Patient Education After Lung Transplantation Via Tablet Computers Versus Conventional Education

Study Overview
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Brief Summary
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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
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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.

Official Title
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Patient Education After Lung Transplantation Via Tablet Computers Versus Conventional Education - a Randomized Open Controlled Trial

Conditions
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Lung Transplantation

Intervention / Treatment
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* Behavioral: Patient education


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Patient education<br>Conventional Patient education by health care professionals. | Behavioral: Patient education<br>* Patient education by health care professional compared to education via tablet PC<br>|
| Experimental: Patient education via Tablet computer<br>Patient education after lung transplantation via Tablet computers. An electronic patient questionnaire via tablet computer will be collected in addition. | Behavioral: Patient education<br>* Patient education by health care professional compared to education via tablet PC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcineurin trough levels | Improvement of percentage of calcineurin inhibitor trough levels (Delta %) in target range 6 months after patient education compared to 6 months before patient education | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcineurin trough levels variability | Trough level variability 6 months after patient education compared to 6 months before patient education | 6 month | 
| Interval Adherence | interval adherence (number of measurements vs. recommended measurements) 6 months after patient education compared to 6 months before patient education | 6 month | 
| Trough level interval | Interval of trough level measurement variability 6 months after patient education compared to 6 months before patient education | 6 month | 
| Total time of education | Total time of education | 6 month | 
| Total time of answering questionnaire | Total time of answering questionnaire | 6 month | 
| Knowledge Improvement | Improvement of patient knowledge on immunosuppressive after patient education | 6 month | 
| Self rated adherence | Self rated adherence to immunosuppressive medication (BAASIS scale) | 6 month | 
| Adherence | Therapy adherence 6 months after patient education compared to 6 months before patient education | 6 month | 
| Glomerular filtration rate | Glomerular filtration rate 6 months after patient education compared to baseline (CKD-EPI) | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trough levels, Education, Adherence