- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06573619
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
-
-
-
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.
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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