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Patients who receive a kidney transplant have to learn in 10-14 days which anti-rejection medication to take, how to take it ,... This learning process is attended by the nurses of the ward. This study wants to measure the degree of medication knowledge, health literacy and medication adherence of those patients.
Patients who receive a kidney transplant arrive at the abdominal transplantation surgery ward after surgery. Within 10-14 days they learn which anti-rejection medication they have to take, how they have to take it and to what they have to pay attention. This learning process is attended by the nurses of the ward.
It is already known that a bad medication adherence is related to a higher rejection rate and mortality of patients who receive a kidney transplant. Bad medication knowledge and low health literacy are correlated with a bad medication adherence. Data about the level of health literacy of the Belgian population (and certainly of patients who just received a kidney transplant) are scarce.
The main purpose of this study is to have an idea of the extent of medication knowledge, heath literacy and adherence in patients who received a renal transplant.
Therefore, a prospective cohort study will be performed. Adult patients admitted for a renal transplantation, will be included after obtainment of informed consent. The patients will be followed for 2 years. On predefined time points, the participants will have to fill in questionnaires and tests: on discharge 2 tests that measure health literacy, the "Basel Assessment of Adherence to Immunosuppressive Medications Scale" (BAASIS), the medication knowledge test and a questionnaire about demographic factors. At 1 month post-transplantation the BAASIS test and medication knowledge test, 3 months post-transplantation the 2 tests assessing health literacy, the BAASIS test and medication knowledge test and finally after 1 and 2 years all the tests (4 in total) and questionnaire assessing demographic factors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Admitted for renal transplantation | Other | Patients who are hospitalised on the abdominal transplantation surgery ward at the University Hospitals of Leuven (UZLeuven) and undergo a kidney transplantation during this hospitalisation. Intervention: taking questionnaires and tests at predefined timepoints:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taking questionnaires and tests | Other | At predefined timepoints:
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| Measure | Description | Time Frame |
|---|---|---|
| Degree of medication knowledge pre-and post kidney transplantation as measured by the self-edited medication knowledge test | Measurement: quantitative score | Up to 36 months |
| Degree of health literacy pre- and post kidney transplantation as measured by the NVS-D and FCCHL test | Measurement: NVS-D = quantitative score (max = 6 points) with 3 groups: low health literacy = 0-1; intermediate health literacy = 2-3; high health literacy = 4-6. The FCCHL contains 3 subitems (functional, communicative and critical health literacy) Each subitem contains 4 questions. Each question is rated on a 4-point scale, ranging from 1 to 4 (4 indicating high health literacy). The scores for the items in a scale are summed and divided by the number of items in the scale to give a scale score (theoretical range 1-4). | Up to 36 months |
| Degree of medication adherence pre- and post kidney transplantation assessed by the BAASIS test | Measurement: BAASIS = 4 questions assessing adherence. If the patient answers 'no' on at least 1 question, the patient is categorized as 'non-adherent'. | Up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Type of evolution in the degree of medication knowledge (assessed by self-edited test, see above), health literacy (assessed by NVS-D and FCCHL, see above) and/or medication adherence (assessed by BAASIS, see above). | Is their a positive or negative evolution in medication knowledge, health literacy and/or medication adherence at discharge-1month-3 months-1 year-2 years after kidney transplantation? |
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Inclusion Criteria: patients who are admitted at the abdominal transplantation surgery ward and just underwent a kidney transplantation
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nadine Adams | UZ Leuven | Principal Investigator |
