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Patient Education After Lung Transplantation Via Tablet Computers Versus Conventional Education

This study is currently recruiting participants.
Verified July 2011 by Hannover Medical School
Sponsor:
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01398488
First received: July 5, 2011
Last updated: July 25, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Lung Transplantation
 Behavioral: Patient education
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Patient Education After Lung Transplantation Via Tablet Computers Versus Conventional Education - a Randomized Open Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Calcineurin trough levels [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Calcineurin trough levels variability [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Trough level variability 6 months after patient education compared to 6 months before patient education

  • Interval Adherence [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    interval adherence (number of measurements vs. recommended measurements) 6 months after patient education compared to 6 months before patient education

  • Trough level interval [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Interval of trough level measurement variability 6 months after patient education compared to 6 months before patient education

  • Total time of education [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Total time of education

  • Total time of answering questionnaire [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Total time of answering questionnaire

  • Knowledge Improvement [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Improvement of patient knowledge on immunosuppressive after patient education

  • Self rated adherence [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Self rated adherence to immunosuppressive medication (BAASIS scale)

  • Adherence [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Therapy adherence 6 months after patient education compared to 6 months before patient education

  • Glomerular filtration rate [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Glomerular filtration rate 6 months after patient education compared to baseline (CKD-EPI)


Estimated Enrollment: 62
Study Start Date: July 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional Patient education
Conventional Patient education by health care professionals.
 Behavioral: Patient education
Patient education by health care professional compared to education via tablet PC
Experimental: 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.
 Behavioral: Patient education
Patient education by health care professional compared to education via tablet PC

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398488

Contacts
Contact: Jens Gottlieb, MD 0049511/532 ext 4681 gottlieb.jens@mh-hannover.de
Contact: Jan Fuge 0049511/532 ext 9863 fuge.jan@mh-hannover.de

Locations
Germany
Hanover Medical School Recruiting
Hanover, Lower Saxony, Germany, 30625
Contact: Jan Fuge     0049511-5329863        
Contact: Imke Zinowsky     0049-5115329863        
Principal Investigator: Jens Gottlieb, MD            
Sub-Investigator: Hendrik Suhling, MD            
Sponsors and Collaborators
Hannover Medical School
Investigators
Principal Investigator: Jens T Gottlieb, MD Hannover Medical School
  More Information

No publications provided

Responsible Party: PD Dr. med. Jens Gottlieb, Hanover Medical School
ClinicalTrials.gov Identifier: NCT01398488     History of Changes
Other Study ID Numbers: V 2.0 16/03/2011
Study First Received: July 5, 2011
Last Updated: July 25, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Hannover Medical School:
Trough levels
Education
Adherence

ClinicalTrials.gov processed this record on May 23, 2013