Patient Education After Lung Transplantation Via Tablet Computers Versus Conventional Education

Hannover Medical School (MHH)

Status and phase: Completed; Phase 2

Conditions: Lung Transplantation

Treatments: Behavioral: Patient education

Study type: Interventional

Funder types: Other

Identifiers

NCT01398488

V 2.0 16/03/2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Conventional Patient education

Active Comparator group

Description:

Conventional Patient education by health care professionals.

Treatment:

Behavioral: Patient education

Patient education via Tablet computer

Experimental group

Description:

Patient education after lung transplantation via Tablet computers. An electronic patient questionnaire via tablet computer will be collected in addition.

Treatment:

Behavioral: Patient education