Developing a tailored digital intervention to improve adherence to statin medications
| ISRCTN | ISRCTN62558470 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62558470 |
| IRAS number | 324941 |
| Secondary identifying numbers | 23SM8299, CPMS 58875, IRAS 324941 |
- Submission date
- 20/05/2024
- Registration date
- 31/05/2024
- Last edited
- 15/11/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Statins are a type of medication that helps to reduce the levels of "bad" cholesterol in the body, which in turn lowers the risk of heart attacks, strokes, and death. However, many patients do not take these medications as prescribed, making them less effective. Adherence to statins is lower compared to other long-term medications, with only 25% of patients continuing to take them as prescribed after 2 years. Within a year of being prescribed statins, 40-60% of patients stop taking them altogether.
The reasons for this are often factors that can be changed, such as worrying about side effects or forgetting to take the medication. Researchers have studied these factors, but more work is needed to understand why some groups, such as ethnic minorities and people from underprivileged backgrounds, have even lower adherence rates. Currently, there are no affordable interventions addressing patients' unique barriers and using psychological theory to improve statin adherence.
This study aims to create a new scalable intervention that is tailored to each individual and based on behavioural science frameworks to improve adherence to statins.
Who can participate?
Patients aged 18 years and over who are taking statins and healthcare workers from primary care
What does the study involve?
Patients will participate in a 45-minute interview online or in person, depending on their preference, to explore their barriers and facilitators to taking statins. The second part of the study will involve running six 2-hour workshops (in-person and online) with patients and healthcare workers to develop the intervention. Between workshops, stakeholders will assess if the intervention is feasible to implement in practice.
The intervention will then be user-tested with a small sample of participants for a short period of time. After trying the intervention, participants will complete a follow-up questionnaire on acceptability and intervention usage. They will also be invited to participate in a one-hour focus group to provide feedback on the intervention and co-design improvements.
What are the possible benefits and risks of participating?
Interviews, workshops and user testing might be time-consuming for participants. Therefore, interviews will be scheduled at a time and place to suit the participant or will be online if preferred. Workshops will be online or in-person during the early evening or working hours. Workshops will also have breaks and will last a maximum of two hours. For user testing, the intervention will be delivered for a short period of time with a survey that could be completed directly on participants’ phones. The focus group will be online or in-person, depending on the group’s preference and will last an hour. There is no reasonable expectation that any harm will arise from these activities.
Where is the study run from?
1. Imperial College London (UK)
2. Hammersmith & Fulham (H&F) Partnership GP Practices (UK)
When is the study starting and how long is it expected to run for?
November 2023 to November 2025
Who is funding the study?
1. NIHR Research for Patient Benefit (RfPB) programme (UK)
2. London Interdisciplinary Social Science Doctoral Training Partnership (LISS DTP) (UK)
Who is the main contact?
Dr Gaby Judah, g.judah@imperial.ac.uk
Contact information
Scientific, Principal Investigator
Imperial College London
10th Floor
QEQM Building
St Mary's Hospital
Praed Street
London
W2 1NY
United Kingdom
| Phone | +44 (0)203 3121962 |
|---|---|
| g.judah@imperial.ac.uk |
Scientific
Brook Green Medical Centre
Bute Gardens
Hammersmith
London
W6 7EG
United Kingdom
| Phone | +44 (0)207 471 3333 |
|---|---|
| d.wingfield@imperial.ac.uk |
Public
Imperial College London
10th Floor
QEQM Building
St Mary's Hospital
Praed Street
London
W2 1NY
United Kingdom
| Phone | +44 (0)203 3121962 |
|---|---|
| jr1322@ic.ac.uk |
Study information
| Study design | In-depth interviews, co-design workshops with patients and healthcare workers and user testing of tailored statin adherence intervention |
|---|---|
| Primary study design | Observational |
| Secondary study design | Qualitative study |
| Study setting(s) | GP practice, University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Promoting STatin Adherence with a Tailored Intervention |
| Study acronym | STATIN |
| Study hypothesis | This study aims to develop a scalable yet individually tailored intervention to improve adherence to statin medications using behavioural science frameworks. To achieve this aim, the following objectives will be pursued: 1. To identify key modifiable statin adherence factors among different patient groups. 2. To co-design a theory-based, scalable, individually tailored intervention to support statin adherence. 3. To conduct user testing to optimise the intervention |
| Ethics approval(s) |
Approved 07/11/2023, North East - York Research Ethics Committee (2 Redman Place, London, E20 1JQ, United Kingdom; +44 (0)207 104 8079; york.rec@hra.nhs.uk), ref: 23/NE/0192 |
