Patient Education After Lung Transplantation Via Tablet Computers Versus Conventional Education

Phase 2

Completed

• Conditions: Lung Transplantation
• Interventions: Behavioral: Patient education

• Registration Number: NCT01398488
• Lead Sponsor: Hannover Medical School

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-05
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-20
• Primary Completion: 2012-07
• Study Completion: 2013-05
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-05
• Last Update Posted: 2013-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Patient education	Patient education	Conventional Patient education by health care professionals.
Patient education via Tablet computer	Patient education	Patient education after lung transplantation via Tablet computers. An electronic patient questionnaire via tablet computer will be collected in addition.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Calcineurin trough levels variability	6 month	Trough level variability 6 months after patient education compared to 6 months before patient education
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
Knowledge Improvement	6 month	Improvement of patient knowledge on immunosuppressive after 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)

Trial Locations

Locations (1)

Hanover Medical School; 🇩🇪 Hanover, Lower Saxony, Germany