NCT06573619

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

January 8, 2024

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

January 2, 2024

Last Update Submit

March 10, 2025

Conditions

Chronic Disease

Outcome Measures

Primary Outcomes (1)

  • The validation of the GMAS questionnaire in patients with chronic disease.

    The validation of the GMAS questionnaire in patients with chronic disease.

    1 year

Secondary Outcomes (1)

  • 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

Interventions

Validation of questionnaireOTHER

Validation of questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with chronic diseases

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daniele Napolitano

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Daniele Napolitano

    Fondazione Policlinico Universitario A. Gemelli, IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2024

First Posted

August 27, 2024

Study Start

January 8, 2024

Primary Completion

August 31, 2024

Study Completion

December 31, 2024

Last Updated

March 11, 2025

Record last verified: 2025-03

Locations

IT(1)