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

NCT ID: NCT06026293

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 58 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-20
• Study Completion Date: 2024-10-02

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)

Conditions

Non-Alcoholic Fatty Liver Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

subjects that participates to a previous clinical trial

No interventions assigned to this group

Eligibility Criteria

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

Exclusion Criteria

• Patient deceased
• Patient who does not agree to participate in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Antonella Bianco

UNKNOWN

Sponsor Role: collaborator

Pietro Trisolini

UNKNOWN

Sponsor Role: collaborator

Giuseppe Dalfino

UNKNOWN

Sponsor Role: collaborator

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

OTHER

Sponsor Role: lead

Responsible Party

Maurizio Gaetano Polignano

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maurizio Gaetano Polignano

Role: PRINCIPAL_INVESTIGATOR

IRCCS "Saverio de Bellis"

Locations

Irccs Saverio de Bellis

Castellana Grotte, Bari, Italy

Countries

Italy

Other Identifiers

CER_study

Identifier Type: -

Identifier Source: org_study_id