{
  "FullStudy":{
    "Rank":218109,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512615",
          "OrgStudyIdInfo":{
            "OrgStudyId":"RHCopenHeartIE"
          },
          "Organization":{
            "OrgFullName":"Rigshospitalet, Denmark",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"CopenHeart IE - Integrated Rehabilitation of Patients Treated for Infective Endocarditis",
          "OfficialTitle":"CopenHeart IE - A Randomized Clinical Trial Investigating the Effect and Meaning of Integrated Rehabilitation Versus Usual Follow-up of Patients Treated for Infective Endocarditis"
        },
        "StatusModule":{
          "StatusVerifiedDate":"September 2019",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"December 2011",
            "StartDateType":"Actual"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"October 2016",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"October 15, 2018",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 11, 2012",
          "StudyFirstSubmitQCDate":"January 14, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 10, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"September 11, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Selina Kikkenborg Berg",
            "ResponsiblePartyInvestigatorTitle":"Principal investigator",
            "ResponsiblePartyInvestigatorAffiliation":"Rigshospitalet, Denmark"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Rigshospitalet, Denmark",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"University Hospital, Gentofte, Copenhagen",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Copenhagen Trial Unit, Center for Clinical Intervention Research",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The aim of the study is to describe the effect and meaning of an integrated rehabilitation programme, consisting of physical training and psycho-educational care, for patients treated for infective endocarditis.\n\nThe hypothesis is, that integrated rehabilitation can improve mental health, physical capacity and other factors.",
          "DetailedDescription":"Infective endocarditis (IE) is among the most serious infectious diseases in the western world. Treatment requires lengthy hospitalization, high dosage antibiotics and possible valve replacement surgery. Studies indicate that patients experience persisting physical symptoms, diminished quality of life and difficulties returning to work, up to a year post-discharge. No studies investigating the effect of, interventions aimed at relieving these problems, have been published.\n\nA randomized clinical trial is conducted to investigate the effect and meaning of an integrated rehabilitation programme on the physical and psychosocial functioning of patients treated for IE. The trial is a multi-centre, parallel arm design. A mixed methods embedded experimental design is chosen to include both quantitative and qualitative data to evaluate the intervention. The intervention consists of five psycho-educational consultations provided by specialized nurses and a twelve week individualized exercise training programme provided by physiotherapists. A qualitative and a survey-based pre-study will be undertaken, to investigate post-discharge experiences and rehabilitation needs of patients treated for IE. A qualitative post-intervention study will explore rehabilitation participation experiences.\n\nThe hypothesis is, that integrated rehabilitation can improve mental health, physical capacity, self-rated health, quality of life, nutritional status, sleep-quality and body-image and reduce anxiety, depression, fatigue, health care utilisation, work cessation and mortality in patients treated for IE and that it is cost effective.\n\n150 patients treated for leftsided- (native- or prosthetic valve) or cardiac device endocarditis will be included in the trial\n\nQuestionnaires, cardiopulmonary testing, 6 minute walking test and qualitative interviews will be used to evaluate the effect and meaning of the programme."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Infective Endocarditis"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Rehabilitation",
              "Exercise training",
              "Psycho-educational care"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignInterventionModelDescription":"RCT",
            "DesignPrimaryPurpose":"Prevention",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"117",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Intervention group",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Complex Cardiac Rehabilitation",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Complex Cardiac rehabilitation"
                  ]
                }
              },{
                "ArmGroupLabel":"Control group",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Usual care",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Control group"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"Complex Cardiac rehabilitation",
                "InterventionDescription":"Complex Cardiac Rehabilitation consisting of exercise training (minimum 3 times a week for a total of twelve weeks) and psychoeducational care (5 sessions over 6 months)",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Intervention group"
                  ]
                }
              },{
                "InterventionType":"Other",
                "InterventionName":"Control group",
                "InterventionDescription":"Usual care, clinical control as provided by treating heart centre",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Control group"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Change in Mental component scale",
