{
  "FullStudy":{
    "Rank":218285,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510301",
          "OrgStudyIdInfo":{
            "OrgStudyId":"MIHM"
          },
          "Organization":{
            "OrgFullName":"Göteborg University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Mobile Phone in Hypertension Management",
          "OfficialTitle":"Mastery and Autonomy in Management of Hypertension With a Mobile Self-report System"
        },
        "StatusModule":{
          "StatusVerifiedDate":"September 2016",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"March 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"June 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 11, 2012",
          "StudyFirstSubmitQCDate":"January 13, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 16, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 14, 2016",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"September 15, 2016",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Göteborg University",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to examine if a mobile phone-based self-report system, using the patient's own mobile phone, will improve adherence to treatment of hypertension and lead to personal involvement of the patient in the treatment."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Hypertension"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Self-report",
              "Self-management",
              "Hypertension",
              "Adherence",
              "Cell phone",
              "Drug treatment",
              "Medical Adherence"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Supportive Care",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"51",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Self-report",
                "ArmGroupType":"Other",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Mobile phone-based self-report system, electronic Patient-Reported Outcomes Measure (e-PROM)"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"Mobile phone-based self-report system, electronic Patient-Reported Outcomes Measure (e-PROM)",
                "InterventionDescription":"To test an electronic Patient-Reported Outcomes Measure (e-PROM) intended to assess patients' daily perceptions of symptoms and wellbeing, as well as self-measured blood pressure, treatment side-effects and medicine intake;\n\nExplore patient interactions (learning and understanding) with an internet-reporting system providing structured feedback of e-PROM results to examine if such feedback is useful in improving adherence;\nExplore patient-physician/nurse interactions to examine if structured feedback of e-PROM results serves as a useful complement to support consultations regarding treatment monitoring and adherence.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Self-report"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Adherence to antihypertensive medication",
                "PrimaryOutcomeDescription":"Adherence to antihypertensive medication will be checked through a question in the cell phone and evaluation of patient´s use of antihypertensive medication will be checked from the National Prescribed Drug Register of drugs. Twenty patient-physician/nurse consultations will be audio/video-recorded at regularly scheduled appointments to obtain authentic evidence of the use of the self-reports in clinical practice. The outcomes will include blood pressure measurement, registration of self-reported symptoms and discourse analyses.",
                "PrimaryOutcomeTimeFrame":"8 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Systolic blood pressure",
                "SecondaryOutcomeDescription":"Change in systolic blood pressure",
                "SecondaryOutcomeTimeFrame":"8 weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nDiagnosis of arterial hypertension\nPrescribed antihypertensive treatment\nAlert and oriented\nSwedish-speaking\nAccess to a functioning cell phone\nAgreeing to regular controls at the National Prescribed Drug Register of drugs",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"30 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Karin I Kjellgren, professor",
                "OverallOfficialAffiliation":"Göteborg University",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"University of Gothenburg",
                "LocationCity":"Gothenburg",
                "LocationState":"Box 457",
                "LocationZip":"40530",
                "LocationCountry":"Sweden"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"24564289",
                "ReferenceType":"result",
                "ReferenceCitation":"Bengtsson U, Kasperowski D, Ring L, Kjellgren K. Developing an interactive mobile phone self-report system for self-management of hypertension. Part 1: patient and professional perspectives. Blood Press. 2014 Oct;23(5):288-95. doi: 10.3109/08037051.2014.883203. Epub 2014 Feb 24."
              },{
                "ReferencePMID":"24786778",
                "ReferenceType":"result",
                "ReferenceCitation":"Bengtsson U, Kjellgren K, Höfer S, Taft C, Ring L. Developing an interactive mobile phone self-report system for self-management of hypertension. Part 2: content validity and usability. Blood Press. 2014 Oct;23(5):296-306. doi: 10.3109/08037051.2014.901009. Epub 2014 May 1."
              },{
                "ReferencePMID":"24910510",
                "ReferenceType":"result",
                "ReferenceCitation":"Hallberg I, Taft C, Ranerup A, Bengtsson U, Hoffmann M, Höfer S, Kasperowski D, Mäkitalo A, Lundin M, Ring L, Rosenqvist U, Kjellgren K. Phases in development of an interactive mobile phone-based system to support self-management of hypertension. Integr Blood Press Control. 2014 May 7;7:19-28. doi: 10.2147/IBPC.S59030. eCollection 2014."
              },{
                "ReferencePMID":"25903164",
                "ReferenceType":"result",
                "ReferenceCitation":"Hallberg I, Ranerup A, Kjellgren K. Supporting the self-management of hypertension: Patients' experiences of using a mobile phone-based system. J Hum Hypertens. 2016 Feb;30(2):141-6. doi: 10.1038/jhh.2015.37. Epub 2015 Apr 23."
              },{
                "ReferencePMID":"26456490",
                "ReferenceType":"result",
                "ReferenceCitation":"Bengtsson U, Kjellgren K, Hallberg I, Lindwall M, Taft C. Improved Blood Pressure Control Using an Interactive Mobile Phone Support System. J Clin Hypertens (Greenwich). 2016 Feb;18(2):101-8. doi: 10.1111/jch.12682. Epub 2015 Oct 12."
              },{
                "ReferencePMID":"26462732",
                "ReferenceType":"result",
                "ReferenceCitation":"Ruiz-Hurtado G, Ruilope LM. New Strategy to Control Blood Pressure: Interactive Mobile Phone Support. J Clin Hypertens (Greenwich). 2016 Feb;18(2):109-10. doi: 10.1111/jch.12683. Epub 2015 Oct 14."
              },{
                "ReferencePMID":"30139897",
                "ReferenceType":"derived",
                "ReferenceCitation":"Taft C, Hallberg I, Bengtsson U, Manhem K, Kjellgren K. Links between blood pressure and medication intake, well-being, stress, physical activity and symptoms reported via a mobile phone-based self-management support system: a cohort study in primary care. BMJ Open. 2018 Aug 23;8(8):e020849. doi: 10.1136/bmjopen-2017-020849."
              },{
                "ReferencePMID":"29343156",
                "ReferenceType":"derived",
                "ReferenceCitation":"Bengtsson U, Kjellgren K, Hallberg I, Lundin M, Mäkitalo Å. Patient contributions during primary care consultations for hypertension after self-reporting via a mobile phone self-management support system. Scand J Prim Health Care. 2018 Mar;36(1):70-79. doi: 10.1080/02813432.2018.1426144. Epub 2018 Jan 18."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000006973",
                "ConditionMeshTerm":"Hypertension"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000014652",
                "ConditionAncestorTerm":"Vascular Diseases"
              },{
                "ConditionAncestorId":"D000002318",
                "ConditionAncestorTerm":"Cardiovascular Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8607",
                "ConditionBrowseLeafName":"Hypertension",
                "ConditionBrowseLeafAsFound":"Hypertension",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M15983",
                "ConditionBrowseLeafName":"Vascular Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}