Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT01233193
Status:
UNKNOWN
Last Update Posted:
2016-05-06
First Post:
2010-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Pharmacist Intervention on Blood Pressure Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-05', 'studyFirstSubmitDate': '2010-10-29', 'studyFirstSubmitQcDate': '2010-11-02', 'lastUpdatePostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood pressure control', 'timeFrame': 'At 6 months', 'description': 'Percentage of patients with controlled hypertension'}], 'secondaryOutcomes': [{'measure': 'Adherence', 'timeFrame': 'At 6 months', 'description': 'Percentage of adherent patients after 6 months within the trial'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Home blood pressure measurement', 'Pharmaceutical Services', 'Medication adherence', 'hypertension management', 'Blood Pressure'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to test if a Pharmacist Intervention Program with home blood pressure monitoring (HBPM) improves or controls pharmacological adherence and blood pressure levels in hypertensive patients under pharmacological treatment, compared to those who receive usual care in a community pharmacy setting.', 'detailedDescription': 'Hypertension is a major health concern worldwide due to its deleterious impact on the population in terms of excessive morbidity and mortality, especially when there is insufficient hypertension control and prevention at the community level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both genders between the ages of 18 and 80 years, who access the pharmacy to fill their own prescription for hypertension.\n\nExclusion criteria:\n\n* Patient living with an other Hypertensive patient treated with the same medications\n* Pregnant women\n* Hypertensive patients with levels of systolic/diastolic blood pressure ≥ 180mmHg/110mmHg\n* Patient with secondary hypertension, kidney or liver failure\n* Patients already included in a care program for hypertensive patients\n* Patients with a new treatment for hypertension (less than 1 month)'}, 'identificationModule': {'nctId': 'NCT01233193', 'acronym': 'AFenPA', 'briefTitle': 'The Effect of Pharmacist Intervention on Blood Pressure Control', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': 'Pharmacist Intervention Effect on the Medication Adherence and Blood Pressure Control in Treated Patients', 'orgStudyIdInfo': {'id': 'DMM01-FAR-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'The intervention group receive an pharmacist intervention (health education, Home Blood Pressure Monitoring and Referral to physician as needed) This group will be followed for 6 months', 'interventionNames': ['Behavioral: Health education, Home blood pressure monitoring']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control group receive usual care in the community pharmacy'}], 'interventions': [{'name': 'Health education, Home blood pressure monitoring', 'type': 'BEHAVIORAL', 'otherNames': ['pharmaceutical health education'], 'description': 'Health education (on hypertension, smoking, healthy diet, obesity, physical inactivity and adherence to antihypertensive medications and home blood pressure monitoring) . The patient will be referred to physician when needed. The patient will be followed up during 6 months.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18000', 'city': 'Granada', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Community Pharmacies', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '23000', 'city': 'Jaén', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Community Pharmacies', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}], 'overallOfficials': [{'name': 'Maria Jose Faus, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad de Granada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'María José Faus Dáder', 'oldOrganization': 'Pharmaceutical Care Research Group of the University of Granada'}}}}