{
  "FullStudy":{
    "Rank":217754,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517269",
          "OrgStudyIdInfo":{
            "OrgStudyId":"13643"
          },
          "Organization":{
            "OrgFullName":"University of Massachusetts, Worcester",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"PETS-D (Parent Education Thru Simulation-Diabetes)",
          "OfficialTitle":"PETS-D (Parent Education Thru Simulation-Diabetes)"
        },
        "StatusModule":{
          "StatusVerifiedDate":"March 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"April 2010"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 2015",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"March 2015",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 13, 2012",
          "StudyFirstSubmitQCDate":"January 24, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 6, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 9, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Susan Sullivan-Bolyai",
            "ResponsiblePartyInvestigatorTitle":"Study Principal Investigator",
            "ResponsiblePartyInvestigatorAffiliation":"University of Massachusetts, Worcester"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University of Massachusetts, Worcester",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"Hypothesis: Parents who receive Parent Education Thru Simulation-Diabetes (PETS-D) will have significantly higher diabetes knowledge (cognitive visual schemata), better technical and problem-solving competence and confidence, and lower fear and stress/anxiety levels; and provide better diabetes management at 14 weeks compared to those parents receiving standard diabetes education."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Type 1 Diabetes"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Parent education"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Supportive Care",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"191",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Education with simulator",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Parent randomized to this group will be taught diabetes management with vignette and simulator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Parent education with human patient simulator"
                  ]
                }
              },{
                "ArmGroupLabel":"Control arm: standard diabetes education",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Parents will receive standard diabetes education with a diabetes educator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Standard care"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"Parent education with human patient simulator",
                "InterventionDescription":"After child is newly diagnosed with Type 1 diabetes, parents will receive 3 teaching sessions over 12 weeks, after baseline data collected, at 1 month, and at 3 months, covering hypoglycemia, hyperglycemia and pattern management using teaching vignettes and practice with human patient simulator",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Education with simulator"
                  ]
                }
              },{
                "InterventionType":"Behavioral",
                "InterventionName":"Standard care",
                "InterventionDescription":"After child is newly diagnosed with Type 1 diabetes, parents will receive 3 teaching sessions over 12 weeks, after baseline data collected, at 1 month, and at 3 months, covering hypoglycemia, hyperglycemia and pattern management without the use of a simulator",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Control arm: standard diabetes education"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Change in baseline of Diabetes Knowledge",
                "PrimaryOutcomeDescription":"Diabetes Awareness and Reasoning Test-Parents (DART-P)is a 47-item multiple-choice questionnaire. The subscales include general, insulin, hyper-hypglycemia, and problem-solving. Parent education was a significant predictor of total scores.",
                "PrimaryOutcomeTimeFrame":"Baseline and 14 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Change in Baseline of Problem solving",
                "SecondaryOutcomeDescription":"Wysocki's Modified Problem-solving measure18 (PSM) is a 5 item questionnaire that focuses on how to proactively prevent and treat hypoglycemia. Dr. Wysocki sent us one of his vignettes developed from the structured interview measure. Based on the examples of probes that are part of the interview, we constructed a 5-question multiple choice instrument to measure parental problem-solving abilities and knowledge synthesis. We will report the reliability and validity of this measure with data from the proposed study.",
                "SecondaryOutcomeTimeFrame":"Baseline and 14 weeks"
              },{
                "SecondaryOutcomeMeasure":"Change in Baseline of Diabetes management",
                "SecondaryOutcomeDescription":"Diabetes Management Outcomes is a 5 question likert scale based on ADA2 management recommendations.",
                "SecondaryOutcomeTimeFrame":"Baseline and 14 weeks"
              },{
                "SecondaryOutcomeMeasure":"Change in Baseline of Diabetes self efficacy",
                "SecondaryOutcomeDescription":"The Self-Efficacy Diabetes-Pediatrics (SED-P) will be used to measure parent confidence in specific task and skill associated diabetes care, i.e. how confident they feel to perform day-to-day diabetes management.",
                "SecondaryOutcomeTimeFrame":"Baseline and 14 weeks"
              },{
                "SecondaryOutcomeMeasure":"Change in Baseline of Fear of hypoglycemia",
                "SecondaryOutcomeDescription":"The Hypoglycemia Fear Survey-Parents (HFS-P) total score will be used to measure parental fears and avoidance behaviors associated with hypoglycemia in their children.There are 2 subscales that measure parental concerns of their child experiencing an episode of hypoglycemia and behaviors they use to prevent these episodes from occurring",
                "SecondaryOutcomeTimeFrame":"Baseline and 14 weeks"
              },{
                "SecondaryOutcomeMeasure":"Change in Baseline of Parent anxiety",
                "SecondaryOutcomeDescription":"State-Trait Anxiety (STAI) is a well established 40-item instrument (Likert scale, with 1 being not at all, to 4 being almost always) used to measure situational (state, how one feels at this moment) and stable (trait, how one feels in general) tendencies toward anxiety. Higher scores signify more anxiety",
                "SecondaryOutcomeTimeFrame":"Baseline and 14 weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nparents 18 years and older who have a child newly diagnosed with type 1 diabetes mellitus (T1DM) from 5 years old to under 13 years of age\n\nExclusion Criteria:\n\nexclude children with developmental delays (such as Down Syndrome, Autism) or steroid induced diabetes (cancer treatment related or cystic fibrosis)\nexclude parents who require insulin treatment -or- those that have another child with TIDM",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"University of Massachusetts, Worcester",
                "LocationCity":"Worcester",
                "LocationState":"Massachusetts",
                "LocationZip":"01655",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"26246593",
                "ReferenceType":"derived",
                "ReferenceCitation":"Sullivan-Bolyai S, Crawford S, Bova C, Lee M, Quintos JB, Johnson K, Cullen K, Hamm T, Bisordi J, Ramchandani N, Fletcher J, Quinn D, Jaffarian C, Lipman T, Melkus G. PETS-D: Impact on Diabetes Management Outcomes. Diabetes Educ. 2015 Oct;41(5):537-49. doi: 10.1177/0145721715598383. Epub 2015 Aug 5."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000003920",
                "ConditionMeshTerm":"Diabetes Mellitus"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000044882",
                "ConditionAncestorTerm":"Glucose Metabolism Disorders"
              },{
                "ConditionAncestorId":"D000008659",
                "ConditionAncestorTerm":"Metabolic Diseases"
              },{
                "ConditionAncestorId":"D000004700",
                "ConditionAncestorTerm":"Endocrine System Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M5698",
                "ConditionBrowseLeafName":"Diabetes Mellitus",
                "ConditionBrowseLeafAsFound":"Diabetes",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M5700",
                "ConditionBrowseLeafName":"Diabetes Mellitus, Type 1",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10222",
                "ConditionBrowseLeafName":"Metabolic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M23990",
                "ConditionBrowseLeafName":"Glucose Metabolism Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M6445",
                "ConditionBrowseLeafName":"Endocrine System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC19",
                "ConditionBrowseBranchName":"Gland and Hormone Related Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC20",
                "ConditionBrowseBranchName":"Immune System Diseases"
              }
            ]
          }
        }
      }
    }
  }
}