Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-01-02 @ 12:34 PM
Study NCT ID:
NCT05786092
Status:
UNKNOWN
Last Update Posted:
2023-03-27
First Post:
2023-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Telemonitoring on Metabolic Variables in Severe Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-15', 'studyFirstSubmitDate': '2023-03-15', 'studyFirstSubmitQcDate': '2023-03-15', 'lastUpdatePostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'changes in blood pressure registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up.', 'timeFrame': '12 months', 'description': 'Variation in blood pressure between the time of discharge and 11 months in patients undergoing the two different strategies in studies'}, {'measure': 'changes in heart rate registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up.', 'timeFrame': '12 months', 'description': 'Variation in heart rate between the time of discharge and 11 months in patients undergoing the two different strategies in studies'}, {'measure': 'changes in oxygen saturation registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up.', 'timeFrame': '12 months', 'description': 'Variation in oxygen saturation between the time of discharge and 11 months in patients undergoing the two different strategies in studies'}, {'measure': 'changes in blood glucose registered at month 11 in patients followed-up by telemedicine and in patients undergoing traditional outpatient visit follow-up.', 'timeFrame': '12 months', 'description': 'Variation in blood glucose between the time of discharge and 11 months in patients undergoing the two different strategies in studies'}], 'primaryOutcomes': [{'measure': '+ dropout rate at month 11 of patients followed-up by a telemedicine methodology with that of a traditional outpatient visit follow-up.', 'timeFrame': '12 months', 'description': 'Percentage of patients still in care at month 11 after discharge in each of the two subgroups.'}], 'secondaryOutcomes': [{'measure': 'amount of weight loss at month 11 in patients followed-up by telemedicine with that registered in patients followed-up by traditional outpatient visits.', 'timeFrame': '12 months', 'description': 'Percentage of patients with weight loss of at least 5% and percentage of patients with weight loss between 0% and 5% at month 11 in each of the two subgroups.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Severe Obesity']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare, in a population of severely obese patients, two different kinds of follow-up after discharge from in-hospital rehabilitation programme.\n\nThe main questions addressed are:\n\n* primary outcome: comparing the dropout rate at month 11 of patients followed-up by a telemedicine methodology with that of a traditional outpatient visit follow-up.\n* secondary outcome: comparing the amount of weight loss at month 11 in patients followed-up by telemedicine with that registered in patients followed-up by traditional outpatient visits.\n\nParticipants are given a set of instruments (scale, activity tracker, automatic blood pressure monitor, oxymeter, and glucometer) and asked to measure vital parameters following a predetermined schedule for one year. Subjects are asked to engage in regular physical activity and follow the nutritional guidelines received at the moment of discharge from hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 38-60 kg/m2,\n* age between 18 and 65 years,\n* patient residing in Piedmont, Lombardy\n* Recent admission to San Giuseppe Hospital in Piancavallo for a period of residential rehabilitation.\n* Patient with wi-fi and/or mobile data connection at home.\n\nExclusion Criteria:\n\n* illiteracy\n* inability to engage in physical activity\n* psychiatric illnesses capable of impairing the proper use of the devices provided by telemonitoring\n* cognitive impairment, mental retardation\n* predictability of long periods of stay abroad\n* anticipation or planning of pregnancy during the year following discharge\n* legal protection'}, 'identificationModule': {'nctId': 'NCT05786092', 'acronym': 'teleob', 'briefTitle': 'Impact of Telemonitoring on Metabolic Variables in Severe Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Auxologico Italiano'}, 'officialTitle': 'The Role of Home Telemonitoring in the Evaluation of Patients With Severe Obesity After a Period of Residential Metabolic Rehabilitation.', 'orgStudyIdInfo': {'id': '18C020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment', 'interventionNames': ['Device: Telemonitoring']}, {'type': 'NO_INTERVENTION', 'label': 'control'}], 'interventions': [{'name': 'Telemonitoring', 'type': 'DEVICE', 'description': 'Monitoring of the required parameters by means of the data provided by the devices used by patients. The data (weight, body composition, blood pressure, oxygen saturation, physical activity, heart rate and blood glucose) collected according to the predetermined schedule are then saved in a cloud accessible to researchers.', 'armGroupLabels': ['treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28824', 'city': 'Oggebbio', 'state': 'VCO', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Sara P. Mambrini', 'role': 'CONTACT', 'email': 's.mambrini@auxologico.it', 'phone': '+390323514512'}], 'facility': 'Istituto Auxologico Italiano', 'geoPoint': {'lat': 45.99088, 'lon': 8.64663}}], 'centralContacts': [{'name': 'Massimo Scacchi', 'role': 'CONTACT', 'email': 'massimo.scacchi@unimi.it', 'phone': '+390323514301'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}