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

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06026293

Collaborator

Antonella Bianco (Other), Pietro Trisolini (Other), Giuseppe Dalfino (Other)

Enrollment

Location

3.4

Anticipated Duration (Months)

17.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
Non-Alcoholic Fatty Liver Disease

Study Design

Study Type:

Observational

Anticipated Enrollment :

58 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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)

Actual Study Start Date :

Jul 20, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Oct 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
subjects that participates to a previous clinical trial

Outcome Measures

Primary Outcome Measures

Cost/effectiveness Ratio [3 years]
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.

Secondary Outcome Measures

long term foresight of an healthy policy [3 years]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Being 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