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Empowering Patients to Improve Safety in Polymedication

Empowering Patients to Improve Safety in Polymedication - EmPaSafe

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57343
Enrollment
30
Registered
2024-08-19
Start date
2025-08-28
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

concurrent medication use, multiple drug use concurrent medication use, multiple drug use

Interventions

The MMC that provides patient centred information on drug-drug interactions and pharmacogenetics affecting personal polytherapy. The MMC will show a selection of high quality publicly available info

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: • Polypharmacy defined as the use of 5 or more drugs • Start usage of at least one of 27 index drugs, for at least 7 con-secutive days.  • Subject must be >= 18 years old • Subject is able and willing to take part and be followed-up for at least 12  weeks • Subject is able to provide DNA via blood, saliva or a buccal swab • Subject has signed informed consent

Exclusion criteria

Exclusion criteria: Pregnancy or lactating Life expectancy estimated to be less than three months by treating clinical team Unable to consent to the studyUnwilling to take partNo fixed addressPrevious (direct-to-consumer or clinical) pharmacogenetic testing for a gene relevant to the index drug.No current general practitioner Duration of treatment: Duration of index drug treatment is planned to be less than seven consecutive days.  Impaired organ function:Existing impaired hepatic or renal function for which dose adjustment or alternative drug selection are already part of routine care. This does not apply to drugs specifically given to manage liver/renal impairment or transplantation.Estimated glomerular filtration rate (MDRD) of less than 15 ml/min per 1.73 m² in a subject with a functioning graft.Patients with advanced liver failure (Child-Pugh class C).Investigator judgement: The subject is, in the opinion of the Investigator, not suitable to participate in the study.

Design outcomes

Primary

MeasureTime frame
The primary outcome is the sense of empowerment and health literacy for participants before and after use of the MMC.

Secondary

MeasureTime frame
Secondary outcomes include an evaluation of the drug-drug-gene interactions and adverse drug events in the study populations compared to matched historical controls.

Countries

Germany, Greece, Netherlands, Slovenia

Contacts

Public ContactJ.J. Swen

Leids Universitair Medisch Centrum

j.j.swen@lumc.nl071 526 2790

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)