Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-29 @ 7:01 PM
Study NCT ID:
NCT00126295
Status:
COMPLETED
Last Update Posted:
2005-08-19
First Post:
2005-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of an Individualised Written Education Package for Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'ECT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-08', 'completionDateStruct': {'date': '2005-05'}, 'lastUpdateSubmitDate': '2005-08-18', 'studyFirstSubmitDate': '2005-08-02', 'studyFirstSubmitQcDate': '2005-08-02', 'lastUpdatePostDateStruct': {'date': '2005-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'knowledge about stroke'}, {'measure': 'self-efficacy'}, {'measure': 'anxiety'}, {'measure': 'depression'}, {'measure': 'perceived health status (patients only)'}, {'measure': 'satisfaction with the content and presentation of the information received'}, {'measure': 'desire for additional information'}]}, 'conditionsModule': {'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '34813082', 'type': 'DERIVED', 'citation': 'Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of the randomised controlled trial was to evaluate the effectiveness of a tailored written education package ("What you need to know about stroke") on the outcomes of:\n\n* Knowledge about stroke, self-efficacy, anxiety, depression, perceived health status, satisfaction with the content and presentation of the information received, and desire for additional information for patients following stroke and\n* Knowledge about stroke, self-efficacy, anxiety, depression, satisfaction with the content and presentation of the information received, and desire for additional information for their carers.\n\nA secondary aim was to evaluate the effect of written information on the outcomes of knowledge about stroke, self-efficacy, anxiety, depression, and perceived health status of patients following stroke and on knowledge about stroke, self-efficacy, anxiety, and depression of their carers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Had a stroke or transient ischemic attack (TIA) or was the informal carer of a person who had a stroke or TIA;\n* Had a reported English-proficiency level, corrected hearing and vision, and communication status adequate to participate in an interview and complete assessment tasks;\n* Did not have reported or observable dementia;\n* Lived within 50km of the hospital, for ease of follow-up; and\n* Was medically stable.'}, 'identificationModule': {'nctId': 'NCT00126295', 'briefTitle': 'Evaluation of an Individualised Written Education Package for Stroke Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medical Benefits Fund of Australia'}, 'officialTitle': 'Evaluation of a Computer-Generated Individualised Written Education Package for Patients Following Stroke and Their Carers', 'orgStudyIdInfo': {'id': '2002000023'}}, 'armsInterventionsModule': {'interventions': [{'name': "'What you need to know about stroke' education package", 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4029', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Royal Brisbane Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}], 'overallOfficials': [{'name': 'Tammy C Hoffmann', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Queensland'}, {'name': 'Kryss McKenna', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Queensland'}, {'name': 'Linda Worrall', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Queensland'}, {'name': 'Stephen Read', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Brisbane Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Benefits Fund of Australia', 'class': 'INDUSTRY'}}}}