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

NCT06607445 | Recruiting

• 1 other identifier: MedeA21.01
• Study Type: observational
• Target: 6,445
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Drug Event

Outcome Measures

Primary Outcomes (1)

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

  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.

  December 2024

Study Arms (17)

Lusitania

Primary health care

Celtici

Oncology

Vettonia

Mental health

Turdulia

Internal medicine

Lácara

Nephrology

Tartessos

Neurology

Cancho Roano

Emergencies

Oretania

Cardiology

Carpetania

Rheumatology

Baeturia

Transplants

Endovélico

Infectious

Sirona

Clinical pharmacology

Gaudeamus

University of extremadura

Sucellus

Urology

Mnemosyne

Neurology-Vascular

Paidos

Pediatrics

Turuñuelo

Pneumology

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive sampling is a widely used non-probability sampling that, if performed correctly, can be considered as random sampling. In this case, patients are selected as they come for consultation and as long as they meet the inclusion criteria. SES patients are eligible for inclusion in the study, so that a minimum of 3000 participants are expected to be included in the study in order to ensure adequate frequency of genetic polymorphisms of pharmacogenetic relevance. During the Deployment Phase of the Prescription Support Program, it is estimated that an additional 4,000 to 8,000 patients will be included, with a target of 0.1% of the population of Extremadura.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Complejo Hospitalario Universitario de Badajoz: lead

Study Sites (1)

Complejo Hospitalario Universitario de Badajoz

Badajoz, 06080, Spain

RECRUITING

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 23, 2024
• Study Start: May 26, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

ES (1)