Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2026-04-16 @ 11:12 AM
Study NCT ID:
NCT02401659
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2015-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Importance of Patient´s Satisfaction With Telemedicine Based on Monitoring Systems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2015-03-17', 'studyFirstSubmitQcDate': '2015-03-24', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Satisfaction with telemedicine measured by the questionnaire in evaluation', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Satisfaction with medical treatment measured by visual analog scale', 'timeFrame': '12 months'}, {'measure': 'Quality of Life measured by SF-36', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['remote monitoring', 'satisfaction', 'telemonitoring', 'quality of life'], 'conditions': ['Arrythmia']}, 'descriptionModule': {'briefSummary': "Valiosa is a national, multicenter and prospective post market study. The objectives of the study are to generate and validate an instrument to evaluate patient and clinician's satisfaction with remote monitoring and to create awareness of the importance of remote monitoring among patients, physicians and decision makers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with an implantable cardiac device and using CareLink® program for the remote monitoring of the device.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients- naïve in CareLink®:\n\n * First implant patients, who initiate in CareLink®\n * Replacements patients who initiate in CareLink.\n2. Long term users in CareLink®: patients in CareLink for more than a year.\n3. Both male and female\n4. More than 18 years old.\n5. Be at the disposal of using CareLink monitoring system.\n6. Complete informed consent and accept the conditions of CareLink system.\n\nExclusion Criteria:\n\n1. Less than 18 years old\n2. Suffer from any menthal pathology who prevents the patient to collaborate in the study.\n3. Be unable to understand or answer questionnaires in Spanish.\n4. Deny to continue in the study.'}, 'identificationModule': {'nctId': 'NCT02401659', 'acronym': 'VALIOSA', 'briefTitle': 'Importance of Patient´s Satisfaction With Telemedicine Based on Monitoring Systems', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'orgStudyIdInfo': {'id': 'T431 v 2.0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'naïve with CareLink', 'description': 'patients with a first implant of an implanted cardiac device naïve in CareLink or patients with a refill who have not used CareLink until the implant', 'interventionNames': ['Device: CareLinK']}, {'label': 'users of CareLink', 'description': 'patients with an implanted cardiac device who have used CareLink for more than one year', 'interventionNames': ['Device: CareLinK']}], 'interventions': [{'name': 'CareLinK', 'type': 'DEVICE', 'armGroupLabels': ['naïve with CareLink', 'users of CareLink']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vitoria-Gasteiz', 'state': 'Basque Country', 'country': 'Spain', 'facility': 'Hospital Universitario de Araba', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}, {'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Infanta Leonor', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}