Using automatic medication dispensers to improve medication adherence for older adults with long-term conditions
| ISRCTN | ISRCTN18849739 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18849739 |
| IRAS number | 349006 |
| Secondary identifying numbers | IHREC1039 |
- Submission date
- 14/03/2025
- Registration date
- 31/03/2025
- Last edited
- 27/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English Summary
Background and study aims
This study aims to evaluate the effectiveness of a new automated medication dispensing device designed for people with long-term health conditions. The device provides reminders for taking medication and sends alerts to family members or carers if doses are missed. The goal is to determine whether the device can improve medication adherence and support overall health and wellbeing.
Who can participate?
Adults with long-term health conditions who take regular medication and sometimes struggle to manage their medication routine may be eligible to participate.
What does the study involve?
Participants will be randomly assigned to one of two groups:
A group using the automated medication dispensing device for six months.
A group continuing with their usual medication routine.
Participants may be asked to provide feedback through surveys or interviews to help researchers understand how the device fits into daily life.
What are the possible benefits and risks of participating?
Benefits:
Participants in the device group may find it easier to manage their medication.
The study contributes to research that could benefit others with similar conditions.
Risks:
There are no significant risks expected. Participants may need time to adjust to using the device.
Where Is the study run from?
University of Bedfordshire (UK)
When Does the Study Start and For How Long?
September 2024 to August 2026
Who is funding the study?
Bedford, Luton and Milton Keynes (BLMK) Integrated Care Research and Innovation Hub (UK)
NHS England
Who Is the Main Contact?
For further information or to express interest, individuals can contact:
Dr Jodi Emma Wainwright, jodiemma.wainwright@beds.ac.uk
Contact information
Scientific, Principal Investigator
University of Bedfordshire, University Square
Luton
LU1 3JU
United Kingdom
 ORCID ID |
0000-0003-4369-8202 |
|---|---|
| Phone | +44 1582 489217 |
| erica.cook@beds.ac.uk |
Public
University of Bedfordshire, Putteridge Bury
Luton
LU2 8LE
United Kingdom
| ORCID ID |
0000-0002-6297-499X |
|---|---|
| Phone | +44 7566729241 |
| jodiemma.wainwright@beds.ac.uk |
Study information
| Study design | Multicentre interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Pharmacy |
| Study type | Quality of life, Efficacy |
| Participant information sheet | 47004 PIS UoB_BLMK_ICS_AMD_Z-card_proof5.pdf |
| Scientific title | Assessing the impact of Automated Devices for enhancing HEalth and Reducing medication Errors in older Adults with long-term health conditions: A Randomised Controlled Trial |
| Study acronym | ADHERE |
| Study hypothesis | Are Automated Medication Devices (AMDs) for adults aged over 65 with long term health conditions, more effective than standard care in improving medication adherence, quality of life, and health status after six months? Which groups does it work best for, and why? |
| Ethics approval(s) |
1. Approved 13/03/2025, East of England - Essex Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8106; essex.rec@hra.nhs.uk), ref: 25/EE/0026 2. Approved 26/11/2024, Institutue for Health Research Ethics Committee (University of Bedfordshire, University Square, Luton, LU1 3JU, United Kingdom; +44 1234 400 400; EthicsIHR@beds.ac.uk), ref: IHREC1039 |
| Condition | Adults aged over 65 with long term health conditions |
| Intervention | There are two study arms, intervention and control. Each group will complete assessments at baseline, 3 and 6 months. The intervention group will receive the AMD and the control group will continue to take medication as normal. We will be sequentially allocating participants to trials arms taking in to account the covariates of interest. In this case, gender (Male vs Female), age (65-75 vs 75+), and the referral reason for entering the trial (Physical vs memory related) will be used to ensure that trial arms are balanced for these factors. Specially designed software will be used to manage this process called MinimPy2 |
| Intervention type | Device |
| Pharmaceutical study type(s) | Adherence to medication |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Pivotell Advance Automatic Pill Dispenser (Patent No. SE 535 462 C2) |
