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Medicines Gaps Study

The Adherence to Oral Anticoagulants and Statins Project

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05332158
Acronym
MeGa
Enrollment
3000
Registered
2022-04-18
Start date
2022-05-30
Completion date
2022-09-30
Last updated
2022-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adherence, Medication, Anticoagulant Adverse Reaction, Statin Adverse Reaction

Keywords

adherence, barriers, anticoagulants, statins

Brief summary

The adherence project aims to understand adherence rates and barriers to Direct oral anticoagulants (DOACs) and statins and improve awareness of healthcare professionals on adherence across Leeds. During the first component of the project, the investigation of rates of non-adherence was classed as service evaluation. The second component of this project, which this IRAS application refers to, will look into patient perspectives and barriers to adherence. Currently, such information is not routinely collected and only requested as part of shorter or longer consultations depending on a pre-defined clinical agenda and with little attention to adherence. Two specific questionnaires have been designed and integrated within the primary care medical records systems. Following invitation for target patients on DOACs and/or statins to respond anonymously, responses to the questionnaire(s) will be stored in their medical records. Data will then be extracted from the two systems \[SystmOne and Egton Medical Information Systems (EMIS)\] using unique system identifiers, that will be pseudonymised at the time of extraction. All patient pseudonymised information (including medical records system identifiers and responses to the questionnaire) will be extracted by the LTHT Researcher-Pharmacist following access provided by each participating General Practitioner (GP) Practice, based on searches built centrally by the Data Quality Team of the Leeds Clinical Commissioning Group (CCG). Apart from the dissemination of findings based on the questionnaire, a training package for health professionals will be designed and delivered. The aim of the training is to combine and disseminate all findings of the project, raise awareness on real-world non-adherence prevalence and the common barriers to adherence, demonstrate the usefulness of routine adherence estimation and suggest tools to address non-adherence in daily practice. The objectives of this training will also consider the training needs of healthcare professionals locally, as per the healthcare professionals survey that has been designed and circulated.

Interventions

BEHAVIORALQuestionnaires to report barriers to medication adherence

One questionnaire specific to DOACs and one specific to statins have been integrated within the medical records system and will be sent to eligible patients to respond to following written informed consent.

Sponsors

Leeds Clinical Commissioning Group
CollaboratorUNKNOWN
The Leeds Teaching Hospitals NHS Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

Researcher will be blinded to participants with pseudonymised data being collected for analysis.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adult patients * having an active repeat prescription for a DOAC and/or a statin for at least 6 months prior to the date of data extraction * a diagnosis of atrial fibrillation (AF) for those on a DOAC and of hypercholesterolemia for those on a statin (to justify the preventive nature of the treatments)

Exclusion criteria

* Patients with an active repeat prescription for a DOAC and/or a statin for less than 6 months prior to the date of data extraction

Design outcomes

Primary

MeasureTime frameDescription
Charge from baseline adherence rates at 6 monthsbaseline, 6 monthsBarriers to DOAC and statin adherence that patients have chosen to disclose in the dedicated questionnaires. The rates of adherence based on repeat prescription data following the use of questionnaire(s) will also be compared with the individual rate before the use of questionnaire.
Frequency of reported adherence barriersimmediately after the interventionCommonly reported and less commonly reported barriers as a percentage of all responses

Secondary

MeasureTime frameDescription
Response rate, demographic and geographic variationimmediately after interventionResponse rates in the integrated questionnaires within primary care systems

Countries

United Kingdom

Contacts

Primary ContactEmmanouela Kampouraki, PhD
mymedsurvey.lth@nhs.net0113 3926856

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026