{
  "FullStudy":{
    "Rank":218005,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513993",
          "OrgStudyIdInfo":{
            "OrgStudyId":"G. A. 250487-Veneto WP8Cl7"
          },
          "Organization":{
            "OrgFullName":"Regione Veneto",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Remote Monitoring of Chronic Heart Failure in Veneto Region",
          "OfficialTitle":"RENEWING HEALTH - Large Scale Pilot in Veneto Region: Remote Monitoring of Chronic Heart Failure"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"October 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":"October 27, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"October 28, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "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 7 Conegliano",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Azienda ULSS 16 Padova",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Azienda ULSS di Verona e Provincia",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Azienda ULSS 12 Veneziana",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Azienda Unità Socio Sanitaria di Dolo Mirano",
                "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 telemonitoring of patients with chronic heart failure produces a reduction in the combined end point of all cause mortality and number of hospitalisations, and whether it improves health related quality of life. In addition, the trials evaluate the economic and organisational impact of the telemonitoring service and examine its acceptability by patients and health professionals.",
          "DetailedDescription":"The study is designed to evaluate the impact of telemonitoring on the management of CHF compared with outpatient usual care. From a clinical point of view, the trial will allow to investigate how telemonitoring contributes to reduct the combined end point of all cause mortality and re-hospitalizations, as well as the other kinds of access to hospital facilities (bed-days, specialistic and ER visits). The trial will examine whether the CHF patients improve their health-related quality of life and reduct the anxiety about health conditions, thanks to the telemonitoring. 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 professional perception towards the service."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Congestive Heart Failure"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "CHF",
              "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":"315",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Control group",
                "ArmGroupType":"No Intervention",
                "ArmGroupDescription":"Treatment as usual"
              },{
                "ArmGroupLabel":"Telemonitoring for patients with Congestive Heart Failure",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Telemonitoring for patients with Congestive Heart Failure"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"Telemonitoring for patients with Congestive Heart Failure",
                "InterventionDescription":"Patients are equipped with a telemonitoring kit composed by a portable wrist-clinic device and digital weight scale for clinical parameters measuring and a gateway device for data transmission.\n\nThe patient can monitor a complete set of clinical parameters, such as pulse-oxymetry, heart rate, blood pressure, ECG and body weight, 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 alerts the reference clinician in case of worsening of symptoms.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Telemonitoring for patients with Congestive Heart Failure"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Combined end point of all cause mortality and number of hospitalisations for heart failure",
                "PrimaryOutcomeTimeFrame":"12 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Cardiovascular and all-cause mortality",
                "SecondaryOutcomeTimeFrame":"12 months"
              },{
                "SecondaryOutcomeMeasure":"Health-Related Quality of Life",
                "SecondaryOutcomeDescription":"Health-Related Quality of Life is assessed by the SF-36 questionnaire",
                "SecondaryOutcomeTimeFrame":"12 months"
              },{
                "SecondaryOutcomeMeasure":"Number of hospitalisations (including rehospitalisations) for all causes and for heart failure",
                "SecondaryOutcomeTimeFrame":"12 months"
              },{
                "SecondaryOutcomeMeasure":"Total number of days in hospital",
                "SecondaryOutcomeTimeFrame":"12 months"
              },{
                "SecondaryOutcomeMeasure":"Number of specialist visits",
                "SecondaryOutcomeTimeFrame":"12 months"
              },{
                "SecondaryOutcomeMeasure":"Number of visits at emergency department for heart failure",
                "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"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAge ≥ 65 years.\nDischarge from hospital after acute heart failure in the previous 3 months and EF < 40% or EF > 40% plus BNP > 400 (or plus NT-proBNP>1500) during hospitalization\n\nExclusion Criteria:\n\nComorbidities prevalent on CHF with life expectation < 12 months.\nImpossibility or inability to use the equipment and help at home not available.\nMyocardial infarction or percutaneous coronary intervention in the last 3 months or scheduled.\nCoronary artery bypass, valve substitution or correction in the last 6 months.\nBeing on waiting list for heart transplantation.\nBeing enrolled in other trial",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Zoran Olivari, DM",
