{
  "FullStudy":{
    "Rank":217946,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514773",
          "OrgStudyIdInfo":{
            "OrgStudyId":"HUM00050147"
          },
          "Organization":{
            "OrgFullName":"University of Michigan",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Patient and Physician Survey Determinants of Appropriate ICD Utilization",
          "OfficialTitle":"Patient and Physician Knowledge and Attitudes Toward Defibrillator Therapy Survey Study"
        },
        "StatusModule":{
          "StatusVerifiedDate":"March 2017",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"August 2011",
            "StartDateType":"Actual"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"August 30, 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"August 30, 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 17, 2012",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 15, 2017",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 17, 2017",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor-Investigator",
            "ResponsiblePartyInvestigatorFullName":"Todd M Koelling, MD",
            "ResponsiblePartyInvestigatorTitle":"Associate Professor, Director Heart Failure Program",
            "ResponsiblePartyInvestigatorAffiliation":"University of Michigan"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Todd M Koelling, MD",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Medtronic",
                "CollaboratorClass":"INDUSTRY"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"To better understand the reasons for underutilization of defibrillator therapy in selected populations, the investigators propose a study to assess heart failure patient knowledge and attitudes toward device therapy. By carefully studying populations of patients with systolic heart failure, the investigators aim to identify the underlying reasons for implantable cardioverter defibrillators (ICD) non-utilization in patients with symptomatic systolic heart failure.",
          "DetailedDescription":"Several multi-center randomized trials have demonstrated the benefit of implantable cardioverter defibrillators (ICDs) for the primary prevention of sudden cardiac death among patients with ischemic and nonischemic cardiomyopathy. Guideline documents for the treatment of heart failure have recommended defibrillator placement for patients with symptomatic heart failure and left ventricular ejection fraction (LVEF) ≤ 35%. Despite these recommendations, observational studies have documented low ICD utilization among patients with heart failure. Recent studies have demonstrated patient specific characteristics that are associated with low ICD utilization (advanced age, female gender, black race, heart failure etiology, uninsured patients and patients cared for by general practitioners). Whether patient knowledge or attitudes regarding defibrillator therapy influence the rate of defibrillator placement is unknown. By carefully surveying populations of patients with systolic heart failure, we aim to further the understanding of the patient factors that determine why an ICD may or may not be used in the appropriate clinical setting. Additionally, 150 physicians will be enrolled into the study for the purpose of measuring attitudes and beliefs regarding defibrillator treatment for the physicians providing care to the patients in the study."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Heart Failure, Systolic"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "left ventricular systolic dysfunction",
              "implantable cardioverter defibrillator",
              "systolic heart failure",
              "congestive heart failure",
              "Ischemic cardiomyopathy",
              "Nonischemic cardiomyopathy",
              "ICD",
              "ICD utilization",
              "ICD implantation",
              "defibrillator",
              "defibrillator therapy",
              "sudden cardiac death"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case-Control"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Other"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"452",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"ICD placement",
                "ArmGroupDescription":"Those subjects who have an ICD."
              },{
                "ArmGroupLabel":"No ICD placement",
                "ArmGroupDescription":"Those subjects who have not had an ICD placed."
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Patient Determinants of Appropriate ICD Utilization",
                "PrimaryOutcomeDescription":"Specifically, we will assess patients for knowledge deficits regarding the clinical effects of ICD therapy. We will assess patients for their opinions regarding their risk of death, and whether they are willing to trade time to avoid discomfort of their illness or ICD shocks. We will ask patients about their thoughts about financial concerns regarding ICD therapy and their trust in technology, their physician and the medical system. We will also ask patients about their opinions regarding cosmetic issues created by ICD placement.",
                "PrimaryOutcomeTimeFrame":"1 year"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Physician Determinants of Appropriate ICD Utilization",
                "SecondaryOutcomeDescription":"Measure physician knowledge and attitudes regarding defibrillator therapy for the physicians providing care to the patients in the study and assess the relationship between these measures and appropriate defibrillator utilization. We will assess physicians understanding of ICD clinical effects, costs, and risks of complications.",
                "SecondaryOutcomeTimeFrame":"1 year"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAge ≥ 18 years old\nLeft ventricular ejection fraction ≤ 35%\nPrevious diagnosis of heart failure with current NYHA Class II-III symptoms\nEstablished UMHS patient with at least two outpatient visits in the past two years to either Primary Care or Cardiology, OR, at least one inpatient admission in the past two years along with at least one outpatient visit within the past 13 months to Primary Care or Cardiology\n\nExclusion Criteria:\n\nPatients having undergone heart transplantation\nPatients having undergone placement of a left ventricular assist device\nPatients with congenital heart disease",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"University of Michigan Health System Ambulatory Heart Failure Registry",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Todd M Koelling, MD",
                "OverallOfficialAffiliation":"University of Michigan",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"University of Michigan Health System",
                "LocationCity":"Ann Arbor",
                "LocationState":"Michigan",
                "LocationZip":"48109",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000006333",
                "ConditionMeshTerm":"Heart Failure"
              },{
                "ConditionMeshId":"D000054143",
                "ConditionMeshTerm":"Heart Failure, Systolic"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000006331",
                "ConditionAncestorTerm":"Heart Diseases"
              },{
                "ConditionAncestorId":"D000002318",
                "ConditionAncestorTerm":"Cardiovascular Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M9126",
                "ConditionBrowseLeafName":"Ischemia",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10737",
                "ConditionBrowseLeafName":"Cardiomyopathies",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M17701",
                "ConditionBrowseLeafName":"Death, Sudden, Cardiac",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8004",
                "ConditionBrowseLeafName":"Heart Failure",
                "ConditionBrowseLeafAsFound":"Heart Failure",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M26166",
                "ConditionBrowseLeafName":"Heart Failure, Systolic",
                "ConditionBrowseLeafAsFound":"Heart Failure, Systolic",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M5428",
                "ConditionBrowseLeafName":"Death",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8002",
                "ConditionBrowseLeafName":"Heart Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              }
            ]
          }
        }
      }
    }
  }
}