{
  "FullStudy":{
    "Rank":218006,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513980",
          "OrgStudyIdInfo":{
            "OrgStudyId":"G. A. 250487-Veneto WP8Cl5"
          },
          "Organization":{
            "OrgFullName":"Regione Veneto",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Life-long Monitoring of COPD in Veneto Region",
          "OfficialTitle":"RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring in COPD"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"May 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"May 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 17, 2012",
          "StudyFirstSubmitQCDate":"January 17, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 13, 2017",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 17, 2017",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Regione Veneto",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"European Commission",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Azienda Unità Locale Socio Sanitaria n.9 Treviso",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Azienda ULSS 12 Veneziana",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Azienda ULSS di Verona e Provincia",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Azienda ULSS 16 Padova",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Azienda Ospedaliera di Padova",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Azienda Ospedaliera Universitaria Integrata Verona",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to evaluate whether the introduction of large-scale telemonitoring of patients with COPD produces benefits in terms of improved health-related quality of life and reduced access to hospital facilities. In addition, the trial evaluates the economic and organisational impact of the new services, and examine their acceptability by patients and health professionals.",
          "DetailedDescription":"The study is designed to evaluate the impact of telemonitoring on the management of COPD compared with outpatient usual care. From a clinical point of view, the trial will allow to investigate how telemonitoring contributes to improve COPD patients health-related quality of life and reduct the access to hospital facilities (re-hospitalizations, bed-days, specialistic and ER visits) and the anxiety about health conditions. A cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. The evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professionals perception towards the service."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Pulmonary Disease, Chronic Obstructive"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Chronic Obstructive Pulmonary Disease",
              "Telemonitoring"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Supportive Care",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"750",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Control group",
                "ArmGroupType":"No Intervention",
                "ArmGroupDescription":"Treatment as usual"
              },{
                "ArmGroupLabel":"Self monitoring for patients with COPD",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Procedure: self-monitoring for patients with severe COPD",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: self-monitoring for patients with severe COPD"
                  ]
                }
              },{
                "ArmGroupLabel":"Nurse monitoring for patients with COPD",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Procedure: nurse-monitoring for patients with severe COPD",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: nurse-monitoring for patients with severe COPD"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"self-monitoring for patients with severe COPD",
                "InterventionDescription":"Patients are equipped with a telemonitoring kit composed by a portable wrist-clinic device for clinical parameters measuring and a gateway device for data transmission.\n\nThe patient can monitor pulse-oxymetry and heart rate with a frequency set by the clinician in the personalised treatment plan. Data are transmitted to a regional eHealth centre where a group of operators keeps these information under control and alert the reference clinician in case of worsening of symptoms. CAT questionnaire is monthly administrated by phone to the patients",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Self monitoring for patients with COPD"
                  ]
                }
              },{
                "InterventionType":"Procedure",
                "InterventionName":"nurse-monitoring for patients with severe COPD",
                "InterventionDescription":"A nurse is in charge of data collection during home visits with a frequency set by the lung specialist depending to the patient clinical conditions. The nurse uses portable biomedical devices to measure pulse-oxymetry, heart rate, spirometry and if scheduled an arterial blood gas test. Data are transmitted to the clinician who checks them on his laptop in the hospital and completes the visit with the medical report.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Nurse monitoring for patients with COPD"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Health-Related quality of life",
