Patient Education After Lung Transplantation Via Tablet Computers Versus Conventional Education

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Transplantation
• Intervention / Treatment: Behavioral: Patient education

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Lower Saxony
    • Hanover, Lower Saxony, Germany, 30625
      • Hanover Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calcineurin trough levels variability	Trough level variability 6 months after patient education compared to 6 months before patient education	6 month
Interval Adherence	interval adherence (number of measurements vs. recommended measurements) 6 months after patient education compared to 6 months before patient education	6 month
Trough level interval	Interval of trough level measurement variability 6 months after patient education compared to 6 months before patient education	6 month
Total time of education	Total time of education	6 month
Total time of answering questionnaire	Total time of answering questionnaire	6 month
Knowledge Improvement	Improvement of patient knowledge on immunosuppressive after patient education	6 month
Self rated adherence	Self rated adherence to immunosuppressive medication (BAASIS scale)	6 month
Adherence	Therapy adherence 6 months after patient education compared to 6 months before patient education	6 month
Glomerular filtration rate	Glomerular filtration rate 6 months after patient education compared to baseline (CKD-EPI)	6 month

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Investigators: Principal Investigator: Jens T Gottlieb, MD, Hannover Medical School

Publications and helpful links

General Publications

• Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
• Suhling H, Rademacher J, Zinowsky I, Fuge J, Greer M, Warnecke G, Smits JM, Bertram A, Haverich A, Welte T, Gottlieb J. Conventional vs. tablet computer-based patient education following lung transplantation--a randomized controlled trial. PLoS One. 2014 Mar 7;9(6):e90828. doi: 10.1371/journal.pone.0090828. eCollection 2014.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: July 5, 2011
• First Submitted That Met QC Criteria: July 19, 2011
• First Posted (Estimate): July 20, 2011

Study Record Updates

• Last Update Posted (Estimate): June 6, 2013
• Last Update Submitted That Met QC Criteria: June 5, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Adherence; Education; Trough levels
• Other Study ID Numbers: V 2.0 16/03/2011