Last reviewed · How we verify
NCT05332158: MeGa
Medicines Gaps Study
NA trial testing Questionnaires to report barriers to medication adherence in Adherence, Medication in 3,000 participants. Status unknown.
1 August 2022
Quick facts
| Lead sponsor | The Leeds Teaching Hospitals NHS Trust |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 3,000 |
| Start date | 30 May 2022 |
| Primary completion | 1 August 2022 |
| Estimated completion | 30 September 2022 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Questionnaires to report barriers to medication adherence
Conditions studied
- Adherence, Medication — all drugs for Adherence, Medication →
- Statin Adverse Reaction — all drugs for Statin Adverse Reaction →
- Anticoagulant Adverse Reaction — all drugs for Anticoagulant Adverse Reaction →
Sponsor
The Leeds Teaching Hospitals NHS Trust
Who can join
18 and older, any sex, with Adherence, Medication or Statin Adverse Reaction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05332158
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05332158 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Leeds Teaching Hospitals NHS Trust
- Last refreshed: 26 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05332158.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing