Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-01-04 @ 5:02 PM
Study NCT ID:
NCT01939860
Status:
COMPLETED
Last Update Posted:
2017-12-05
First Post:
2013-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Feasibility Study of the Impact on Blood Pressure Control of Supplementing Community Pharmacist Services With Structured Information on Blood Pressure and Its Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-04', 'studyFirstSubmitDate': '2013-09-03', 'studyFirstSubmitQcDate': '2013-09-05', 'lastUpdatePostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in systolic or diastolic blood pressure', 'timeFrame': '1 year (trial would be stopped at 26 weeks if it is not possible to recruit any further participants', 'description': 'Systolic and diastolic blood pressure will be measured and recorded in mm Hg using OMRON blood pressure monitors'}], 'secondaryOutcomes': [{'measure': 'change in the knowledge of hypertension', 'timeFrame': 'one year(trial would be stopped at 26 weeks if it is not possible to recruit any further participants)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'Hypertension is a major health problem, however its control is unsatisfactory. One of the reasons for such a high prevalence of this disease includes poor patient compliance to treatment. Approximately 30 % of newly diagnosed hypertensive patients stop taking their blood pressure medication by six months and 50% by 12 months.\n\nThe UK government is keen to encourage community pharmacists to play an active role in participation of services that can improve patient adherence to their medications. The New Medicines Service (NMS) and targeted Medicines Use Reviews (MUR) are established services which fund community pharmacists to review and explain medicine use to patients, with hypertension a common condition for which advice is given within these schemes. Within these schemes, advice is verbal and unstructured, with no specific written information provided on drugs or the disease being treated.\n\nThis study aims to determine whether structured information provided to participants verbally and in writing by community pharmacists about blood pressure and current medicine(s) within NMS and targeted MURs will be retained and will be associated with improved hypertension control. Participants will be recruited from people eligible for NMS and MURs and attending community pharmacies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1)18 or over 2) male or female 3) Have been started on any blood pressure medication\n\nExclusion Criteria:\n\n1)Patients with English language problems'}, 'identificationModule': {'nctId': 'NCT01939860', 'briefTitle': 'A Feasibility Study of the Impact on Blood Pressure Control of Supplementing Community Pharmacist Services With Structured Information on Blood Pressure and Its Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Warwick'}, 'orgStudyIdInfo': {'id': 'Warwick.123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual pharmacy care', 'description': 'Participants will not receive any structured written education on hypertension and its treatment'}, {'type': 'EXPERIMENTAL', 'label': 'usual pharmacy care plus structured information', 'description': 'Participants will be provided with validated verbal and written information on hypertension and its treatment, including information about class (es) of anti-hypertensive medication(s) used by each patient, and their common side-effects. The written material will be based on validated patient information leaflets from the British Heart Foundation and the Blood Pressure Association.', 'interventionNames': ['Other: Written and verbal patient education on hypertension and its treatment']}], 'interventions': [{'name': 'Written and verbal patient education on hypertension and its treatment', 'type': 'OTHER', 'armGroupLabels': ['usual pharmacy care plus structured information']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'J P Goes chemist', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Warwick', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student', 'investigatorFullName': 'Ejaz Cheema', 'investigatorAffiliation': 'University of Warwick'}}}}