Therapeutic Adherence in Patients With Chronic Diseases (GMAS-MCNT)

March 10, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Objectives of the study are:

  • The validation of the GMAS questionnaire in patients with chronic disease.
  • Measurement of the level of therapeutic adherence in patients with chronic illness.
  • Measurement of the level of therapeutic adherence in patients with chronic disease undergoing an experimental trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The research is multicentre and will be conducted at the Fondazione Policlinico Gemelli IRCCS in Rome as reference centre together with the other participating centres. Patients will be enrolled at the centres involved, either during visits or during their hospital stay.

Study Type

Observational

Enrollment (Actual)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Daniele Napolitano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with chronic diseases

Description

Inclusion Criteria:

  • Chronically ill;
  • Age 18 years or older;
  • Willingness to participate in the study;
  • Chronic illness diagnosed at least 3 months before the start of the study;
  • Reading and signing the informed consent.

Exclusion Criteria:

  • Reduced command of the Italian language;
  • Subjects suffering from severe psychiatric disorders;
  • Serious clinical conditions that do not permit completion of the questionnaire;
  • Refusal to sign the informed consent to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The validation of the GMAS questionnaire in patients with chronic disease.
Time Frame: 1 year
The validation of the GMAS questionnaire in patients with chronic disease.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of the level of therapeutic adherence in patients with chronic illness. Measurement of the level of therapeutic adherence in patients with chronic disease undergoing an experimental trial.
Time Frame: 1 year

Measurement of the level of therapeutic adherence in patients with chronic illness.

Measurement of the level of therapeutic adherence in patients with chronic disease undergoing an experimental trial.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Daniele Napolitano, Fondazione Policlinico Universitario A. gemelli, IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Actual)

August 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

August 23, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6227 - GMAS-MCNT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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