Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 10:09 PM
Study NCT ID:
NCT05332158
Status:
UNKNOWN
Last Update Posted:
2022-08-26
First Post:
2022-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Medicines Gaps Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Researcher will be blinded to participants with pseudonymised data being collected for analysis.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-24', 'studyFirstSubmitDate': '2022-01-18', 'studyFirstSubmitQcDate': '2022-04-11', 'lastUpdatePostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Charge from baseline adherence rates at 6 months', 'timeFrame': 'baseline, 6 months', 'description': 'Barriers 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.'}, {'measure': 'Frequency of reported adherence barriers', 'timeFrame': 'immediately after the intervention', 'description': 'Commonly reported and less commonly reported barriers as a percentage of all responses'}], 'secondaryOutcomes': [{'measure': 'Response rate, demographic and geographic variation', 'timeFrame': 'immediately after intervention', 'description': 'Response rates in the integrated questionnaires within primary care systems'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adherence', 'barriers', 'anticoagulants', 'statins'], 'conditions': ['Adherence, Medication', 'Statin Adverse Reaction', 'Anticoagulant Adverse Reaction']}, 'descriptionModule': {'briefSummary': '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.\n\nDuring 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).\n\nApart 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients\n* having an active repeat prescription for a DOAC and/or a statin for at least 6 months prior to the date of data extraction\n* 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)\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT05332158', 'acronym': 'MeGa', 'briefTitle': 'Medicines Gaps Study', 'organization': {'class': 'OTHER', 'fullName': 'The Leeds Teaching Hospitals NHS Trust'}, 'officialTitle': 'The Adherence to Oral Anticoagulants and Statins Project', 'orgStudyIdInfo': {'id': 'PH21/145969'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'A single arm to administer questionnaires for patients barriers to adherence.', 'interventionNames': ['Behavioral: Questionnaires to report barriers to medication adherence']}], 'interventions': [{'name': 'Questionnaires to report barriers to medication adherence', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS1 3EX', 'city': 'Leeds', 'state': 'West Yorkshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Emmanouela Kampouraki, PhD', 'role': 'CONTACT', 'email': 'mymedsurvey.lth@nhs.net', 'phone': '0113 3926856'}], 'facility': 'Leeds Teaching Hospitals Trust', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'centralContacts': [{'name': 'Emmanouela Kampouraki, PhD', 'role': 'CONTACT', 'email': 'mymedsurvey.lth@nhs.net', 'phone': '0113 3926856'}], 'overallOfficials': [{'name': 'Emmanouela Kampouraki, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Leeds Teaching Hospitals Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Leeds Teaching Hospitals NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Leeds Clinical Commissioning Group', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}