Patient Education After Lung Transplantation Via Tablet Computers Versus Conventional Education

Lung Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01398488
• Other study ID #: V 2.0 16/03/2011
• Status: Completed
• Phase: Phase 2
• First received: July 5, 2011
• Last updated: June 5, 2013
• Start date: July 2011
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lung Transplantation

Intervention

Behavioral:
• Patient education
Patient education by health care professional compared to education via tablet PC

Locations

Country	Name	City	State
Germany	Hanover Medical School	Hanover	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Calcineurin trough levels variability	Trough level variability 6 months after patient education compared to 6 months before patient education	6 month	No
Secondary	Interval Adherence	interval adherence (number of measurements vs. recommended measurements) 6 months after patient education compared to 6 months before patient education	6 month	No
Secondary	Trough level interval	Interval of trough level measurement variability 6 months after patient education compared to 6 months before patient education	6 month	No
Secondary	Total time of education	Total time of education	6 month	No
Secondary	Total time of answering questionnaire	Total time of answering questionnaire	6 month	No
Secondary	Knowledge Improvement	Improvement of patient knowledge on immunosuppressive after patient education	6 month	No
Secondary	Self rated adherence	Self rated adherence to immunosuppressive medication (BAASIS scale)	6 month	No
Secondary	Adherence	Therapy adherence 6 months after patient education compared to 6 months before patient education	6 month	No
Secondary	Glomerular filtration rate	Glomerular filtration rate 6 months after patient education compared to baseline (CKD-EPI)	6 month	No