NCT06026293

Pharmacoeconomic Evaluation of the Cost/Effectiveness Ratio of Physical Exercise on Non-alcoholic Fatty Liver Disease

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)
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis·ClinicalTrials.govEnrolling by invitation
View on ClinicalTrials.gov
Study focus
Study type
Observational
Sponsor & location
Primary sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Location
Castellana Grotte, Italy
Timeline & enrollment
Phase
N/A
Start date
Jul 20, 2023
End date
Oct 30, 2023
Enrollment
58 participants
Primary outcome

Cost/effectiveness Ratio

Summary

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).
 
 Pharmacoeconomics, 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.
 
 The 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.
 
 Economic 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.
 
 The 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)

ICD-10 classifications
Alcoholic fatty liverAlcoholic liver disease, unspecifiedAlcoholic liver diseaseLiver disease, unspecifiedAlcoholic cirrhosis of liver
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06026293
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06026293 through Pure Global AI's free database. This phase not specified trial is sponsored by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis and is currently Enrolling by invitation. The study focuses on Non-Alcoholic Fatty Liver Disease. Target enrollment is 58 participants.

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