Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2026-01-02 @ 7:25 PM
Study NCT ID:
NCT02976961
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2016-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Personalized and Interactive Web-based Health Care Innovation to Advance the Quality of Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079102', 'term': 'Empowerment'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 478}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2016-11-22', 'studyFirstSubmitQcDate': '2016-11-29', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device acceptance', 'timeFrame': '12 months', 'description': 'Measured with the Florida Patient Acceptance Survey (FPAS)'}], 'secondaryOutcomes': [{'measure': 'Health status (generic)', 'timeFrame': '12 and 24 months', 'description': 'Measured with the Short Form Health Survey 12 items (SF-12)'}, {'measure': 'Patient empowerment (ICD-EMPOWER)', 'timeFrame': '12 and 24 months', 'description': 'Purpose-designed and disease-specific 14-item measure that measures patient empowerment'}, {'measure': 'ICD patient concerns (ICDC)', 'timeFrame': '12 and 24 months', 'description': "8-item ICD Patients' Concern questionnaire that taps into fear of shock as reported by the patient"}, {'measure': 'Symptoms of anxiety', 'timeFrame': '12 and 24 months', 'description': 'Generalized Anxiety Disorder scale (GAD-7)'}, {'measure': 'Symptoms of depression', 'timeFrame': '12 and 24 months', 'description': 'Patient Health Questionnaire (PHQ-9)'}, {'measure': 'Health status (heart failure specific)', 'timeFrame': '12 and 24 months', 'description': 'Kansas City Cardiomyopathy Questionnaire (KCCQ-12)'}, {'measure': 'Return to work', 'timeFrame': '12 and 24 months', 'description': 'Purpose-designed questions'}, {'measure': 'Time to first ICD therapy', 'timeFrame': '12 and 24 months', 'description': 'Defined as ATP, cardioversion or shock'}, {'measure': 'Time to first hospitalization due to a cardiac cause', 'timeFrame': '12 and 24 months', 'description': 'Hospitalization due to a cardiac cause'}, {'measure': 'Time to mortality', 'timeFrame': '12 and 24 months', 'description': 'Mortality'}, {'measure': 'Cost-effectiveness', 'timeFrame': '12 and 24 months', 'description': "Incremental cost gained per quality adjusted life year (QALY) and burden on health care professionals (physicians and nurses)). This will be measured with the EQ-5D-5L or captured from the patient's electronic health record (EHR; e.g. number of phone calls, emails, and consultations with patients), and purpose-designed questions."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Information', 'Empowerment'], 'conditions': ['Implantable Defibrillator User', 'Distress']}, 'referencesModule': {'references': [{'pmid': '29969990', 'type': 'DERIVED', 'citation': 'Pedersen SS, Skovbakke SJ, Wiil UK, Schmidt T, dePont Christensen R, Brandt CJ, Sorensen J, Vinther M, Larroude CE, Melchior TM, Riahi S, Smolderen KGE, Spertus JA, Johansen JB, Nielsen JC. Effectiveness of a comprehensive interactive eHealth intervention on patient-reported and clinical outcomes in patients with an implantable cardioverter defibrillator [ACQUIRE-ICD trial]: study protocol of a national Danish randomised controlled trial. BMC Cardiovasc Disord. 2018 Jul 3;18(1):136. doi: 10.1186/s12872-018-0872-7.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the clinical efficacy and cost-effectiveness of the ACQUIRE-ICD care innovation as add-on to usual care as compared to usual care alone in patients with an implantable cardioverter defibrillator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a first-time ICD or CRT-D\n* ≥18 years of age\n\nExclusion Criteria:\n\n* Subcutaneous ICD\n* Upgrade from a pacemaker to ICD or CRT\n* History of psychiatric illness other than affective/anxiety disorders\n* Cognitive impairments (e.g. dementia)\n* Left ventricular assist device (LVAD) or upcoming LVAD implant\n* Under evaluation or on the waiting list for heart transplantation\n* No e-mail address\n* Inability to manage or cope with computer technology\n* Insufficient knowledge of the Danish language\n* Participation in other randomized controlled trials unless of a technical nature\n* Irresponsible to ask patient to participate according to GCP'}, 'identificationModule': {'nctId': 'NCT02976961', 'acronym': 'ACQUIRE-ICD', 'briefTitle': 'A Personalized and Interactive Web-based Health Care Innovation to Advance the Quality of Care', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'A Personalized and Interactive Web-based Health Care Innovation to AdvanCe the QualIty of Life and CaRE of Patients with an Implantable Cardioverter Defibrillator', 'orgStudyIdInfo': {'id': '31779'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Implantable cardioverter defibrillator implant + usual care + supportive care given via an e-health platform. The supportive care consists of information, dialogue with a nurse or psychologist, CBT-based psychological intervention online, quizzes to increase knowledge', 'interventionNames': ['Other: Supportive care']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Implantable cardioverter defibrillator implant + usual care'}], 'interventions': [{'name': 'Supportive care', 'type': 'OTHER', 'description': 'Information, guidance, supportive care, and psychological intervention', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Gentofte Municipality', 'state': 'Hellerup', 'country': 'Denmark', 'facility': 'Gentofte Hospital', 'geoPoint': {'lat': 55.74903, 'lon': 12.54601}}, {'zip': '9100', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '4000', 'city': 'Roskilde', 'country': 'Denmark', 'facility': 'Zealand University Hospital - Roskilde', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}], 'overallOfficials': [{'name': 'Susanne S Pedersen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Susanne Schmidt Pedersen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Odense University Hospital', 'class': 'OTHER'}, {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, {'name': 'Zealand University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Susanne Schmidt Pedersen', 'investigatorAffiliation': 'University of Southern Denmark'}}}}