| Barbara Deleenheer | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24003247 | Background | Hartono C, Muthukumar T, Suthanthiran M. Immunosuppressive drug therapy. Cold Spring Harb Perspect Med. 2013 Sep 1;3(9):a015487. doi: 10.1101/cshperspect.a015487. | |
| 19843035 | Background | Pinsky BW, Takemoto SK, Lentine KL, Burroughs TE, Schnitzler MA, Salvalaggio PR. Transplant outcomes and economic costs associated with patient noncompliance to immunosuppression. Am J Transplant. 2009 Nov;9(11):2597-606. doi: 10.1111/j.1600-6143.2009.02798.x. |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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|
| Up to 36 months |
| Correlation between degree of medication knowledge, degree of health literacy and/or degree of medication adherence | Up to 36 months |
| Correlation between evolution of medication knowledge, evolution of health literacy and/or evolution of medication adherence | Up to 36 months |
| Defining risk factors (assessed by the demographic questionnaire) related to the degree of medication knowledge, health literacy and/or medication adherence | Up to 36 months |
| Defining risk factors (assessed by the demographic questionnaire) related to the evolution of medication knowledge, health literacy and/or medication adherence | Up to 36 months |
| Correlation between the degree of medication knowledge, health literacy and/or medication adherence, and outcome parameters (trend of serum creatinine, result of biopsy of kidney transplant, trend and variation of tacrolimus' trough level) | Up to 36 months |
| Correlation between the evolution of medication knowledge, health literacy and/or medication adherence, and the outcome parameters (trend of serum creatinine, result of biopsy of kidney transplant, trend and variation of tacrolimus' trough level). | Up to 36 months |
| 15307839 | Background | Vlaminck H, Maes B, Evers G, Verbeke G, Lerut E, Van Damme B, Vanrenterghem Y. Prospective study on late consequences of subclinical non-compliance with immunosuppressive therapy in renal transplant patients. Am J Transplant. 2004 Sep;4(9):1509-13. doi: 10.1111/j.1600-6143.2004.00537.x. |
| 23042431 | Background | Ponticelli C, Graziani G. Education and counseling of renal transplant recipients. J Nephrol. 2012 Nov-Dec;25(6):879-89. doi: 10.5301/jn.5000227. |
| 15364635 | Background | LaFleur J, Oderda GM. Methods to measure patient compliance with medication regimens. J Pain Palliat Care Pharmacother. 2004;18(3):81-7. |
| 20531073 | Background | Dobbels F, Berben L, De Geest S, Drent G, Lennerling A, Whittaker C, Kugler C; Transplant360 Task Force. The psychometric properties and practicability of self-report instruments to identify medication nonadherence in adult transplant patients: a systematic review. Transplantation. 2010 Jul 27;90(2):205-19. doi: 10.1097/TP.0b013e3181e346cd. |
| 7871562 | Background | De Geest S, Borgermans L, Gemoets H, Abraham I, Vlaminck H, Evers G, Vanrenterghem Y. Incidence, determinants, and consequences of subclinical noncompliance with immunosuppressive therapy in renal transplant recipients. Transplantation. 1995 Feb 15;59(3):340-7. |
| 24619949 | Background | Zhang NJ, Terry A, McHorney CA. Impact of health literacy on medication adherence: a systematic review and meta-analysis. Ann Pharmacother. 2014 Jun;48(6):741-51. doi: 10.1177/1060028014526562. Epub 2014 Mar 11. |
| 22276600 | Background | Sorensen K, Van den Broucke S, Fullam J, Doyle G, Pelikan J, Slonska Z, Brand H; (HLS-EU) Consortium Health Literacy Project European. Health literacy and public health: a systematic review and integration of definitions and models. BMC Public Health. 2012 Jan 25;12:80. doi: 10.1186/1471-2458-12-80. |
| 25224314 | Background | Fransen MP, Leenaars KE, Rowlands G, Weiss BD, Maat HP, Essink-Bot ML. International application of health literacy measures: adaptation and validation of the newest vital sign in The Netherlands. Patient Educ Couns. 2014 Dec;97(3):403-9. doi: 10.1016/j.pec.2014.08.017. Epub 2014 Sep 3. |
| 22878030 | Background | van der Vaart R, Drossaert CH, Taal E, ten Klooster PM, Hilderink-Koertshuis RT, Klaase JM, van de Laar MA. Validation of the Dutch functional, communicative and critical health literacy scales. Patient Educ Couns. 2012 Oct;89(1):82-8. doi: 10.1016/j.pec.2012.07.014. Epub 2012 Aug 9. |
| 25455794 | Background | Heijmans M, Waverijn G, Rademakers J, van der Vaart R, Rijken M. Functional, communicative and critical health literacy of chronic disease patients and their importance for self-management. Patient Educ Couns. 2015 Jan;98(1):41-8. doi: 10.1016/j.pec.2014.10.006. Epub 2014 Oct 16. |
| D001519 | Behavior |