Individual Risk Profiles for Adverse Drug Reactions in Geriatric Patients

Polypharmacy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05247814
• Other study ID #: 21-216
• Status: Not yet recruiting
• Start date: July 2022
• Est. completion date: February 2032

Study information

• Verified date: June 2022
• Source: RWTH Aachen University
• Contact: Mathias Freitag
• Phone: +492417501116
• Email: mfreitag[@]ukaachen.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: February 2032
• Est. primary completion date: February 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• Pharmacogenetics
• Polypharmacy

Intervention

Genetic:
• Pharmacogenomic 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

Other:
• Adverse 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
• Falls Efficacy Scale International (FES-I)
The FES-I wil be obtained to estimate fear of falling

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
RWTH Aachen University	B. Braun-Stiftung

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	February 2022 - February 2032