Quality Of Life and compliance after changing immunosuppression regimens

ISRCTN	ISRCTN24752762
DOI	https://doi.org/10.1186/ISRCTN24752762
Secondary identifying numbers	S-309/2010

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

Department of General and Transplantation Surgery
Im Neuenheimer Feld 110
Heidelberg
69120
Germany

Email	helge.bruns@med.uni-heidelberg.de

Study information

Study design	Prospective single-centre observational study
Primary study design	Observational
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	Quality of life as measured with the SF-36 health questionnaire
Secondary outcome measures	Compliance as measured with the BAASIS interview
Overall study start date	01/01/2011
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

Sponsor information

University Hospital Heidelberg (Germany)
University/education

Im Neuenheimer Feld 672
Heidelberg
69120
Germany

"ROR"	https://ror.org/013czdx64

Funders

Funder type

University/education

Astellas Pharma GmbH, Munich, (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