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OpenTrials
Completed

NCT Number: NCT01398488

Patient Education After Lung Transplantation Via Tablet Computers Versus Conventional Education

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.

Completed

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hanover Medical School

Hanover, Lower Saxony, 30625, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient education

Behavioral

Patient education by health care professional compared to education via tablet PC

Primary outcomes

  1. 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

  1. Calcineurin trough levels variability

    Time frame: 6 month

    Trough level variability 6 months after patient education compared to 6 months before patient education

  2. Interval Adherence

    Time frame: 6 month

    interval adherence (number of measurements vs. recommended measurements) 6 months after patient education compared to 6 months before patient education

  3. Trough level interval

    Time frame: 6 month

    Interval of trough level measurement variability 6 months after patient education compared to 6 months before patient education

  4. Total time of education

    Time frame: 6 month

    Total time of education

  5. Total time of answering questionnaire

    Time frame: 6 month

    Total time of answering questionnaire

  6. Knowledge Improvement

    Time frame: 6 month

    Improvement of patient knowledge on immunosuppressive after patient education

  7. Self rated adherence

    Time frame: 6 month

    Self rated adherence to immunosuppressive medication (BAASIS scale)

  8. Adherence

    Time frame: 6 month

    Therapy adherence 6 months after patient education compared to 6 months before patient education

  9. Glomerular filtration rate

    Time frame: 6 month

    Glomerular filtration rate 6 months after patient education compared to baseline (CKD-EPI)

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jul 20, 2011
Registry last updated
Jun 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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