Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-17 @ 12:14 AM
Study NCT ID:
NCT01823757
Status:
UNKNOWN
Last Update Posted:
2014-08-28
First Post:
2013-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmaceutical Care in VA Nursing Home
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010593', 'term': 'Pharmaceutical Services'}], 'ancestors': [{'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-27', 'studyFirstSubmitDate': '2013-03-29', 'studyFirstSubmitQcDate': '2013-03-29', 'lastUpdatePostDateStruct': {'date': '2014-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'quality of life measure', 'timeFrame': 'one year', 'description': 'use health outcome measure, EQ-5D, to assess the quality of life issue.'}], 'primaryOutcomes': [{'measure': 'potential inappropriate medication (PIA)', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'drug items used', 'timeFrame': 'one year', 'description': 'the controlled group is expected to have less drug items used.'}, {'measure': 'medical expenditure', 'timeFrame': 'one year', 'description': 'subjects self-reported outpatients visit, hospitalization, drug, and healthy supplemental used.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['elderly', 'potential inappropriate medications', 'pharmaceutical care', 'quality of life', 'medical expenditure'], 'conditions': ['Focus on the Elderly in a Nursing Home']}, 'descriptionModule': {'briefSummary': 'This study investigates the effect of pharmaceutical care on a Veteran nursing home. 100 patients will be selected into this controlled study.The hypothesis are:\n\n1. After patients receive pharmaceutical care, their drug related problems will be decreased.\n2. After patients received pharmaceutical care, their self-reported medical expenditure will be decreased.', 'detailedDescription': 'Around 200 residents in a Veteran nursing home will be selected for reviewing inclusion and exclusion criteria. A total of 100 subjected are selected into this randomized controlled trial. Each group will have 50 subjects and then divides into 4 subgroup, according to their drug items used (5-7 and over 8 items used).\n\nThe inclusion criteria:\n\n1. Residents of the Veteran nursing home.\n2. over 65 years old.\n3. complete comprehensive geriatric assessment (CGA)\n4. prescription drugs more than 4 times/day, excluding stat order.\n5. with 2 or more chronic diseases.\n\nExclusion criteria:\n\n1\\. residents who were in the pharmaceutical care project of Taiwan Pharmacists Association.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Resident from a Veteran nursing home and willing to receive the pharmaceutical care by pharmacists.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Residents in the Veteran nursing home\n* Age over 65 years old\n* Complete Comprehensive Geriatric Assessment (CGA)\n* Use more than 4 drug item per day (excluding stat order)\n* subjects with more than 2 chronic diseases.\n\nExclusion Criteria:\n\n* subjects who were in pharmaceutical care project of Taiwan Pharmacist Association.'}, 'identificationModule': {'nctId': 'NCT01823757', 'briefTitle': 'Pharmaceutical Care in VA Nursing Home', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Veterans General Hospital'}, 'officialTitle': 'The Impacts of Pharmaceutical Cares on the Elderly in a VA Nursing Home.', 'orgStudyIdInfo': {'id': 'VGHTCPHARMACY1'}, 'secondaryIdInfos': [{'id': 'TCVGHPHARM_RESEARCH_1', 'type': 'OTHER', 'domain': 'Taichung Veteran General Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-pharmaceutical care', 'description': 'Veterans do not receiving pharmaceutical care'}, {'label': 'Pharmaceutical care', 'description': 'Veterans receiving pharmaceutical care', 'interventionNames': ['Other: Pharmaceutical care']}], 'interventions': [{'name': 'Pharmaceutical care', 'type': 'OTHER', 'description': 'pharmacists provide pharmaceutical care to the intervention group, comparing to ordinary care in control group', 'armGroupLabels': ['Pharmaceutical care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changhua', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'Changhua Domiciliar Center', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}], 'overallOfficials': [{'name': 'Wen-Shyong Liou, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taichung Veteran General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}