                "PrimaryOutcomeDescription":"Measured by the mental component scale (MCS) in the SF-36 questionnaire",
                "PrimaryOutcomeTimeFrame":"1, 4, 6 and 12 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Change in physical capacity",
                "SecondaryOutcomeDescription":"Measured by Peak VO2 via ergospirometry testing",
                "SecondaryOutcomeTimeFrame":"1, 4 and 6 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatients:\n\ntreated for leftsided- (native- or prosthetic valve) or cardiac device endocarditis based on Duke Criteria\n18 years or older\nspeaking and understanding Danish\nproviding written informed consent\n\nExclusion Criteria:\n\nPatients:\n\nunable to understand study instructions\nwith an ischemic event within the past 6 months\nwho are pregnant or breastfeeding\nwith reduced ability to follow the planned programme due to i.e. substance abuse problems or other somatic illness\nwith considerable illness in the musculoskeletal system or with physical disability, which complicates exercise training\nwhose physician advise against participation",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"95 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Trine B Rasmussen, PhD fellow",
                "OverallOfficialAffiliation":"Copenhagen University Hospital Rigshospitalet, University Hospital Gentofte",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Selina K Berg, MScN, Ph.d.",
                "OverallOfficialAffiliation":"Copenhagen University Hospital Rigshospitalet, University Hospital Gentofte",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Ann-Dorthe Zwisler, MD, Ph.d.",
                "OverallOfficialAffiliation":"Copenhagen University Hospital Rigshospitalet, National Institute of Public Health, University of Southern Denmark",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Henning Bundgaard, MD, Ph.d.",
                "OverallOfficialAffiliation":"Rigshospitalet, Denmark",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Philip Moons, Prof, PhD",
                "OverallOfficialAffiliation":"Centre for Health Services and Nursing Research, KU Leuven—University of",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Rigshospitalet / gentofte hospital",
                "LocationCity":"Copenhagen",
                "LocationZip":"2100",
                "LocationCountry":"Denmark"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"24704921",
                "ReferenceType":"derived",
                "ReferenceCitation":"Rasmussen TB, Zwisler AD, Moons P, Berg SK. Insufficient living: experiences of recovery after infective endocarditis. J Cardiovasc Nurs. 2015 May-Jun;30(3):E11-9. doi: 10.1097/JCN.0000000000000144."
              },{
                "ReferencePMID":"23175738",
                "ReferenceType":"derived",
                "ReferenceCitation":"Rasmussen TB, Zwisler AD, Sibilitz KL, Risom SS, Bundgaard H, Gluud C, Moons P, Winkel P, Thygesen LC, Hansen JL, Norekvål TM, Berg SK; CopenHeartIE Group. A randomised clinical trial of comprehensive cardiac rehabilitation versus usual care for patients treated for infective endocarditis--the CopenHeartIE trial protocol. BMJ Open. 2012 Nov 21;2(6). pii: e001929. doi: 10.1136/bmjopen-2012-001929. Print 2012."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000004697",
                "ConditionMeshTerm":"Endocarditis, Bacterial"
              },{
                "ConditionMeshId":"D000004696",
                "ConditionMeshTerm":"Endocarditis"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000006331",
                "ConditionAncestorTerm":"Heart Diseases"
              },{
                "ConditionAncestorId":"D000002318",
                "ConditionAncestorTerm":"Cardiovascular Diseases"
              },{
                "ConditionAncestorId":"D000001424",
                "ConditionAncestorTerm":"Bacterial Infections"
              },{
                "ConditionAncestorId":"D000053821",
                "ConditionAncestorTerm":"Cardiovascular Infections"
              },{
                "ConditionAncestorId":"D000007239",
                "ConditionAncestorTerm":"Infection"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M6441",
                "ConditionBrowseLeafName":"Endocarditis",
                "ConditionBrowseLeafAsFound":"Endocarditis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M6442",
                "ConditionBrowseLeafName":"Endocarditis, Bacterial",
                "ConditionBrowseLeafAsFound":"Infective Endocarditis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8002",
                "ConditionBrowseLeafName":"Heart Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8866",
                "ConditionBrowseLeafName":"Infection",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4951",
                "ConditionBrowseLeafName":"Communicable Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3303",
                "ConditionBrowseLeafName":"Bacterial Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M26076",
                "ConditionBrowseLeafName":"Cardiovascular Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T3077",
                "ConditionBrowseLeafName":"Infective Endocarditis",
                "ConditionBrowseLeafAsFound":"Infective Endocarditis",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC01",
                "ConditionBrowseBranchName":"Bacterial and Fungal Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}