Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2025-12-25 @ 8:45 PM
Study NCT ID:
NCT01331369
Status:
COMPLETED
Last Update Posted:
2017-04-11
First Post:
2011-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intensification of Care to Improve Adherence to Anti-hypertensives
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': 'D003191', 'term': 'Comprehensive Health Care'}], 'ancestors': [{'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 243}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-08', 'studyFirstSubmitDate': '2011-03-29', 'studyFirstSubmitQcDate': '2011-04-07', 'lastUpdatePostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the proportion of people adherent to treatment - MMAS-8', 'timeFrame': 'at basal and 3, 6, 9 and 12 months', 'description': 'It will be measure by "Moriski Medication Adherence Scale 8 item", translated and validated in Brazil. MMAS scores were trichotomized previously into the following 3 levels of adherence: high adherence (score, 8), medium adherence (score, 6 to \\<8), and low adherence (score, \\<6).'}], 'secondaryOutcomes': [{'measure': 'Change in the proportion of people adherent to treatment - QAM-Q', 'timeFrame': 'at basal and 3, 6, 9 and 12 months', 'description': 'It will be measure by "Questionário de Adesão a Medicamentos -Qualiaids" 3 item, an structured questionnaire developed and validated in Brazil. Non-adherence was accepted if respondent doesn\'t take 80% of his medicines or if he/she presents any errors on the process (time, jumps..)'}, {'measure': 'Means difference and/or risk ratio between and within groups of clinical outcomes', 'timeFrame': 'at basal and 3, 6, 9 and 12 months', 'description': 'It will be evaluated mean blood pressure, proportion of complications, hospitalization and death in each group.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adherence', 'compliance', 'persistence', 'drop out', 'abandon'], 'conditions': ['Medication Adherence']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://dgp.cnpq.br/dgp/espelhogrupo/4971570719283133', 'label': 'Research Group of Pharmacoepidemiology'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the effectiveness of a social-psychological intervention to improve anti-hypertensives adherence in primary care. Its is a pragmatic clinical trial.', 'detailedDescription': 'We will study two groups of 198 people with hypertension treated in ten health care units. One group will receive usual care dispensed in units (control). The other group (intervention) will be offered six individual assistance with health care worker physician or nurse) during the period of 9 months with a minimum interval of 30 days, plus 9 monthly visits structured by community health agents. Adherence will be measured in both groups at baseline and months 3, 6, 9 and 12, through validated questionnaire and pill count. Also evaluated clinical outcome measures (blood pressure, hospitalizations and deaths). The analysis will be done by intention to treat comparing adherence measures and clinical outcome between groups (Student t test and chi-square test) and within groups over time (paired t test and McNemar). It will be accepted p value \\<0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* persons with hypertension aged 18 years and older\n\nExclusion Criteria:\n\n* those with physical or mental impaired that cannot go to health care units or cannot answer a questionnaire\n* pregnants'}, 'identificationModule': {'nctId': 'NCT01331369', 'acronym': 'HyperCare', 'briefTitle': 'Intensification of Care to Improve Adherence to Anti-hypertensives', 'organization': {'class': 'OTHER', 'fullName': 'Universidade de Blumenau'}, 'officialTitle': 'Intensification of Care to Improve Adherence to Anti-hypertensives in Primary Care: a Pragmatic Clinical Trial.', 'orgStudyIdInfo': {'id': 'FURB 2010/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Usual care. It means routine medical care that include free demand consultation and free medicines.', 'interventionNames': ['Other: Usual Care']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Intensification of care. Besides routine medical care that include free demand consultation and free medicines, subjects were invited to have 6 structured medical encounters based on a social-psychological approach. Doctors must follow a protocol to conduct the encounter that have around 30 minutes each.', 'interventionNames': ['Behavioral: Intensification of Care']}], 'interventions': [{'name': 'Intensification of Care', 'type': 'BEHAVIORAL', 'otherNames': ['Comprehensive Care'], 'description': 'Usual provided care plus social-psychological intervention: 6 consultation with doctors and 9 with community health workers, both oriented by protocol.', 'armGroupLabels': ['Intervention']}, {'name': 'Usual Care', 'type': 'OTHER', 'otherNames': ['Usual'], 'description': 'Usual care provided (medical and/or nurse consultation and medicines)', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Blumenau', 'state': 'Santa Catarina', 'country': 'Brazil', 'facility': 'Family Health Units - Unique Health System', 'geoPoint': {'lat': -26.91944, 'lon': -49.06611}}], 'overallOfficials': [{'name': 'Ernani S Helena, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Regional University of Blumenau'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade de Blumenau', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundacao de Apoio a Pesquisa de Santa Catarina', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ernani Tiaraju de Santa Helena', 'investigatorAffiliation': 'Universidade de Blumenau'}}}}