                "PrimaryOutcomeDescription":"Health-Related Quality of Life is assessed by the SF-36 questionnaire",
                "PrimaryOutcomeTimeFrame":"12 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Number of bed days for hospitalised patients",
                "SecondaryOutcomeTimeFrame":"12 months"
              },{
                "SecondaryOutcomeMeasure":"Number of specialist visits",
                "SecondaryOutcomeTimeFrame":"12 months"
              },{
                "SecondaryOutcomeMeasure":"Number of visits to emergency department",
                "SecondaryOutcomeTimeFrame":"12 months"
              },{
                "SecondaryOutcomeMeasure":"All cause mortality",
                "SecondaryOutcomeTimeFrame":"12 months"
              },{
                "SecondaryOutcomeMeasure":"Anxiety and depression status",
                "SecondaryOutcomeDescription":"Anxiety and depression status is assessed by Hospital Anxiety and Depression Scale, (HADS).",
                "SecondaryOutcomeTimeFrame":"12 months"
              },{
                "SecondaryOutcomeMeasure":"Number of re-hospitalizations",
                "SecondaryOutcomeTimeFrame":"12 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAge ≥ 18 years.\nCOPD GOLD class 3-4\nLife expectance > 12 months\n\nExclusion Criteria:\n\n• Patient unable to use the equipment provided (alone or assisted).",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Massimo Fusello, MD",
                "OverallOfficialAffiliation":"Local Health authority Veneziana",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Ospedale dell'Angelo - Pulmonology Department",
                "LocationCity":"Mestre",
                "LocationState":"Venezia",
                "LocationZip":"30174",
                "LocationCountry":"Italy"
              },{
                "LocationFacility":"Ospedale di Marzana - Rehabilitative respiratory unit",
                "LocationCity":"Marzana",
                "LocationState":"Verona",
                "LocationZip":"37034",
                "LocationCountry":"Italy"
              },{
                "LocationFacility":"Local Health Autority n.16 Padova - Pulmonology outpatient clinic",
                "LocationCity":"Padova",
                "LocationZip":"35127",
                "LocationCountry":"Italy"
              },{
                "LocationFacility":"Hospital Trust of Padova - Respiratory Physiopathology Department",
                "LocationCity":"Padova",
                "LocationZip":"35128",
                "LocationCountry":"Italy"
              },{
                "LocationFacility":"Ospedale Ca'Foncello - Pulmonology Department",
                "LocationCity":"Treviso",
                "LocationZip":"31100",
                "LocationCountry":"Italy"
              },{
                "LocationFacility":"Hospital Trust of Verona - Pneumonology Department",
                "LocationCity":"Verona",
                "LocationZip":"37124",
                "LocationCountry":"Italy"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"27876029",
                "ReferenceType":"derived",
                "ReferenceCitation":"Vianello A, Fusello M, Gubian L, Rinaldo C, Dario C, Concas A, Saccavini C, Battistella L, Pellizzon G, Zanardi G, Mancin S. Home telemonitoring for patients with acute exacerbation of chronic obstructive pulmonary disease: a randomized controlled trial. BMC Pulm Med. 2016 Nov 22;16(1):157."
              }
            ]
          },
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"The Renewing Health project is partially funded under the ICT Policy Support Programme (ICT PSP) as part of the Competitiveness and Innovation Framework Programme by the European Community",
                "SeeAlsoLinkURL":"http://www.renewinghealth.eu"
              }
            ]
          }
        },
        "IPDSharingStatementModule":{
          "IPDSharing":"No"
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000008171",
                "ConditionMeshTerm":"Lung Diseases"
              },{
                "ConditionMeshId":"D000029424",
                "ConditionMeshTerm":"Pulmonary Disease, Chronic Obstructive"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000012140",
                "ConditionAncestorTerm":"Respiratory Tract Diseases"
              },{
                "ConditionAncestorId":"D000008173",
                "ConditionAncestorTerm":"Lung Diseases, Obstructive"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M9751",
                "ConditionBrowseLeafName":"Lung Diseases",
                "ConditionBrowseLeafAsFound":"Pulmonary Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9753",
                "ConditionBrowseLeafName":"Lung Diseases, Obstructive",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M22033",
                "ConditionBrowseLeafName":"Pulmonary Disease, Chronic Obstructive",
                "ConditionBrowseLeafAsFound":"Pulmonary Disease, Chronic Obstructive",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M13560",
                "ConditionBrowseLeafName":"Respiratory Tract Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC08",
                "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}