{
  "FullStudy":{
    "Rank":217710,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517841",
          "OrgStudyIdInfo":{
            "OrgStudyId":"IRB11-00542"
          },
          "Organization":{
            "OrgFullName":"MetroHealth Medical Center",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Barriers to Peritoneal Dialysis Selection",
          "OfficialTitle":"Barriers to Selection and Initiation of Peritoneal Dialysis in the United States"
        },
        "StatusModule":{
          "StatusVerifiedDate":"June 2018",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"August 2012",
            "StartDateType":"Actual"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 20, 2012",
          "StudyFirstSubmitQCDate":"January 24, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"June 12, 2018",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"June 14, 2018",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Ash Sehgal",
            "ResponsiblePartyInvestigatorTitle":"Professor",
            "ResponsiblePartyInvestigatorAffiliation":"MetroHealth Medical Center"
          },
          "LeadSponsor":{
            "LeadSponsorName":"MetroHealth Medical Center",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to understand what prevents chronic kidney disease patients from making a timely decision about dialysis modality options. This understanding will allow us to develop and implement interventions to assist patients in this turning point so that they can make the right decision for them in a timely enough manner so that each patient can start dialysis in the safest and best way for them. 200 later stage chronic kidney disease patients (20% or less of kidney function remaining) will be asked to participate in the study with the goal of having 150 patients participate in the study.\n\nHypotheses:\n\n50 % of patients will have made a modality decision when interviewed and patients in the action stage of behavior will be more likely to make a modality selection than patients in earlier stages of behavior change. Barriers to modality selection will act at several levels including patient, provider and health system level and will vary by behavioral stage of change\n10-15% of patients might choose home dialysis. Knowledge, self efficacy in terms of CKD, education, and income will likely be barriers to home dialysis choice."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Chronic Kidney Disease"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "peritoneal dialysis",
              "modality choice",
              "kidney disease"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"55",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Chronic kidney disease",
                "ArmGroupDescription":"Patients with chronic kidney disease (20% or less kidney function remaining. Patients with end stage renal disease who are currently receiving dialysis."
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Barriers to making a dialysis modality decision",
                "PrimaryOutcomeDescription":"Determine the proportion of patients that made a dialysis modality decision and determine the barriers to being able to make a decision. Determine the proportion of patients choosing home dialysis and barriers associated with choice of home dialysis therapy.",
                "PrimaryOutcomeTimeFrame":"1 year"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAll patients of age greater than or equal to 18 years at MHMC who are late stage CKD\n\nExclusion Criteria:\n\nPatients who have acute renal failure and then recover renal function to levels of eGFR (estimated glomerular filtration rate) 20 mL/min/1.73m2 and in whom the nephrologist feels will not progress to ESRD in 2 years\nPatients who are not candidates for peritoneal dialysis\nPregnant women",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"The study population will consist of patients with late stage CKD and ESRD patients who are cared for by nephrologists at MetroHealth Medical Center.",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Suma Prakash, MD",
                "OverallOfficialAffiliation":"MetroHealth Medical Center",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"MetroHealth Medical Center- Center for Reducing Health Disparities",
                "LocationCity":"Cleveland",
                "LocationState":"Ohio",
                "LocationZip":"44109",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000007674",
                "ConditionMeshTerm":"Kidney Diseases"
              },{
                "ConditionMeshId":"D000051436",
                "ConditionMeshTerm":"Renal Insufficiency, Chronic"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000014570",
                "ConditionAncestorTerm":"Urologic Diseases"
              },{
                "ConditionAncestorId":"D000051437",
                "ConditionAncestorTerm":"Renal Insufficiency"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M9281",
                "ConditionBrowseLeafName":"Kidney Diseases",
                "ConditionBrowseLeafAsFound":"Kidney Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M25304",
                "ConditionBrowseLeafName":"Renal Insufficiency, Chronic",
                "ConditionBrowseLeafAsFound":"Chronic Kidney Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M25305",
                "ConditionBrowseLeafName":"Renal Insufficiency",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15902",
                "ConditionBrowseLeafName":"Urologic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}