021.
4. The plain English summary was updated to reflect these changes.
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.
