Patient Education After Lung Transplantation Via Tablet Computers Versus Conventional Education

NCT ID: NCT01398488

Last Updated: 2013-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-05-31

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.

Conditions

Lung Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Conventional Patient education

Conventional Patient education by health care professionals.

Group Type: ACTIVE_COMPARATOR

Patient education

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Patient education

Intervention Type: BEHAVIORAL

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

Interventions

Patient education

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hannover Medical School

OTHER

Sponsor Role: lead

Responsible Party

Thomas Fuehner

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jens T Gottlieb, MD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

Hanover Medical School

Hanover, Lower Saxony, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 36094829 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24608864 (View on PubMed)

Other Identifiers

V 2.0 16/03/2011

Identifier Type: -

Identifier Source: org_study_id