| Condition | Dyslipidemias in patients taking statins |
| Intervention | The first part of the study will consist of 15-17 semi-structured interviews with patients. Under-researched populations will be targeted to identify key determinants across diverse groups of patients. Participants will be purposefully recruited to ensure representation from different adherence levels (low adherence, adherent, and never initiated) and demographics. A screening survey will be used to confirm diverse representation and guide targeted recruitment if needed. A topic guide based on the Theoretical Domains Framework (TDF) will guide the interviews. Inductive thematic analysis will be conducted and then identified themes will be mapped deductively onto the TDF domains. Results will be analysed iteratively, and more interviews will be conducted if saturation has not been reached within groups. Following the interviews, three sets of two workshops (6 workshops in total), each lasting 2 hours and each with approximately 8-12 participants, will be conducted. Workshops will take place in multiple formats (in-person, online, various times) to promote inclusivity. Similar to the interviews, participants will be purposefully recruited to ensure a diverse range of patients. The final set of workshops will include primary care staff to gain their input on intervention feasibility. The intervention will be user experience tested and refined throughout the process. Ten participants will receive the intervention within a short time frame with flexible adaptation over time. Participants trying the intervention will answer a brief survey to assess intervention usage. They will also be invited to participate in a one-hour focus group to provide feedback on the intervention and co-design improvements. The discussion will explore acceptability, how easy the service was to use, and any other aspects (technological or otherwise) that decreased engagement. |
| Intervention type | Other |
| Primary outcome measure | 1. Modifiable factors (barriers and facilitators) affecting adherence to statin medications measured using interviews based on Theoretical Domains Framework 2. Acceptability of intervention measured by focus groups based on Theoretical Framework of Acceptability at user testing 3. Usability of intervention measured using the System Usability Scale (SUS) questionnaire at user testing 4. Intervention engagement measured using digital log files at user testing |
| Secondary outcome measures | 1. Key statin adherence modifiable factors for different groups of patients measured by interviews 2. Self-reported statin adherence measured using the 3 item Likert scale from Voils 2012 at recruitment 3. Sociodemographic characteristics measured by pre-screening questionnaire at recruitment |
| Overall study start date | 01/11/2023 |
| Overall study end date | 12/11/2025 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 89 |
| Participant inclusion criteria | Patients: 1. Have been prescribed statins 2. 18+ years old Health professionals: 1. Clinical pharmacists, General Practitioners (GPs), practice nurses or healthcare assistants 2. Regularly prescribe statins, or consult with, or advise patients on their statin therapy |
| Participant exclusion criteria | Patients: 1. Age >18 years old 2. Pregnant women 3. Patients who have never been prescribed statins 4. Cognitive impairment 5. Severe life-limiting condition 6. Did not speak English if a translator cannot be arranged for them 7. Did not consent to participate Health professionals 1. Working only on secondary care 2. Without experience in prescribing statins, managing, or advising patients on following statin therapy |
| Recruitment start date | 10/01/2024 |
| Recruitment end date | 01/08/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
W2 1PG
United Kingdom
Richford Street
London
W6 7HY
United Kingdom
Sponsor information
University/education
Room 215, Level 2, Medical School Building
Norfolk Place
London
W2 1PG
England
United Kingdom
| Phone | +44 (0)207 594 1862 |
|---|---|
| cheuk-fung.wong@imperial.ac.uk | |
| Website | https://www.imperial.ac.uk/research-and-innovation/research-office/research-governance-and-integrity/ |
"ROR" |
https://ror.org/041kmwe10 |
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
No information available
Results and Publications
| Intention to publish date | 01/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Academic outputs published in open-access high-impact, peer-reviewed academic journals. The developed intervention will be shared with study participants, and everyone involved in co-design (email summary, and invitation to a demonstration meeting with a recording shared afterwards). Findings will be also presented at well-attended conferences, seminars and regular engagement activities for community groups, patients and carers. |
| IPD sharing plan | The datasets generated during and/or analysed in this study will be available upon request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 8 | 10/10/2024 | 15/11/2024 | No | No |
Additional files
Editorial Notes
15/11/2024: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file.
2. The participant level data sharing statement was added.
20/05/2024: Study's existence confirmed by the HRA.
