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Impact of a pharmaceutical care program on liver transplant patients? compliance with immunosuppressive medication - A prospective, randomized, controlled trial using electronic monitoring

Impact of a pharmaceutical care program on liver transplant patients? compliance with immunosuppressive medication - A prospective, randomized, controlled trial using electronic monitoring

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN83224156
Enrollment
50
Registered
2007-10-30
Start date
2003-09-01
Completion date
Unknown
Last updated
2021-06-21

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

Conditions

Liver transplants Injury, Occupational Diseases, Poisoning Liver transplants

Interventions

In addition to routine clinical care, patients in the intervention group receive pharmaceutical care services provided by a dedicated hospital pharmacist. The Pharmaceutical Care program usually start

Sponsors

University Hospital Mainz, Pharmacy Department (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Written informed consent 2. Age 18 years or older 3. First organ transplant 4. Follow-up care at the University Hospital Mainz for the first year after transplantation 5. Administration of oral immunosuppressive therapy as capsule or tablet 6. Literacy (German language)

Exclusion criteria

Exclusion criteria: Patients who are not willing to use the Medication Event Monitoring Systems® (MEMS®)

Design outcomes

Primary

MeasureTime frame
Compliance with immunosuppressive medication measured by MEMS® for 12 months, starting at discharge.

Secondary

MeasureTime frame
1. Compliance with immunosuppressive medication measured by the following: 1.1. Pill counts, performed at each ambulatory visit 1.2. Blood levels, performed at each ambulatory visit 1.3. Questionnaires at baseline, 6 and 12 months 2. Quality of life, measured by the 36-item Short Form health survey (SF-36) at discharge, 6 and 12 months after discharge 3. Patients' knowledge regarding drug therapy, assessed by interviews using a standardized questionnaire at 2 weeks after discharge, at first ambulatory visit and 12 months after discharge 4. Patients' satisfaction with the pharmaceutical care provided, assessed by a questionnaire developed for this trial at discharge

Countries

Germany

Outcome results

None listed

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