Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-01-04 @ 7:00 PM
Study NCT ID:
NCT03708666
Status:
COMPLETED
Last Update Posted:
2018-10-17
First Post:
2018-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nephrocare mHealth Project: Telemonitoring of Blood Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-13', 'studyFirstSubmitDate': '2018-10-13', 'studyFirstSubmitQcDate': '2018-10-13', 'lastUpdatePostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic and diastolic blood pressure under control', 'timeFrame': '6 months', 'description': 'Percentage of patients with blood pressure within target limits'}], 'secondaryOutcomes': [{'measure': 'Adaptations of treatment', 'timeFrame': '6 months', 'description': 'Percentage of change in hypertension therapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Diseases', 'Blood Pressure']}, 'descriptionModule': {'briefSummary': 'The Nephrocare mHealth project supports patients with Chronic Kidney Disease with a mobile application and telemonitoring. The application includes the follow-up of blood pressure.', 'detailedDescription': 'Patients that are included in the Nephrocare mHealth project send their blood pressure results through an app or online website.\n\nThe clinical decision support system will alert the patient, as well as the general practitioner and the hospital when the blood pressure is too high or low. In addition the clinical decision support will calculate monthly averages and all the data are connected with the electronic patient files.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dutch-speaking\n* Signed and approved informed consent\n* Follow-up by nephrology at the University Hospitals Leuven or General Hospital Groeninge\n\nExclusion Criteria:\n\n* No Dutch-speaking\n* Impaired cognitive condition or medically unstable'}, 'identificationModule': {'nctId': 'NCT03708666', 'acronym': 'Nephrocare', 'briefTitle': 'Nephrocare mHealth Project: Telemonitoring of Blood Pressure', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Nephrocare mHealth: Improvement of Patient Empowerment and Self-management by the Use of Telemonitoring.', 'orgStudyIdInfo': {'id': 'S60335'}, 'secondaryIdInfos': [{'id': 'AZGS2017056', 'type': 'OTHER', 'domain': 'AZ Groeninge'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Telemonitoring of blood pressure', 'description': 'Patients measure their blood pressure and register their results on the app or website.', 'interventionNames': ['Other: Telemonitoring of blood pressure']}], 'interventions': [{'name': 'Telemonitoring of blood pressure', 'type': 'OTHER', 'description': 'Blood pressure monitoring at least once a week.', 'armGroupLabels': ['Telemonitoring of blood pressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Kathleen Claes, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'General Hospital Groeninge', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. K. Claes', 'investigatorFullName': 'Kathleen Claes', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}