Contact information
Type
Scientific
Primary contact
Dr Helge Bruns
ORCID ID
Contact details
Department of General and Transplantation Surgery
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
helge.bruns@med.uni-heidelberg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
S-309/2010
Study information
Scientific title
Quality Of Life and compliance after changing immunosuppression regimens: A prospective, single-centre, observational study
Acronym
QOL-LTPL
Study hypothesis
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
Clinical Ethics Committee, Faculty of Medicine, Heidelberg University approved on 25th November 2010 (ref: S-309/2010)
Study design
Prospective single-centre observational study
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
Quality of life as measured with the SF-36 health questionnaire
Secondary outcome measures
Compliance as measured with the BAASIS interview
Overall trial start date
01/01/2011
Overall trial end date
31/12/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Intellectual or language barriers in understanding and answering the questionnaires
2. Patients admitted to the hospital
Recruitment start date
01/01/2011
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Germany
Trial participating centre
Department of General and Transplantation Surgery
Heidelberg
69120
Germany
Funders
Funder type
University/education
Funder name
Astellas Pharma GmbH, Munich, (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
Basic results (scientific)
Publication list