{
  "FullStudy":{
    "Rank":218138,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512238",
          "OrgStudyIdInfo":{
            "OrgStudyId":"CO01"
          },
          "Organization":{
            "OrgFullName":"University of Aarhus",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Improvement of Intentional and Unintentional Non-adherence in the Elderly",
          "OfficialTitle":"Improvement of Intentional and Unintentional Non-adherence in the Elderly. Importance of Pharmaceutical Care, Generic Substitution, Non-prescription Drugs, Herbal Medicine and Dietary Supplements"
        },
        "StatusModule":{
          "StatusVerifiedDate":"December 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2010"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"January 2011",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"November 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 4, 2012",
          "StudyFirstSubmitQCDate":"January 13, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 30, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"October 1, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University of Aarhus",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose is to study if different factors influence medicine adherence in elderly people. In this study number of generic substitution and use of non-prescription drugs, herbal medicine and dietary supplement is in focus.",
          "DetailedDescription":"The purpose of this study is to describe in the elderly:\n\nAssociation between medicine adherence and number of generic substitution\nAssociation between medicine adherence and use of non-prescription drugs, herbal medicine and dietary supplements and interaction between 'prescription drugs' and 'non-prescription drugs, herbal medicine and dietary supplements'\nIntentional and unintentional non-adherence\n\nSome of the data in the present study were originally collected as part of a major research project 'Methods for Improving Compliance with Medicine Intake' (MICMI). The study sample of 945 persons was randomly selected into three groups: two intervention groups and one control group. Interventions were pharmaceutical care and an electronic reminder system. All groups were followed for one year.\n\nData in the present study is from the pharmaceutical care group and the control group, and is descriptive."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Medication Adherence"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Medicine adherence",
              "Drug substitution",
              "Herb-drug interaction",
              "Herbal medicine",
              "Dietary supplements",
              "Over-the-counter products",
              "On-line prescription records",
              "Personal electronic medicine profile",
              "Intentional non-adherence",
              "Unintentional non-adherence"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Retrospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"630",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Pharmaceutical care",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Pharmaceutical care"
                  ]
                }
              },{
                "ArmGroupLabel":"Control"
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"Pharmaceutical care",
                "InterventionDescription":"Information about medicine, sideeffect, adherence",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Pharmaceutical care"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Pharmaceutical Services"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Medicine adherence",
                "PrimaryOutcomeTimeFrame":"One year"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Number of generic substitution",
                "SecondaryOutcomeTimeFrame":"One year"
              },{
                "SecondaryOutcomeMeasure":"Use of non-prescription drugs, herbal medicine and dietary supplements and frequency of interaction between 'prescription drugs' and 'non-prescription drugs, herbal medicine and dietary supplements'",
                "SecondaryOutcomeTimeFrame":"Actually day"
              },{
                "SecondaryOutcomeMeasure":"Intentional and unintentional non-adherence association with generic substitution and use of non-prescription drugs, herbal medicine and dietary supplements",
                "SecondaryOutcomeTimeFrame":"One year"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAged 65 years or older\nLiving in their own homes\nWithout assistance to medicine administration\nLiving in the Municipality of Aarhus, Denmark\nLong-term treatment with > 4 prescription drugs\n\nExclusion Criteria:",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Older Adult"
            ]
          },
          "StudyPopulation":"Persons aged 65 years or older, living in their own homes without assistance to medicine administration in the Municipality of Aarhus, Denmark and who were in long-term treatment with > 4 prescription drugs at the beginning of the project",
          "SamplingMethod":"Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Else Marie S Damsgaard, Professor",
                "OverallOfficialAffiliation":"Aarhus University Hospital",
                "OverallOfficialRole":"Study Chair"
              },{
                "OverallOfficialName":"Ishay Barat, Ph.D.",
                "OverallOfficialAffiliation":"Horsens Hospital",
                "OverallOfficialRole":"Study Chair"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}