Condition category
Surgery
Date applied
27/02/2011
Date assigned
15/04/2011
Last edited
18/04/2011
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 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 measures

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

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

Sponsor information

Organisation

University Hospital Heidelberg (Germany)

Sponsor details

Im Neuenheimer Feld 672
Heidelberg
69120
Germany

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes