Quality Of Life and compliance after changing immunosuppression regimens
| ISRCTN | ISRCTN24752762 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24752762 |
| Protocol serial number | S-309/2010 |
| Sponsor | University Hospital Heidelberg (Germany) |
| Funder | Astellas Pharma GmbH, Munich, (Germany) |
- Submission date
- 27/02/2011
- Registration date
- 15/04/2011
- Last edited
- 18/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Helge Bruns
Scientific
Scientific
Department of General and Transplantation Surgery
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
| helge.bruns@med.uni-heidelberg.de |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective single-centre observational study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Quality Of Life and compliance after changing immunosuppression regimens: A prospective, single-centre, observational study |
| Study acronym | QOL-LTPL |
| Study objectives | Quality of life and compliance is considered to be a parameter as important as postoperative outcome in modern surgery. Retard formulations have an impact on compliance and quality of life and may lead to improved adherence to therapy. Currently, immunosuppressive regimens after liver transplantation are often changed to retard formulations of immunosuppressive medication. Our hypothesis is that both quality of life and compliance improve in these patients. To test our hypothesis, we will prospectively measure quality of life and compliance with standardised questionnaires when immunosuppressive regimens are changed to retard formulations and after three months in patients after liver transplantation. |
| Ethics approval(s) | Clinical Ethics Committee, Faculty of Medicine, Heidelberg University approved on 25th November 2010 (ref: S-309/2010) |
| Health condition(s) or problem(s) studied | Immunosuppressive regimens after liver transplantation |
| Intervention | In this observational study, compliance and quality of life are monitored in patients whose basic immunosuppressive regimen is changed to a once daily formulation using standardised questionnaires |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Quality of life as measured with the SF-36 health questionnaire |
| Key secondary outcome measure(s) |
Compliance as measured with the BAASIS interview |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. More than or equal to 12 months after liver transplantation 2. Aged more than or equal to 18 years 3. Change in immunosuppressive regimen to a retard formulation |
| Key exclusion criteria | 1. Intellectual or language barriers in understanding and answering the questionnaires 2. Patients admitted to the hospital |
| Date of first enrolment | 01/01/2011 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
Department of General and Transplantation Surgery
Heidelberg
69120
Germany
69120
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
