Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT02237404
Status:
COMPLETED
Last Update Posted:
2017-11-07
First Post:
2014-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Economic Evaluation and Communication in Remote Monitoring of People With Pacemakers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-06', 'studyFirstSubmitDate': '2014-08-25', 'studyFirstSubmitQcDate': '2014-09-08', 'lastUpdatePostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical features', 'timeFrame': '6 months', 'description': 'Selected variables from the medical history records:\n\n* Gender\n* Age\n* Indication for the implantation of the pacemaker.\n* Comorbidities\n* Pharmacological treatment\n* Vital signs\n* Pacemaker parameters'}], 'secondaryOutcomes': [{'measure': 'Health-Related Quality of Life', 'timeFrame': '6 months', 'description': 'EuroQol-5Dimensions (EQ-5D)'}, {'measure': 'Health-Related Quality of Life', 'timeFrame': '6 months', 'description': 'Minnesota Living With Heart Failure Questionnaire (MLHF)'}, {'measure': 'Safety', 'timeFrame': '6 months', 'description': '* Number of patients with Adverse Events\n* Type of Adverse Events diagnosed'}, {'measure': 'Consultations and Hospitalizations unscheduled', 'timeFrame': '6 months', 'description': 'Number of unscheduled visits and hospitalizations'}, {'measure': 'Direct costs', 'timeFrame': '6 months', 'description': "Direct costs taken into account:\n\n* Pacemakers' costs (device implanted)\n* Hospitalizations' costs\n* Consultations' costs (hospital)\n* Prescribed medical transport's cost\n* Health personnel costs\n* Pharmaceutical costs"}, {'measure': 'Indirect cost', 'timeFrame': '6 months', 'description': 'Maintenance of the medical consultation (hospital):\n\n* Electricity\n* Cleaning\n* Furniture\n* Health fungible\n* Equipment investment'}, {'measure': 'Informal costs', 'timeFrame': '6 months', 'description': 'Costs related to the care and displacements of patients to hospital:\n\n* Displacement costs to hospital\n* Accommodation costs\n* Cost of meals\n* Costs for caregivers'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Follow-Up studies', 'Biological Pacemakers', 'Telemedicine', 'Efficiency'], 'conditions': ['Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '31995558', 'type': 'DERIVED', 'citation': 'Lopez-Villegas A, Catalan-Matamoros D, Peiro S, Lappegard KT, Lopez-Liria R. Cost-utility analysis of telemonitoring versus conventional hospital-based follow-up of patients with pacemakers. The NORDLAND randomized clinical trial. PLoS One. 2020 Jan 29;15(1):e0226188. doi: 10.1371/journal.pone.0226188. eCollection 2020.'}, {'pmid': '31195650', 'type': 'DERIVED', 'citation': 'Lopez-Liria R, Lopez-Villegas A, Enebakk T, Thunhaug H, Lappegard KT, Catalan-Matamoros D. Telemonitoring and Quality of Life in Patients after 12 Months Following a Pacemaker Implant: the Nordland Study, a Randomised Trial. Int J Environ Res Public Health. 2019 Jun 5;16(11):2001. doi: 10.3390/ijerph16112001.'}, {'pmid': '30241511', 'type': 'DERIVED', 'citation': 'Lopez-Villegas A, Catalan-Matamoros D, Lopez-Liria R, Enebakk T, Thunhaug H, Lappegard KT. Health-related quality of life on tele-monitoring for users with pacemakers 6 months after implant: the NORDLAND study, a randomized trial. BMC Geriatr. 2018 Sep 21;18(1):223. doi: 10.1186/s12877-018-0911-3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to estimate the outcomes in health and cost of the follow-up of patients with pacemakers.\n\nThe initial hypothesize of this study is that remote monitoring of pacemaker will show a best relation of outcomes in costs and effectiveness than the conventional follow-up in hospital.', 'detailedDescription': 'Cardiovascular Diseases are a major cause of global morbidity and mortality, being responsible according to the World Health Organization of the 30% of overall mortality.\n\nSince 2001 that the first pacemaker of remote monitoring was implanted in Europe, more than 300,000 pacemaker have been implanted around the world. Despite this sharp expansion, the scientific evidence on economic evaluations of pacemaker with remote monitoring is very limited, and in our knowledge, studies including informal costs have not been conducted.\n\nIn the field of cardiology, telemedicine allows consultations with patients through monitoring systems and remote communication analyzing the ongoing heart rates of people with pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy and subcutaneous Holter. The use of remote monitoring may save time and efforts to both healthcare professionals and patients, including their informal caregivers, reducing the number of follow up visits to the hospital and reducing the associated costs with patient follow-up, which will help to improve sustainability of healthcare services.\n\nDuring the 06 months of study, the patients with implant of pacemakers of both groups will be assessed of the same parameters, in 3 different moments (pre-implant and months 1, and 6 post-implantation).\n\nPacemakers that are going to be used in the project:\n\n1. Remote monitoring group: Biotronik Estella SR-T and DR-T \\& Biotronik Evia SR-T and DR-T.\n2. Hospital monitoring group: St Jude Medical Endurity SR and DR \\& Sorin Reply 200 SR and DR.\n\nThe study will estimate: 1) The Clinical features of the patients. 2) The effectiveness through of administration of Health-Related Quality of Life questionnaires and 3) Finally, hospital and informal costs of patients with pacemakers will be estimated by the researches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be 18 years of age\n* Have a pacemaker implanted\n* Understand and be able to properly perform self-monitoring at home\n\nExclusion Criteria:\n\n* Be participating in another study\n* Refuse to participate in the study\n* Have implanted a different cardiac device to the pacemaker'}, 'identificationModule': {'nctId': 'NCT02237404', 'briefTitle': 'Economic Evaluation and Communication in Remote Monitoring of People With Pacemakers', 'organization': {'class': 'OTHER', 'fullName': 'University of Tromso'}, 'officialTitle': 'Sustainability of Cardiology Services: Economic Evaluation and Communication in Remote Monitoring of People With Pacemakers.', 'orgStudyIdInfo': {'id': '008WABELCMW2014A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Hospital monitoring of pacemakers', 'description': 'Patients have to go to the hospital to be monitorized'}, {'type': 'EXPERIMENTAL', 'label': 'Remote monitoring of pacemakers', 'description': 'Telemedicine System:\n\nPatients have not to go to the hospital to be monitorized', 'interventionNames': ['Device: Telemedicine System']}], 'interventions': [{'name': 'Telemedicine System', 'type': 'DEVICE', 'otherNames': ['Patients are monitorized from hospital'], 'description': 'Telemedicine System is used in remote monitoring group', 'armGroupLabels': ['Remote monitoring of pacemakers']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N - 8092', 'city': 'Bodø', 'state': 'Nordland', 'country': 'Norway', 'facility': 'Nordland Hospital', 'geoPoint': {'lat': 67.28267, 'lon': 14.37513}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tromso', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student', 'investigatorFullName': 'Antonio Lopez Villegas', 'investigatorAffiliation': 'University of Tromso'}}}}