Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-25 @ 2:04 PM
Study NCT ID:
NCT01291966
Status:
COMPLETED
Last Update Posted:
2011-02-09
First Post:
2011-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Intervention to Reduce Medication Errors and Improve Adherence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}, {'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003153', 'term': 'Community Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-08', 'studyFirstSubmitDate': '2011-01-26', 'studyFirstSubmitQcDate': '2011-02-08', 'lastUpdatePostDateStruct': {'date': '2011-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'medication errors in the patients', 'timeFrame': 'Baseline, 1, 3 and 6 months', 'description': 'Medication errors before and after the intervention in each group'}], 'secondaryOutcomes': [{'measure': 'Percentage of adherence', 'timeFrame': 'Baseline and 6 months', 'description': 'To measure adherence to treatment will use a combination of direct methods (counting of medication) and indirect tests are passed or self-reported compliance test Haynes-Sackett and Morisky-Green test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['medication errors', 'Patient Compliance', 'patient safety', 'polypharmacy'], 'conditions': ['Medication Adherence', 'Patient Compliance']}, 'referencesModule': {'references': [{'pmid': '25858633', 'type': 'DERIVED', 'citation': 'Moral RR, Torres LA, Ortega LP, Larumbe MC, Villalobos AR, Garcia JA, Rejano JM; Collaborative Group ATEM-AP Study. Effectiveness of motivational interviewing to improve therapeutic adherence in patients over 65 years old with chronic diseases: A cluster randomized clinical trial in primary care. Patient Educ Couns. 2015 Aug;98(8):977-83. doi: 10.1016/j.pec.2015.03.008. Epub 2015 Mar 18.'}, {'pmid': '24378144', 'type': 'DERIVED', 'citation': 'Perula de Torres LA, Pulido Ortega L, Perula de Torres C, Gonzalez Lama J, Olaya Caro I, Ruiz Moral R; Grupo corporativo Estudio ATEM-AP. [Efficacy of motivational interviewing for reducing medication errors in chronic patients over 65 years with polypharmacy: Results of a cluster randomized trial]. Med Clin (Barc). 2014 Oct 21;143(8):341-8. doi: 10.1016/j.medcli.2013.07.032. Epub 2013 Dec 28. Spanish.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate that an intervention based on the motivational interview directed to patients with polypharmacy to improve the Therapeutic Adherence and to reduce the errors of Medication in major measure that the habitual intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with polypharmacy (5 or more medicines)\n* That detects to them a problem of Therapeutic Adherence\n* That agree to take part in the study\n\nExclusion Criteria:\n\n* Immobilized patients or with an index of Barthel lower than 60 points\n* Incapable to fulfill ABVD\n* Patients with cognitive deterioration\n* Patients with diagnosis of ictus in the last 6 months\n* That has been admitted to hospital 2 or more times in the last year Institutionalized patients'}, 'identificationModule': {'nctId': 'NCT01291966', 'acronym': 'ATEM-AP', 'briefTitle': 'Efficacy of a Intervention to Reduce Medication Errors and Improve Adherence', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital Universitario Reina Sofia de Cordoba'}, 'officialTitle': 'Efficacy of a Intervention to Reduce Medication Errors and Therapeutic Failure in Patients Over 65 Years Polypharmacy', 'orgStudyIdInfo': {'id': 'PI-0101/2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motivational interview', 'interventionNames': ['Behavioral: Motivational interview']}], 'interventions': [{'name': 'Motivational interview', 'type': 'BEHAVIORAL', 'otherNames': ['Counseling', 'Patient-centered method'], 'armGroupLabels': ['Motivational interview']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14011', 'city': 'Córdoba', 'state': 'Córdoba', 'country': 'Spain', 'facility': 'Unidad Docente de Medicina Familiar y Comunitaria', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}], 'overallOfficials': [{'name': 'Luis A Perula, PH D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Andalusian Health Service'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Reina Sofia de Cordoba', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Sociedad Andaluza de Medicina Familiar y Comunitaria', 'class': 'UNKNOWN'}, {'name': 'Sociedad Española de Medicina Familiar y Comunitaria', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Luis A Pérula', 'oldOrganization': 'Andalusian Health Service'}}}}