Hanover Medical School
Hanover, Lower Saxony, 30625, Germany
NCT Number: NCT01398488
Experimental intervention:
Patient education after lung transplantation via Tablet computers. An electronic patient questionnaire via tablet computer will be collected in addition.
Control intervention:
Conventional Patient education by health care professionals. A paper-based patient questionnaire will be provided.
Looking for future studies?
Notify MeAll sexes
Interventional
Phase 2
Hanover, Lower Saxony, 30625, Germany
Noncompliance with immunosuppressive medications after organ transplantation is thought to be a leading cause of allograft rejection, graft loss, and death. Immunosuppressant medy to prevent graft rejection after lung transplantation.
Reported non-compliance rates with calcineurin inhibitors are ranging between 13 and 22 % after lung transplantation. Incidence of non-compliance increases over time after transplantation. Increased health care costs, decreased quality of life, and organ failure (incl. the need for re-do transplantation) are possible consequences of immunosuppressant noncompliance. Therefore, medication compliance defined as the extent to which a patient's medication taking behaviour coincides with the prescribed regimen, is a critical issue in transplantation. Repeated patient education is one option to overcome non-adherence and immunosuppressive medication non-compliance.
Immunosuppressive therapy is monitored by measurement of drug levels. Fluctuating drug levels increase the risk for rejection and drug toxicities. In addition, frequent dose adjustments, case management and frequent monitoring of drug levels are cost-intensive.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient education by health care professional compared to education via tablet PC
Time frame: 6 month
Improvement of percentage of calcineurin inhibitor trough levels (Delta %) in target range 6 months after patient education compared to 6 months before patient education
Time frame: 6 month
Trough level variability 6 months after patient education compared to 6 months before patient education
Time frame: 6 month
interval adherence (number of measurements vs. recommended measurements) 6 months after patient education compared to 6 months before patient education
Time frame: 6 month
Interval of trough level measurement variability 6 months after patient education compared to 6 months before patient education
Time frame: 6 month
Total time of education
Time frame: 6 month
Total time of answering questionnaire
Time frame: 6 month
Improvement of patient knowledge on immunosuppressive after patient education
Time frame: 6 month
Self rated adherence to immunosuppressive medication (BAASIS scale)
Time frame: 6 month
Therapy adherence 6 months after patient education compared to 6 months before patient education
Time frame: 6 month
Glomerular filtration rate 6 months after patient education compared to baseline (CKD-EPI)
Hannover Medical School
Other
Patient Education After Lung Transplantation Via Tablet Computers Versus Conventional Education - a Randomized Open Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07716878
Bacterial Infections and Mycoses, Hematopoietic Stem Cell Transplantation (HSCT)
Guangzhou, Guangdong, China
View Trial DetailsNCT01294020
Heart Transplantation, Intestine Transplantation
Brussels, Belgium
View Trial DetailsNCT07660991
Lun Transplant Candidates, Lung Transplantation
Istanbul, Kartal, Turkey (Türkiye)
View Trial DetailsNCT07525440
Lung Transplantation
Guangzhou, China
View Trial Details