Patient Education After Lung Transplantation Via Tablet Computers Versus Conventional Education - a Randomized Open Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Hannover Medical School
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Calcineurin trough levels
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Conventional Patient education
Conventional Patient education by health care professionals.
Intervention: Patient education (Behavioral)
Patient education via Tablet computer
Patient education after lung transplantation via Tablet computers. An electronic patient questionnaire via tablet computer will be collected in addition.
Intervention: Patient education (Behavioral)
Outcomes
Primary Outcomes
Calcineurin trough levels
Time Frame: 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 Outcomes
- Calcineurin trough levels variability(6 month)
- Interval Adherence(6 month)
- Trough level interval(6 month)
- Total time of education(6 month)
- Total time of answering questionnaire(6 month)
- Knowledge Improvement(6 month)
- Self rated adherence(6 month)
- Adherence(6 month)
- Glomerular filtration rate(6 month)
Investigators
Thomas Fuehner
MD
Hannover Medical School