Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-31 @ 10:23 AM
Study NCT ID:
NCT00845234
Status:
COMPLETED
Last Update Posted:
2013-02-26
First Post:
2009-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishing a Standard for Peri-operative Implantable Cardioverter Defibrillator (ICD) Patient Education
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-25', 'studyFirstSubmitDate': '2009-02-17', 'studyFirstSubmitQcDate': '2009-02-17', 'lastUpdatePostDateStruct': {'date': '2013-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score on measure assessing construct of quality of life', 'timeFrame': 'Up to 8 months after enrollment', 'description': 'Quality of life will be obtained via participants scores from the Medical Outcomes Survey Short Form-12 (SF-12) measure of quality of life.'}], 'secondaryOutcomes': [{'measure': 'Score on measure assessing depression', 'timeFrame': 'Up to 8 months after enrollment', 'description': "Depression will be assessed via participant's self-reported scores on the depression subscale of the Hospital Anxiety and Depression Scale (HADS)."}, {'measure': 'score on measure assessing construct of patient acceptance of device', 'timeFrame': 'up to 8 months after enrollment', 'description': "The Florida Patient Acceptance Scale measures patient's self-reported acceptance of the implantable cardioverter defibrillator."}, {'measure': 'score on measure assessing anxiety', 'timeFrame': 'Up to 8 months after enrollment', 'description': "The Hospital Anxiety and Depression Scale is comprised of two subscales- anxiety and depression. It is a self-report measure that generates a score on the patient's current level of anxiety."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['behavioral intervention', 'implantable cardioverter defibrillator', 'psychosocial education', 'anxiety', 'depression'], 'conditions': ['Arrhythmia']}, 'descriptionModule': {'briefSummary': 'An implantable cardioverter defibrillator (ICD) administers a shock to terminate potentially life-threatening cardiac arrhythmias. The device saves lives, but presents psychological challenges for patients. At present, there is a paucity of brief interventions for ICD patients designed for administration in a clinic setting that considers issues of cost, time, and available resources. The present study examined the impact of a brief cognitive behavioral (CBT) educational intervention on primary endpoints of patient acceptance and quality of life and secondary endpoints of depression and anxiety. It was hypothesized that the intervention would result in significant improvements primary and secondary endpoints for participants in the intervention group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18+ years old\n* literate\n* newly implanted with an implantable cardioverter defibrillator (ICD)\n\nExclusion Criteria:\n\n* documented neurological sequelae associated with CVA or dementia\n* documented cognitive impairment\n* reported illiteracy\n* previously implanted ICD'}, 'identificationModule': {'nctId': 'NCT00845234', 'briefTitle': 'Establishing a Standard for Peri-operative Implantable Cardioverter Defibrillator (ICD) Patient Education', 'organization': {'class': 'OTHER', 'fullName': 'East Carolina University'}, 'officialTitle': 'Establishing a Standard for Peri-operative ICD Patient Education: A Demonstration Project', 'orgStudyIdInfo': {'id': '00293-2008-0356-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care Group', 'description': 'Received the current standard of care as operationally defined by the investigators- Q\\&A session + Video'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Intervention group- Patients will receive the brief educational CBT intervention + video and Q\\&A session', 'interventionNames': ['Behavioral: Intervention']}], 'interventions': [{'name': 'Intervention', 'type': 'BEHAVIORAL', 'description': 'Intervention consisted of a brief, educational CBT intervention and included the following domain areas: ICD knowledge and post-discharge care, understanding shock, stress management, family and relationships, device recall, and survivorship. The intervention was provided at baseline (0 weeks). Intervention was led by investigator and lasted 15 minutes in duration.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Aurora Denver Cardiology Associates', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80124', 'city': 'Lone Tree', 'state': 'Colorado', 'country': 'United States', 'facility': 'Aurora Denver Cardiology Associates', 'geoPoint': {'lat': 39.55171, 'lon': -104.8863}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'East Carolina Heart Institute', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}], 'overallOfficials': [{'name': 'Samuel F Sears, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'East Carolina University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'East Carolina University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aurora Denver Cardiology Associates', 'class': 'UNKNOWN'}, {'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Samuel F. Sears', 'investigatorAffiliation': 'East Carolina University'}}}}