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Individual Risk Profiles for Adverse Drug Reactions in Geriatric Patients

Individual Patient Risk Profiles for Adverse Drug Reactions: Establishing a Consecutive Research Cohort in an Interdisciplinary Polypharmacy Consultation Service of a Geriatric University Outpatient Department

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05247814
Enrollment
2000
Registered
2022-02-21
Start date
2022-07-31
Completion date
2032-02-29
Last updated
2022-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug-Related Side Effects and Adverse Reactions, Pharmacogenetics, Pharmacogenomic Testing, Polypharmacy

Keywords

Geriatric Assessment, Medication Adherence, Aged, Aged, 80 and over, Medication therapy management, Pharmacists, Geriatricians, Clinical Pharmacology, Medication reconciliation, Hospital pharmacy services, Hospital outpatient clinics, nterdisciplinary Health Team

Brief summary

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

Detailed description

Adverse drug reactions are common in older patients and can lead to severe outcomes such as falls, hospitalizations and death. They are dose-dependent and may for example be caused by inappropriate dosing due to a reduced kidney function. Also, the use of potentially inappropriate medications in older patients can result in a negative benefit-/ risk-ratio. Additionally, drug metabolism in older patients is altered due to a variety of reasons and pharmacogenetic variants of drug metabolizing enzymes can lead to a more than 10-fold interinidividual variation of drug clearance. The risk of the individual patient to experience an adverse drug reactions is determined by many reasons. Therefore, this study aims to identify patient risk profiles with regard to pharmacogenetics, drug interactions, impaired functional and cognitive status and individual drug metabolism. Participants for this study will be consecutively recruited from 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. Regardless of their participation in this study, patients in the outpatient clinic will perform several tests and questionnaires following the comprehensive geriatric assessment. The purpose of the cohort study is to document and evaluate routine health data collected in the outpatient clinic for polypharmacy in geriatric patients (laboratory tests as well as a comprehensive medication history with therapy recommendations issued by a subsequent pharmaceutical council for both the patients and the primary care physicians). Procedures conducted specifically for this study are a long-term capture and detailed history of all suspected adverse drug reactions, examining the fear of falling (FES-I questionnaire) and blood sampling for exploratory pharmacogenomic analyses (on cohort level, not patient diagnostics). Aim of the long-term cohort of geriatric patients with polypharmacy is to identify risk profiles for adverse drug reactions that are specific for the population of older individuals.

Interventions

GENETICPharmacogenomic testing of a panel of important pharmacogenes to detect genetic variants and evaluate the association between genetically predicted and measured drug metabolism

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

OTHERAdverse Drug Reaction detection

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

OTHERFalls Efficacy Scale International (FES-I)

The FES-I wil be obtained to estimate fear of falling

Sponsors

B. Braun Foundation
CollaboratorOTHER
RWTH Aachen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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) * Written informed consent of the patient or the legal representative

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Identification of vulnerability profiles of adverse drug reactionsFebruary 2022 - February 2032To 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).

Contacts

Primary ContactMathias Freitag
mfreitag@ukaachen.de+492417501116
Backup ContactJulia C. Stingl, MD, ScD
jstingl@ukaachen.de+492418089130

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026