{
  "FullStudy":{
    "Rank":218077,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513031",
          "OrgStudyIdInfo":{
            "OrgStudyId":"DRONE_L_06034"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"11-16223",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"Institutional Review Board"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Creighton University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Determination of Rates and Reasons for Non-Adherence to Anti-Arrhythmic Therapy for Atrial Fibrillation",
          "OfficialTitle":"Pilot Project to Determine Rates and Reasons for Non-Adherence in Patients Receiving Chronic Oral Antiarrhythmic Therapy for Atrial Fibrillation in the State of Nebraska"
        },
        "StatusModule":{
          "StatusVerifiedDate":"June 2012",
          "OverallStatus":"Terminated",
          "WhyStopped":"Low enrollment",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"June 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 16, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"June 28, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"July 2, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Creighton University",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Sanofi",
                "CollaboratorClass":"INDUSTRY"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to determine if follow-up by a pharmacist over the telephone improves adherence and short term clinical outcomes in the patient with atrial fibrillation prescribed an oral anti-arrhythmic medication. This study will also identify the reasons people stop taking their anti-arrhythmic therapy. A pharmacist will provide medication counseling about their anti-arrhythmic therapy, then will follow-up by telephone on a monthly basis to assess adherence over one year."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Atrial Fibrillation",
              "Medication Adherence"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Atrial fibrillation",
              "Anti-arrhythmic medication",
              "Medication adherence"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 4"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Health Services Research",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"9",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Phone follow-up",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"All study participants will be receiving education and monthly telephone follow-up.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Education and telephone follow-up"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"Education and telephone follow-up",
                "InterventionDescription":"Education related to anti-arrhythmic therapy and monthly telephone follow-up to assess adherence to medication.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Phone follow-up"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Adherence to anti-arrhythmic medication",
                "PrimaryOutcomeDescription":"Assessing whether patients stop taking anti-arrhythmic medication without instruction to do so by their physician.",
                "PrimaryOutcomeTimeFrame":"1 year"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPrescribed a new anti-arrhythmic medication for atrial fibrillation",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"19 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Dan Hilleman, PharmD",
                "OverallOfficialAffiliation":"Creighton University",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Bryan LGH",
                "LocationCity":"Lincoln",
                "LocationState":"Nebraska",
                "LocationZip":"68506",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Alegent Health Bergan Mercy Medical Center",
                "LocationCity":"Omaha",
                "LocationState":"Nebraska",
                "LocationZip":"68124",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Creighton University",
                "LocationCity":"Omaha",
                "LocationState":"Nebraska",
                "LocationZip":"68178",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000001281",
                "ConditionMeshTerm":"Atrial Fibrillation"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000001145",
                "ConditionAncestorTerm":"Arrhythmias, Cardiac"
              },{
                "ConditionAncestorId":"D000006331",
                "ConditionAncestorTerm":"Heart Diseases"
              },{
                "ConditionAncestorId":"D000002318",
                "ConditionAncestorTerm":"Cardiovascular Diseases"
              },{
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M3167",
                "ConditionBrowseLeafName":"Atrial Fibrillation",
                "ConditionBrowseLeafAsFound":"Atrial Fibrillation",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M3034",
                "ConditionBrowseLeafName":"Arrhythmias, Cardiac",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8002",
                "ConditionBrowseLeafName":"Heart Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}