Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-02-27 @ 10:33 AM
Study NCT ID:
NCT01965392
Status:
COMPLETED
Last Update Posted:
2013-10-18
First Post:
2013-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency of an Educational Program for Informal Caregivers of Hospitalized, Dependent Patients: Cluster Randomised Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-15', 'studyFirstSubmitDate': '2013-10-07', 'studyFirstSubmitQcDate': '2013-10-15', 'lastUpdatePostDateStruct': {'date': '2013-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'life quality', 'timeFrame': 'Data were evaluated with an average one month after discharge, a maximum in September 2009'}], 'secondaryOutcomes': [{'measure': 'Caregiver´s burden', 'timeFrame': 'Data were evaluated with an average one month after discharge, a maximum in September 2009'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Dependence, Dementias']}, 'descriptionModule': {'briefSummary': "The aim was to assess whether nursing interventions based on Health Educational Programs for primary informal caregivers of dependent patients may improve their quality of life, decreasing emotional burden and increasing caregiving knowledge, in order to better meet patients' basic needs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary informal caregivers of dependent patients, admitted in 30 hospital units, with expected hospital stays of at least one week. A dependent patient is understood to require the aid of someone else in order to carry out basic daily activities.\n\nExclusion Criteria:\n\n* caregivers with cognitive deficits that could be an obstacle for adequate verbal understanding, illiteracy, persons taking part in other clinical trials or who had taken part in similar workshops in the previous two years, as well as health professionals.'}, 'identificationModule': {'nctId': 'NCT01965392', 'briefTitle': 'Efficiency of an Educational Program for Informal Caregivers of Hospitalized, Dependent Patients: Cluster Randomised Trial', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal'}, 'orgStudyIdInfo': {'id': 'ESCPD-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'healtn education', 'description': 'one group received an educational program', 'interventionNames': ['Other: Health education intervention']}], 'interventions': [{'name': 'Health education intervention', 'type': 'OTHER', 'description': "'Health education intervention'", 'armGroupLabels': ['healtn education']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}