Lung Transplantation
Conditions
Keywords
Trough levels, Education, Adherence
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPatient education
Patient education by health care professional compared to education via tablet PC
Sponsors
Hannover Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients at least 6 months after lung transplantation (single, double or combined) * Informed consent * At least 10 trough levels analyzed in MHH reference lab in last 6 months * \< 50% of calcineurin inhibitor trough levels in target range in last 6 months in outpatient clinic
Exclusion criteria
* Hospitalization during last 3 months * BOS stage 3 (FEV1 \< 50% baseline) * End stage kidney disease (GFR \<15 ml/min/1.73 m2 or renal replacement therapy) * Oxygen requirement at rest * Steroid pulse therapy (\>500 mg methylprednisolone per day) during the last 4 weeks * Illiteracy * Need for isolation (Colonization with multi. or pan resistant organisms, e.g. MRSA, B. cenocepacia) * limited German language skills or other reasons which might impair patient communication or computer handling
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calcineurin trough levels | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interval Adherence | 6 month | interval adherence (number of measurements vs. recommended measurements) 6 months after patient education compared to 6 months before patient education |
| Trough level interval | 6 month | Interval of trough level measurement variability 6 months after patient education compared to 6 months before patient education |
| Total time of education | 6 month | Total time of education |
| Total time of answering questionnaire | 6 month | Total time of answering questionnaire |
| Calcineurin trough levels variability | 6 month | Trough level variability 6 months after patient education compared to 6 months before patient education |
| Self rated adherence | 6 month | Self rated adherence to immunosuppressive medication (BAASIS scale) |
| Adherence | 6 month | Therapy adherence 6 months after patient education compared to 6 months before patient education |
| Glomerular filtration rate | 6 month | Glomerular filtration rate 6 months after patient education compared to baseline (CKD-EPI) |
| Knowledge Improvement | 6 month | Improvement of patient knowledge on immunosuppressive after patient education |
Countries
Germany
Outcome results
None listed