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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01398488
Other study ID # V 2.0 16/03/2011
Secondary ID
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


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
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