ABCC tool

The "ABCC Alto Adige" study is a randomized intervention study, i.e. usual treatment

is extended to a portion of patients, while another portion of patients receives treatment

unchanged standard.

The study analyzes a tool called Assessment of Burden of Chronic Conditions (ABCC),

designed to comprehensively assess and report the burden and perception of chronic disease

in patients affected by them. This ABCC tool is already used successfully in general practice

in Holland.

The study will then be conducted on patients suffering from the aforementioned chronic diseases, cared for in the

General (Family) Medicine clinics in the South Tyrol area. Participants will be

divided into two groups. A group will be followed with the ABCC tool, which will allow self-evaluation

initially give the patient his state of health, commented on and evaluated with the results obtained for the treatment immediately afterwards during the medical examination, with his family doctor; while the other group will receive conventional care and treatment.

The main objective of the study is to discover how the perceived quality of life can change

by patients, after 18 months of using the innovative ABCC tool. Therefore, we will try to understand whether the ABCC tool can lead to an improvement in the quality of life

behavior and self-management of the chronic diseases the patient suffers from, all of this

the Healthcare System would also improve in management terms. Based on the

usage data, a cost-effectiveness analysis will be conducted to verify whether this type of

treatment also makes economic sense.

What are the risks?

There are no specific risks associated with participation in this study. No one is intended to be used

experimental drug. However, you will be informed promptly if they become available

information that may influence your willingness to continue participation.

Will my data remain anonymous?

All information related to your participation in this Study will be treated accordingly

strictly confidential in accordance with the rules of Good Clinical Practice (Legislative Decree 211/2003), as well as

to those relating to the protection and processing of personal data, pursuant to the Regulation

European no. 679/2016, so-called GDPR, and the Italian legislation currently in force regarding

Privacy.

The personal data will be associated with a code, from which it will be impossible to trace your identity:

only the investigating doctor will be able to link the code to your name.

The investigator doctor who will follow you in the study in question, the persons in charge of the

monitoring of the Study and the Regulatory Authorities may have access to your personal data,

in compliance with and with the limitations provided for by European Regulation no. 679/2016, by Legislative Decree 196/2003,

as amended by Legislative Decree 101/2018, and by the Guidelines of the Data Protection Guarantor

personal (resolution no. 52 of 07/24/2008 and subsequent amendments and additions). The assigned staff

the Firm is however obliged to maintain, in any case, the confidentiality of such information.

We ask you to refer to the Information Note on the processing of personal data, which will be provided to you

delivered together with this Information Sheet, to fully understand your rights in

matter.

Who can I contact for further information?

If you have any questions or would like further information, do not hesitate to contact your doctor

investigator responsible for the study and/or who proposed it to you

participation in this observational study.

Dr. Christian J. Wiedermann

Version no. 2 of 8.7.2023