NCT05247814

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
70mo left

Started Jul 2022

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Jul 2022Feb 2032

First Submitted

Initial submission to the registry

February 9, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2032

Last Updated

June 23, 2022

Status Verified

June 1, 2022

Enrollment Period

9.6 years

First QC Date

February 9, 2022

Last Update Submit

June 17, 2022

Conditions

PolypharmacyPharmacogeneticsPharmacogenomic TestingDrug-Related Side Effects and Adverse Reactions

Keywords

Geriatric AssessmentMedication AdherenceAgedAged, 80 and overMedication therapy managementPharmacistsGeriatriciansClinical PharmacologyMedication reconciliationHospital pharmacy servicesHospital outpatient clinicsnterdisciplinary Health Team

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patients admitted to interdisciplinary polypharmacy consultation service

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

Genetic: Pharmacogenomic testing of a panel of important pharmacogenes to detect genetic variants and evaluate the association between genetically predicted and measured drug metabolismOther: Adverse Drug Reaction detectionOther: Falls Efficacy Scale International (FES-I)

Interventions

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

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

Patients admitted to interdisciplinary polypharmacy consultation service
Adverse Drug Reaction detectionOTHER

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

Patients admitted to interdisciplinary polypharmacy consultation service
Falls Efficacy Scale International (FES-I)OTHER

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

Patients admitted to interdisciplinary polypharmacy consultation service

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

DNA will be isolated from patients' blood samples. Patients will then be genotyped for relevant pharmacogenes focusing on drug metabolizing enzymes CYP2D6, 2C9, and 2C19 and other genes of clinical relevance

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsMedication Adherence

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Julia C. Stingl, MD, ScD

    Institute of Clinical Pharmacology, University Hospital RWTH Aachen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathias Freitag

CONTACT

+492417501116mfreitag@ukaachen.de

Julia C. Stingl, MD, ScD

CONTACT

+492418089130jstingl@ukaachen.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.-Prof. Dr. med.

Study Record Dates

First Submitted

February 9, 2022

First Posted

February 21, 2022

Study Start

July 1, 2022

Primary Completion (Estimated)

February 1, 2032

Study Completion (Estimated)

February 1, 2032

Last Updated

June 23, 2022

Record last verified: 2022-06