{
  "FullStudy":{
    "Rank":218080,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512992",
          "OrgStudyIdInfo":{
            "OrgStudyId":"RH_pilotCAT"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"EC Grant Agreement 250487",
                "SecondaryIdType":"Other Grant/Funding Number",
                "SecondaryIdDomain":"European Comission, Information Society and Media DG"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Catalan Agency for Health Information, Assessment and Quality",
            "OrgClass":"OTHER_GOV"
          },
          "BriefTitle":"Home Telehealth Follow-up After Hospital Discharge for Chronic Obstructive Pulmonary Disease (COPD) Patients",
          "OfficialTitle":"Renewing Health RCT in Catalonia for the Evaluation of Home Telehealth Follow-up After Hospital Discharge for COPD Patients"
        },
        "StatusModule":{
          "StatusVerifiedDate":"September 2013",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Active, not recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"April 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"October 2013",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2013",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 16, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 4, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"September 5, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Catalan Agency for Health Information, Assessment and Quality",
            "LeadSponsorClass":"OTHER_GOV"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Fundació TicSalut",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Hospital Clinic of Barcelona",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Hospital de Mataró",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to assess the effects of a complex telemedicine intervention as a part of an integrated care program for patients with chronic obstructive pulmonary disease (COPD) discharged from the hospital after disease exacerbation. Will be evaluated whether the intervention produces benefits in terms of mortality, reduction in hospital readmissions and health-related quality of life. In addition, the trial evaluates the economical and organizational impact of the new service and examines its acceptability by patients and health professionals."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Pulmonary Disease, Chronic Obstructive"
            ]
          }
        },
        "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":"380",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Home telehealth",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Home telehealth"
                  ]
                }
              },{
                "ArmGroupLabel":"Usual care",
                "ArmGroupType":"No Intervention"
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"Home telehealth",
                "InterventionDescription":"Patients receive tailored intervention according to their clinical complexity.\n\nAll patients in the intervention group receive:\n\nPersonalised care plan\nEducation on self-management\nAccess to a personalized online health folder\nAccess to Call center\nAccess to primary care and hospital specialists; follow-up visits for evaluation of clinical recovery and care plan adjustments (if needed).\n\nPatients with LOW complexity additionally receive:\n\nDaily videoconferences for the 1st week after discharge\nRemote monitoring for respiratory parameters. Sensors are selected on an individual basis by the medical specialists.\n\nPatients with HIGH complexity additionally receive:\n\nVideoconferences for at least 1 month after discharge, scheduled on an individual basis.\nRemote monitoring for respiratory parameters.\nOne monthly phone call from the call centre to promote and assess patient self-management.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Home telehealth"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Number of hospital readmissions",
                "PrimaryOutcomeTimeFrame":"3 months period"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Health related quality of life of the patients as measured by the SF-36 v2 questionnaire",
                "SecondaryOutcomeTimeFrame":"3 months - at baseline and study end"
              },{
                "SecondaryOutcomeMeasure":"Hospital anxiety and depression scale HADS",
                "SecondaryOutcomeTimeFrame":"3 months - at baseline and study end"
              },{
                "SecondaryOutcomeMeasure":"Lung condition as measured by FEV1",
                "SecondaryOutcomeTimeFrame":"3 months - at baseline and study end"
              },{
                "SecondaryOutcomeMeasure":"Condition-related health status measured by COPD Assessment Test (CAT)",
                "SecondaryOutcomeTimeFrame":"3 months - at baseline and study end"
              },{
                "SecondaryOutcomeMeasure":"Mortality",
                "SecondaryOutcomeTimeFrame":"3 months period"
              },{
                "SecondaryOutcomeMeasure":"Patients' Acceptance-Satisfaction measured by the WSD Questionnaire",
                "SecondaryOutcomeTimeFrame":"at the 3rd month of the telehealth intervention"
              },{
                "SecondaryOutcomeMeasure":"Time in days to first readmission",
                "SecondaryOutcomeTimeFrame":"3 months period"
              },{
                "SecondaryOutcomeMeasure":"Length of stay in days for each readmission",
                "SecondaryOutcomeTimeFrame":"3 months period"
              },{
                "SecondaryOutcomeMeasure":"Number of emergency room visits",
                "SecondaryOutcomeTimeFrame":"at the 3rd month (end of trial)"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nExacerbation of COPD\nAge > 40 years\nCapability to use the devices provided\nWilling to participate\n\nExclusion Criteria:\n\n• Participation in a previous COPD home telehealth study",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"40 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Josep Roca Torrent, MD",
                "OverallOfficialAffiliation":"Pulmonary Department - Hospital Clinic of Barcelona",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Hospital Germans Trias i Pujol",
                "LocationCity":"Badalona",
                "LocationState":"Catalonia",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Capio Hospital Universitari Sagrat Cor",
                "LocationCity":"Barcelona",
                "LocationState":"Catalonia",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital Clinic de Barcelona",
                "LocationCity":"Barcelona",
                "LocationState":"Catalonia",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital del Mar",
                "LocationCity":"Barcelona",
                "LocationState":"Catalonia",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital Plató",
                "LocationCity":"Barcelona",
                "LocationState":"Catalonia",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital de Mataró",
                "LocationCity":"Mataró",
                "LocationState":"Catalonia",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital Parc Taulí",
                "LocationCity":"Sabadell",
                "LocationState":"Catalonia",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Consorci Sanitari de Terrassa",
                "LocationCity":"Terrassa",
                "LocationState":"Catalonia",
                "LocationCountry":"Spain"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"16611656",
                "ReferenceType":"background",
                "ReferenceCitation":"Casas A, Troosters T, Garcia-Aymerich J, Roca J, Hernández C, Alonso A, del Pozo F, de Toledo P, Antó JM, Rodríguez-Roisín R, Decramer M; members of the CHRONIC Project. Integrated care prevents hospitalisations for exacerbations in COPD patients. Eur Respir J. 2006 Jul;28(1):123-30. Epub 2006 Apr 12."
              },{
                "ReferencePMID":"16620167",
                "ReferenceType":"background",
                "ReferenceCitation":"Finkelstein SM, Speedie SM, Potthoff S. Home telehealth improves clinical outcomes at lower cost for home healthcare. Telemed J E Health. 2006 Apr;12(2):128-36."
              },{
                "ReferencePMID":"20197355",
                "ReferenceType":"background",
                "ReferenceCitation":"Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K, Scott RE. Home telehealth for chronic obstructive pulmonary disease: a systematic review and meta-analysis. J Telemed Telecare. 2010;16(3):120-7. doi: 10.1258/jtt.2009.090812. Epub 2010 Mar 2. Review."
              }
            ]
          }
        }
      },
      "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"
              }
            ]
          }
        }
      }
    }
  }
}