Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 11:30 PM
Study NCT ID:
NCT06026293
Status:
COMPLETED
Last Update Posted:
2024-10-09
First Post:
2023-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacoeconomic Evaluation of the Cost/effectiveness Ratio of Physical Exercise on Non-alcoholic Fatty Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-05', 'studyFirstSubmitDate': '2023-08-30', 'studyFirstSubmitQcDate': '2023-09-06', 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cost/effectiveness Ratio', 'timeFrame': '3 years', 'description': 'to define the economic value in terms of CER (Cost/Effectiveness Ratio) and ICER (Incremental Cost/Effectivness Ratio) of physical exercise in the treatment of NAFLD in patients who already have comorbidities for metabolic/cardiometabolic diseases.'}], 'secondaryOutcomes': [{'measure': 'long term foresight of an healthy policy', 'timeFrame': '3 years', 'description': 'identify the potential savings in terms of costs (direct and indirect) of physical exercise on patients suffering from NAFLD through the use of a predictive scenario developed through the use of the MAFEIP (Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Aging).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-alcoholic fatty liver desease', 'Cost/effectivness', 'Physical activity'], 'conditions': ['Non-Alcoholic Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': 'Physical inactivity and poor dietary habits are associated with an increased risk of obesity and chronic disease (World Health Organization, 2019; Glanz and Bishop, 2010). Conversely, higher levels of total physical activity result in a reduced risk of cardiovascular disease, breast and colon cancer, and diabetes (Kyu et al., 2016). Similarly, consumption of the minimum recommended level (600 g per day) of fruit and vegetables is associated with a lower risk of cardiovascular disease and cancer (Ezzati et al., 2004). However, despite these recognized benefits, unhealthy diet and physical inactivity are still major contributors to poor health and rising health care costs. Worldwide, physical inactivity accounted for 13.4 million disability-adjusted life years (DALYs) in 2013 and cost $53.8 billion to health systems and an additional $13.7 billion in productivity due to deaths attributable to physical inactivity (Ding et al., 2016).\n\nPharmacoeconomics, or the economic evaluation of treatments aimed at maintaining the health of the population, is a set of evaluation models used to identify the value (convenience) and the overall economic impact of a possible treatment.\n\nThe results of economic evaluations help decision makers inform their choice. Their advantage is that the result is obtained by applying known and validated models, and everyone can know the basis of the decision (evidence-based decision making). The clinical-economic value and the overall financial impact must be compared with the willingness to pay the related costs.\n\nEconomic evaluations are a tool for defining the value of a medicine in terms of cost-opportunity, from the point of view of the patient, the NHS and society as a whole.\n\nThe definition of "value" is very broad, multidimensional and includes concepts from many disciplines, beyond economics. Specifically, economic evaluations that take into consideration new medicines, innovative or not, the value is given by the marginal utility that the patient, the NHS and/or society can obtain from its acquisition. In this regard, the measurement of years of life gained in full quality of life (QALY - quality-adjusted life years) is widely applied to medicines in various regulatory contexts, albeit with the awareness that it is not able to capture all the elements that contribute to value (Carletto, A et al.; Drummond, M. F)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The population was affected by NAFLD in the observation period (2018-2020), participating in health promotion activities by performing physical exercise under the supervision of the institution's kinesiologists", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Being affected by NAFLD in the observation period (2018-2020)\n* Participating in health promotion activities by performing physical exercise under the supervision of the institution's kinesiologists\n\nExclusion Criteria:\n\n* Patient deceased\n* Patient who does not agree to participate in the study"}, 'identificationModule': {'nctId': 'NCT06026293', 'briefTitle': 'Pharmacoeconomic Evaluation of the Cost/effectiveness Ratio of Physical Exercise on Non-alcoholic Fatty Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis'}, 'officialTitle': 'Retrospective and Prospective Study Aimed At the Pharmacoeconomic Evaluation of the Cost/effectiveness Ratio of Physical Exercise on the Prognosis of Non-alcoholic Fatty Liver Disease (NAFLD)', 'orgStudyIdInfo': {'id': 'CER_study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'subjects that participates to a previous clinical trial'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70013', 'city': 'Castellana Grotte', 'state': 'Bari', 'country': 'Italy', 'facility': 'Irccs Saverio de Bellis', 'geoPoint': {'lat': 40.88643, 'lon': 17.16549}}], 'overallOfficials': [{'name': 'Maurizio Gaetano Polignano', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS "Saverio de Bellis"'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Antonella Bianco', 'class': 'UNKNOWN'}, {'name': 'Pietro Trisolini', 'class': 'UNKNOWN'}, {'name': 'Giuseppe Dalfino', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Maurizio Gaetano Polignano', 'investigatorAffiliation': 'Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis'}}}}