Condition category
Injury, Occupational Diseases, Poisoning
Date applied
24/09/2007
Date assigned
30/10/2007
Last edited
30/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anja Klein

ORCID ID

Contact details

Pharmacy Department
University Hospital Mainz
Langenbeckstr. 1
Mainz
55131
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Pharmaceutical care provided to liver transplant patients increases compliance with the immunosuppressive medication.

Ethics approval

Approved by the Ethics Committee of the Medical Association of Rheinland-Pfalz (Landesaerztekammer Rheinland-Pfalz) on 23/06/2003. (ref: 873.166.03[3828])

Study design

Prospective, randomized, controlled, single-center study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Liver transplants

Intervention

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 starts about 1 week before discharge from the transplant surgery unit. The hospital pharmacist meets the patient 3 to 4 times and educates him on different issues regarding immunosuppressive medication, e.g. action of the drugs, side effects, interactions, vital signs, laboratory data and discharge medication. On the day of discharge, the hospital pharmacist hands over and explains written information including a discharge medication plan, information regarding the immunosuppressive therapy, and a diary for documenting vital signs and laboratory data.

During the first year after transplantation, meetings with the care taking hospital pharmacist take place on a regular basis. The patient meets the pharmacist at least once every three months and maximum once per month. During these meetings the pharmacist discusses with the patient changes in medication, laboratory values and drug-related problems. Preferably, family members are involved. In addition, the hospital pharmacist reviews the patients' drug therapy, in order to assess and minimize drug related problems and simplify drug therapy.

Patients allocated to the control group receive the same medical care as the intervention group, except the direct pharmaceutical care described above.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/09/2003

Overall trial end date

30/03/2005

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

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

Recruitment start date

01/09/2003

Recruitment end date

30/03/2005

Locations

Countries of recruitment

Germany

Trial participating centre

Pharmacy Department
Mainz
55131
Germany

Sponsor information

Organisation

University Hospital Mainz, Pharmacy Department (Germany)

Sponsor details

Langenbeckstr.1
Mainz
55131
Germany

Sponsor type

University/education

Website

http://www.uni-mainz.de/FB/Medizin/Apotheke/homepage/index.html

Funders

Funder type

University/education

Funder name

University Hospital Mainz (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes