Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-01-11 @ 12:02 AM
Study NCT ID:
NCT03019159
Status:
WITHDRAWN
Last Update Posted:
2017-01-12
First Post:
2017-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of a Follow-up With Tele-consulting for Patients With Renal Failure Under Peritoneal Dialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Support funding of the regional health authority stopped', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-10', 'studyFirstSubmitDate': '2017-01-10', 'studyFirstSubmitQcDate': '2017-01-10', 'lastUpdatePostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severe adverse events', 'timeFrame': 'Within 2 years after enrollment', 'description': 'Death, Peritonitis, acute pulmonary edema, symptomatic hyperkalemia or with EKG signs, severe and resistant hypertension, with uremia \\> 40 mmol/L'}], 'secondaryOutcomes': [{'measure': 'Number of hospitalisations', 'timeFrame': 'Within 2 years after enrollment'}, {'measure': 'Number of consultations', 'timeFrame': 'Within 2 years after enrollment'}, {'measure': 'Number of sanitary transportation', 'timeFrame': 'Within 2 years after enrollment'}, {'measure': 'Mean length of hospital stay', 'timeFrame': 'Within 2 years after enrollment'}, {'measure': 'Global costs', 'timeFrame': '6 months after the first patient enrollment'}, {'measure': 'Patients satisfaction', 'timeFrame': '1 year after enrollment'}, {'measure': 'Satisfaction of the professionnals', 'timeFrame': '6 months after enrollment of the first patient'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Renal Failure', 'Peritoneal Dialysis']}, 'referencesModule': {'references': [{'pmid': '17785025', 'type': 'BACKGROUND', 'citation': 'Gallar P, Vigil A, Rodriguez I, Ortega O, Gutierrez M, Hurtado J, Oliet A, Ortiz M, Mon C, Herrero JC, Lentisco C. Two-year experience with telemedicine in the follow-up of patients in home peritoneal dialysis. J Telemed Telecare. 2007;13(6):288-92. doi: 10.1258/135763307781644906.'}, {'pmid': '22617736', 'type': 'BACKGROUND', 'citation': 'Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.'}], 'seeAlsoLinks': [{'url': 'http://www.renewinghealth.eu/assessment-method', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to determine whether tele-consulting for the follow up of patients with renal failure under peritoneal dialysis would not increase the risk of experiencing a severe adverse event'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with renal failure under peritoneal dialysis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient under peritoneal dialysis for more than three month\n* Patient thought to be able to perform peritoneal dialysis alone or with the help of health care professionnals\n* Patients or health care professionnals thought to be able to use telemedicine\n\nExclusion Criteria:\n\n* No DSL Network\n* No GSM Network\n* Patients who can not express their opposition to the participation to this study because of limited mental abilities'}, 'identificationModule': {'nctId': 'NCT03019159', 'acronym': 'HSMDP', 'briefTitle': 'Assessment of a Follow-up With Tele-consulting for Patients With Renal Failure Under Peritoneal Dialysis', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Efficacy and Cost-effectiveness Assessment of a Follow-up With Tele-consulting for Patients With Chronic Renal Failure Under Peritoneal Dialysis', 'orgStudyIdInfo': {'id': 'TLM-HSMDP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tele-consulting', 'description': 'One visit out of two takes place with teleconsulting and the other is a face-to-face consultation', 'interventionNames': ['Device: Teleconsulting']}, {'label': 'No tele-consulting'}], 'interventions': [{'name': 'Teleconsulting', 'type': 'DEVICE', 'otherNames': ['Telemedicine'], 'armGroupLabels': ['Tele-consulting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94410', 'city': 'Saint-Maurice', 'country': 'France', 'facility': 'CTIRC - Hôpitaux Saint Maurice', 'geoPoint': {'lat': 48.82182, 'lon': 2.42716}}], 'overallOfficials': [{'name': 'Stéphane Roueff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pôle CTIRC. Hôpitaux Saint Maurice'}, {'name': 'Isabelle Durand-Zaleski, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DRCD URC Eco. Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': "Agence Regionale de Sante d'Ile de France", 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}