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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Patient education | Active Comparator | Conventional Patient education by health care professionals. |
|
| Patient education via Tablet computer | Experimental | Patient education after lung transplantation via Tablet computers. An electronic patient questionnaire via tablet computer will be collected in addition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient education | Behavioral | Patient education by health care professional compared to education via tablet PC |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens T Gottlieb, MD | Hannover Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanover Medical School | Hanover | Lower Saxony | 30625 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36094829 | Derived | 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. | |
| 24608864 | Derived | 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. |
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| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| 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 |