Clinical trial NCT01398488: Patient Education After Lung Transplantation Via Tablet Computers Versus Conventional Education
Official title: Patient Education After Lung Transplantation Via Tablet Computers Versus Conventional Education - a Randomized Open Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Transplantation
Keywords: Trough levels
Education
Adherence
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2011-07-20
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Calcineurin trough levels
timeFrame: 6 month
Secondary outcomes:
measure: Calcineurin trough levels variability
timeFrame: 6 month
measure: Interval Adherence
timeFrame: 6 month
measure: Trough level interval
timeFrame: 6 month
measure: Total time of education
timeFrame: 6 month
measure: Total time of answering questionnaire
timeFrame: 6 month
measure: Knowledge Improvement
timeFrame: 6 month
measure: Self rated adherence
timeFrame: 6 month
measure: Adherence
timeFrame: 6 month
measure: Glomerular filtration rate
timeFrame: 6 month
Other outcomes:
Locations:
city: Hanover
country: Germany
facility: Hanover Medical School
state: Lower Saxony
Study officials:
affiliation: Hannover Medical School
name: Jens T Gottlieb, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.