Evaluation of the Implementation of the Pharmacogenetics and Personalized Medicine Program "MedeA" in the Extremadura Health Service.

Recruiting

• Conditions: Adverse Drug Event

• Registration Number: NCT06607445
• Lead Sponsor: Complejo Hospitalario Universitario de Badajoz

Brief Summary

An open longitudinal observational study, non-randomized, which will include the adult population, attended by the SES, in which preference will be given to those patients under treatment with drugs that can produce relevant adverse effects. It is a naturalistic study in which no pharmacological or other type of intervention will be carried out, only the information recommended in the drug data sheet (pharmacogenetic biomarkers, relevant interactions and clinical contraindications) will be provided.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-26
• Status Verified: 2024-09
• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-18
• Last Update Submitted: 2024-09-18
• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6445

Inclusion Criteria

Patients with a recent diagnosis and who are to be or are being treated according to usual clinical practice, who meet the criteria to participate in the study, read the corresponding information sheet, sign informed consent and agree to participate, provided they meet the following inclusion criteria:

General criteria for all patients:

• Age ≥ 18 years. In case of minors, they may be included, under the following assumptions:
• If the minor is under 12 years of age, participation will require the consent and signature of the informed consent document by both parents (or their guardian).
• If the minor is between 12 and 16 years of age, a proxy informed consent form will be provided and signed by both parents (if both parents are present at the time of the interview) or only one of them (in which case one of the following two conditions must be stated: that the other parent is not present at the time of the interview but does not object to the participation of the minor in the study or that the signatory is the sole legal guardian of the minor).
• Be registered or potentially/have been attended in the Extremadura Health Service.
• Not have language or communication barrier or present disability being totally dependent on another person.

Exclusion Criteria

• Failure to meet any of the inclusion criteria described above.
• Refusal by the patient to be part of the cohort initially, or to continue to be part of the cohort during follow-up.
• Manifest difficulty for follow-up.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the implementation of the Pharmacogenetics and Personalized Medicine Program "MedeA" in the Extremadura Health Service.	December 2024	To analyze the implementation in the clinical routine of a pharmacogenetics and personalized medicine program in SES patients, evaluating the overall impact on the health system, and at the individual level, general modifications in the clinical response and its temporal evolution.

Trial Locations

Locations (1)

Complejo Hospitalario Universitario de Badajoz; 🇪🇸 Badajoz, Spain