Impact of a pharmaceutical care program on liver transplant patients compliance with immunosuppressive medication - A prospective, randomized, controlled trial using electronic monitoring
| ISRCTN | ISRCTN83224156 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83224156 |
| Secondary identifying numbers | N/A |
- Submission date
- 24/09/2007
- Registration date
- 30/10/2007
- Last edited
- 10/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Anja Klein
Scientific
Scientific
Pharmacy Department
University Hospital Mainz
Langenbeckstr. 1
Mainz
55131
Germany
Study information
| Study design | Prospective, randomized, controlled, single-center study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | Impact of a pharmaceutical care program on liver transplant patients compliance with immunosuppressive medication - A prospective, randomized, controlled trial using electronic monitoring |
| Study objectives | Pharmaceutical care provided to liver transplant patients increases compliance with the immunosuppressive medication. |
| Ethics approval(s) | Approved by the Ethics Committee of the Medical Association of Rheinland-Pfalz (Landesaerztekammer Rheinland-Pfalz) on 23/06/2003. (ref: 873.166.03[3828]) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2003 |
| Completion date | 30/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key 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) |
| Key exclusion criteria | Patients who are not willing to use the Medication Event Monitoring Systems® (MEMS®) |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 30/03/2005 |
Locations
Countries of recruitment
- Germany
Study participating centre
Pharmacy Department
Mainz
55131
Germany
55131
Germany
Sponsor information
University Hospital Mainz, Pharmacy Department (Germany)
University/education
University/education
Langenbeckstr.1
Mainz
55131
Germany
| Website | http://www.uni-mainz.de/FB/Medizin/Apotheke/homepage/index.html |
|---|---|
"ROR" |
https://ror.org/00q1fsf04 |
Funders
Funder type
University/education
University Hospital Mainz (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 27/03/2009 | 10/06/2021 | Yes | No |
Editorial Notes
10/06/2021: Publication reference added.