                "OverallOfficialAffiliation":"Azienda Unità Locale Socio Sanitaria n.9 Treviso",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Ospedale Immacolata Concezione - Cardiology Department",
                "LocationCity":"Piove di Sacco",
                "LocationState":"Padova",
                "LocationZip":"35028",
                "LocationCountry":"Italy"
              },{
                "LocationFacility":"Presidio ospedaliero di Conegliano - Department of Cardiology",
                "LocationCity":"Conegliano",
                "LocationState":"Treviso",
                "LocationZip":"31015",
                "LocationCountry":"Italy"
              },{
                "LocationFacility":"Ospedale di Mirano - Cardiology Department",
                "LocationCity":"Mirano",
                "LocationState":"Venezia",
                "LocationZip":"30035",
                "LocationCountry":"Italy"
              },{
                "LocationFacility":"Ospedale San Fracastoro - Cardiology Department",
                "LocationCity":"San Bonifacio",
                "LocationState":"Verona",
                "LocationZip":"37047",
                "LocationCountry":"Italy"
              },{
                "LocationFacility":"Azienda Ospedaliera di Padova - Cardiology Department",
                "LocationCity":"Padova",
                "LocationZip":"35128",
                "LocationCountry":"Italy"
              },{
                "LocationFacility":"Ospedale Ca'Foncello - Pulmonology Department",
                "LocationCity":"Treviso",
                "LocationZip":"31100",
                "LocationCountry":"Italy"
              },{
                "LocationFacility":"Ospedale SS Giovanni e Paolo - Cardiology Department",
                "LocationCity":"Venezia",
                "LocationZip":"30122",
                "LocationCountry":"Italy"
              },{
                "LocationFacility":"Azienda Ospedaliera Universitaria Integrata di Verona - Geriatric Medicine Department",
                "LocationCity":"Verona",
                "LocationZip":"37124",
                "LocationCountry":"Italy"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"19687005",
                "ReferenceType":"background",
                "ReferenceCitation":"Scherr D, Kastner P, Kollmann A, Hallas A, Auer J, Krappinger H, Schuchlenz H, Stark G, Grander W, Jakl G, Schreier G, Fruhwald FM; MOBITEL Investigators. Effect of home-based telemonitoring using mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation: randomized controlled trial. J Med Internet Res. 2009 Aug 17;11(3):e34. doi: 10.2196/jmir.1252."
              },{
                "ReferencePMID":"17426062",
                "ReferenceType":"background",
                "ReferenceCitation":"Clark RA, Inglis SC, McAlister FA, Cleland JG, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ. 2007 May 5;334(7600):942. Epub 2007 Apr 10. Review."
              },{
                "ReferencePMID":"21733889",
                "ReferenceType":"background",
                "ReferenceCitation":"Inglis SC, Clark RA, McAlister FA, Stewart S, Cleland JG. Which components of heart failure programmes are effective? A systematic review and meta-analysis of the outcomes of structured telephone support or telemonitoring as the primary component of chronic heart failure management in 8323 patients: Abridged Cochrane Review. Eur J Heart Fail. 2011 Sep;13(9):1028-40. doi: 10.1093/eurjhf/hfr039. Epub 2011 Jul 6."
              },{
                "ReferencePMID":"21080835",
                "ReferenceType":"background",
                "ReferenceCitation":"Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16. Erratum in: N Engl J Med. 2011 Feb 3;364(5):490. N Engl J Med. 2013 Nov 7;369(19):1869."
              },{
                "ReferencePMID":"19850208",
                "ReferenceType":"background",
                "ReferenceCitation":"Klersy C, De Silvestri A, Gabutti G, Regoli F, Auricchio A. A meta-analysis of remote monitoring of heart failure patients. J Am Coll Cardiol. 2009 Oct 27;54(18):1683-94. doi: 10.1016/j.jacc.2009.08.017. Review. Erratum in: J Am Coll Cardiol. 2010 May 11;55(19):2185."
              },{
                "ReferencePMID":"20687083",
                "ReferenceType":"background",
                "ReferenceCitation":"Inglis SC, Clark RA, McAlister FA, Ball J, Lewinter C, Cullington D, Stewart S, Cleland JG. Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007228. doi: 10.1002/14651858.CD007228.pub2. Review. Update in: Cochrane Database Syst Rev. 2015;10:CD007228."
              }
            ]
          },
          "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"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000006333",
                "ConditionMeshTerm":"Heart Failure"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000006331",
                "ConditionAncestorTerm":"Heart Diseases"
              },{
                "ConditionAncestorId":"D000002318",
                "ConditionAncestorTerm":"Cardiovascular Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8004",
                "ConditionBrowseLeafName":"Heart Failure",
                "ConditionBrowseLeafAsFound":"Heart Failure",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8002",
                "ConditionBrowseLeafName":"Heart Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}