| Primary outcome measure | 1. Medication Refill Adherence (MRA) at baseline, 3 and 6 months 2. Self-report adherence data at baseline, 3 and 6 months 3. Adherence data for the intervention group will also be determined by using the Pivotell Administration Centre at 3 and 6 months |
| Secondary outcome measures | 1. Quality of Life 12-item Short-Form Health Survey (SF-12) at baseline, 3 and 6 months 2. Morisky Medication Adherence Scale (MMAS-8) at baseline, 3 and 6 months 3. Self-report healthcare resource use data at baseline, 3 and 6 months |
| Overall study start date | 01/09/2024 |
| Overall study end date | 31/08/2026 |
Eligibility
| Participant type(s) | Patient, Service user |
|---|---|
| Age group | Mixed |
| Lower age limit | 65 Years |
| Sex | Both |
| Target number of participants | 144 |
| Participant inclusion criteria | 1. Adults (≥65 years) 2. Diagnosed with at least one long-term health condition 3. Prescribed a stable daily medication regime and not taking medication more than four times per day 4. Has physical and/or memory-related difficulties taking medication and/or self-reported low medication adherence 5. And /or unsuccessfully tried other compliance aids, such as dosette boxes, calendar clocks, blister packs or talking labels. 6. Have sufficient English language skills 7. The patient provides written informed consent |
| Participant exclusion criteria | 1. Patients on cytotoxic medications (e.g. Methotrexate) 2. Clinically unsuitable medications or medications unsuitable for the AMD used (e.g., size, storage, administration method) 3. Variable medication regime (e.g. Warfarin) and/or taking medication more than four times per day 4. Patients who are already using an AMD or other similar electronic device. 5. Patients are not responsible for taking their own medications (e.g. carer administers medication). 6. The patient does not provide informed consent. |
| Recruitment start date | 01/03/2025 |
| Recruitment end date | 28/02/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Kingswood Way
Great Denham
Bedford
MK40 4GH
United Kingdom
Luton
LU4 8DE
United Kingdom
Marsh Farm Shopping Centre
The Moakes
Luton
LU3 3FH
United Kingdom
Hockwell Ring
Luton
LU4 9PG
United Kingdom
Houghton Regis
Dunstable
LU5 5ES
United Kingdom
Luton
LU4 0DU
United Kingdom
Luton
LU3 1HA
United Kingdom
Flitwick
Bedford
MK45 1DZ
United Kingdom
Sponsor information
University/education
Putteridge Bury
Luton
LU2 8LE
England
United Kingdom
| Phone | +44 1234 400 400 |
|---|---|
| gurch.randhawa@beds.ac.uk | |
| Website | https://www.beds.ac.uk |
"ROR" |
https://ror.org/0400avk24 |
Funders
Funder type
Other
No information available
No information available
Results and Publications
| Intention to publish date | 31/08/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | A dissemination planfor the ADHERE Trial will ensure that the findings are shared effectively with all relevant stakeholders, including healthcare professionals, researchers, patients, and the broader public. The dissemination plan will prioritise the timely release of results through peer-reviewed publications, conference presentations, and patient-oriented reports, adhering to ethical standards for transparency and accuracy. Data-sharing protocols will be established to promote secondary analyses while ensuring patient confidentiality. Engaging with patient advocacy groups and using accessible formats, such as lay summaries and digital media, will facilitate a more comprehensive understanding and application of the findings in clinical practice. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository: https://reshare.ukdataservice.ac.uk/ Anonymised data will be made available from the end of the trial for five years. This will include individual anonymised participant data and study publications including the study protocol, statistical analysis plan, health economics plan, and case report forms. Data from this study will be available via a sponsor-controlled application process for which applicants must show that they have sound scientific reasons for accessing the data and acceptable research methods. Consent for the sharing of anonymised data will be obtained from all study participants. At the culmination of the study, we plan to apply to share our anonymised data in a public repository such as the UK Data Archive https://reshare.ukdataservice.ac.uk/ where it would be accessible to other researchers. In order to enable this, we will highlight on our Participant Information Sheets and consent forms that anonymised data may be shared in this way. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 27/03/2025 | No | Yes |
Additional files
Editorial Notes
14/03/2025: Trial's existence confirmed by East of England - Essex Research Ethics Committee.
