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Study to improve drug safety

Study to improve drug safety - K304

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00003305
Enrollment
3000
Registered
2011-11-16
Start date
2011-09-28
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

knowledge deficits and limited medication management skills

Interventions

Group 1: Part 1 of the study: Patients of the intervention group will receive a booklet with common informations for a safe drug usage previous to the first home visit. Part 2 of the study: Patients w

Sponsors

Medizinische Klinik, Abteilung Klinische Pharmakologie und Pharmakoepidemiologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
64 Years to 86 Years

Inclusion criteria

Inclusion criteria: participation on the Esther-Study - written agreement to the home visit and the intervention - medical treatment with at least one drug (participants who don't take any medicine will receive a brochure but won't be considered by the data analysis Additional inclusion criteria for part 2 of the study: existence of deficits

Exclusion criteria

Exclusion criteria: severe cognitive disturbances - less german language ability Further exclusion criteria for part 2 of the study: existence of serious application deficits. Those patients will receive an instruction in any case.

Design outcomes

Primary

MeasureTime frame
Part 1 of the study: Comparison of the basic knowledge concerning safe drug usage in the intervention group (whom the brochure was sent prior to the first home visit) with the control group (whom the brochure was given during the home visit). Measuring time: first home visit, second home visit (approx. 4 weeks after first home visit), telephone inteview (6 months after first home visit) Measuring procedure: Participants will be questioned with an electronic tool implemented for the collection of ESTHER-data. Subsequently a sum score will be calculated. Part 2 of the study: Intervention group: Comparison of the deficits in drug application during the first home visit (before training by the study physician) with the deficits in drug application during the second home visit (after obtaining an instruction by the study physicians). Control group: Comparison of the deficits in drug application during the first home visit with the deficits in drug application during the second home visit (no instruction by the study physician in spite of deficits in drug application). Measuring time: First home visit (Assessment of the deficits with a points-based system in the tool) + second home visit. Measuring procedure: Participants will be questioned with an electronic tool implemented for the collection of ESTHER-data. The correct drug application will therefore be demonstrated and/or explained by the participant. Subsequently a sum score will be calculated.

Secondary

MeasureTime frame
- assessment of the sustainability of part 1 and part 2 of the study based on telephone interviews 6 months after the first home visit. - use of devices in drug application (e.g. devices to facilitate eye drop application or tablet splitting, spacer) during first and second home visit. - use of medication schedules during first home visit and during telephone interview - changes in medication due to problems, which occured in part 2 of the study (e.g. problems concerning tablet splitting --> switch to another dosage; switch from two therapeutic agents to one combined preparation in order to reduce the complexity of the drug therapy) during second home visit and telephone interview. - participants' evaluation concerning the intervention (effect of the brochure, effect of the instruction conducted by the study physicians) during second home visit and telephone interview - the effect of interventions in relevant subgroups (inhalers, bisphosphonates, eye drops, splitting techniques of tablets, insulinpens) during second home visit and telephone interview.

Countries

Germany

Contacts

Public ContactTatjana Demtschuk Herr Gregor Thal

Epidemiologisches Krebsregister Saarland

esther@gbe-ekr.saarland.de+49(0)681 501-2387, +49(0)681 501-6192

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026