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Randomized intervention trial to investigate the influence of clinical pharmaceutical care and use of the national standardized medication plan on drug adherence in liver-transplanted patients

Randomized intervention trial to investigate the influence of clinical pharmaceutical care and use of the national standardized medication plan on drug adherence in liver-transplanted patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00028018
Enrollment
46
Registered
2022-02-04
Start date
2018-11-29
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Adherence in liver transplant patients.

Interventions

Group 1: Intervention group: care by physician and pharmacist. Patients receive five counseling sessions with the pharmacist and a nationally standardized medication plan at four time points. All pat

Sponsors

Apotheke Universitätsmedizin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Willingness to participate in the study: written declaration of consent for participation and data collection Completion of the 18th year of life Liver transplanted patients on the ward for general, visceral, transplantation surgery, who recently became recipients of a liver transplant and receive Prograf® (Tacrolimus) as an immunosuppressive agent Patients who, after their discharge, make use of the follow-up visits in the transplant outpatient clinic of the Mainz University Medical Center Patients who understand German

Exclusion criteria

Exclusion criteria: Patients with retransplantation Unwillingness to participate in the study Lack of capacity to understand or to give consent

Design outcomes

Primary

MeasureTime frame
The primary outcome measure of the study is dosing adherence (DA), which is determined using the Medication Event Monitoring System (MEMSTM). Dosing adherence indicates the percentage of days on which the drug was taken according to the treatment plan.

Secondary

MeasureTime frame
The following secondary outcome measures are determined: Taking-Adherence (TA): percent of days the drug was taken correctly. Timing Adherence (TiA): Percent of days on which the prescribed doses were taken at the correct time (± 2 hours). Drug Holidays (DH): no drug intake for more than 48 hours. Drug adherence by questionnaire Drug adherence by rating scale Drug adherence by blood level Drug adherence by Pharmacy Refill Patient knowledge Patient satisfaction with medication information

Countries

Germany

Contacts

Public ContactIrene Krämer

Apotheke Universitätsmedizin

alina.walter@unimedizin-mainz.de06131174573

Outcome results

None listed

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