Individual Risk Profiles for Adverse Drug Reactions in Geriatric Patients

ConditionsPolypharmacy Pharmacogenetics Pharmacogenomic Testing Drug-Related Side Effects and Adverse Reactions

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age70+

SponsorRWTH Aachen University

About this trial

This project will generate a prospective cohort of geriatric patients with polypharmacy which will be characterized for vulnerability profiles of adverse drug reactions.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

70 years or older

Current drug therapy with three or more drugs

Being a patient in the interdisciplinary polypharmacy consultation service of the geriatric university outpatient clinic

Sufficient mobility (minimum: Wheelchair mobility)

Disqualifiers

No sufficient communication possible

Patients classified as terminally ill by the medical staff

Patients, that are incapable to give their informed consent and who do not have a legal representative

Trial population

Patients admitted to the Interdisciplinary Polypharmacy Consultation Service of the Department of Geriatric's University Outpatient Clinic in cooperation with the Institute of Clinical Pharmacology

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Pharmacogenomic testing of a panel of important pharmacogenes to detect genetic variants and evaluate the association between genetically predicted and measured drug metabolism
Genetic
All planned interventions are explorative analyses of biological and genetic risk profiles that can contribute to patients' individual risk for adverse drug reactions, i.e. due to variability in drug metabolism
Adverse Drug Reaction detection
Other intervention
During appointments in the university outpatient clinic, patients will undergo a comprehensive adverse drug reaction (ADR) assessment based on an ADR diary they were handed at enrolment
Falls Efficacy Scale International (FES-I)
Other intervention
The FES-I wil be obtained to estimate fear of falling

Treatment groups

2,000 Participants

are divided into 1 treatment group

Group A: Patients admitted to interdisciplinary polypharmacy consultation service3 interventions

Trial outcomes

Primary outcomes

Identification of vulnerability profiles of adverse drug reactions

To investigate patient-specific risk profiles for adverse drug reactions, the focus of this study is on analizing patients' functional and cognitive status, pharmacogenetics, and individual metabolic capacity (phenotype/genotype relationship).

Time frame

February 2022 - February 2032

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RWTH Aachen University

Lead sponsor

B. Braun Foundation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: