Medication Knowledge, Medication Adherence and Health Literacy in Patients Who Underwent a Kidney Transplantation.
NCT ID: NCT02606175
Last Updated: 2021-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2016-02-29
2019-11-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Admitted for renal transplantation
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:
* at discharge: NVS-D, FCCHL, BAASIS, medication knowledge test, demographic factors questionnaire
* 1 month after kidney transplantation: BAASIS, medication knowledge test
* 3 months after kidney transplantation: NVS-D, FCCHL, BAASIS, medication knowledge test
* 1 year after kidney transplantation: NVS-D, FCCHL, BAASIS, medication knowledge test, demographic factors questionnaire
* 2 years after kidney transplantation: NVS-D, FCCHL, BAASIS, medication knowledge test, demographic factors questionnaire
Taking questionnaires and tests
At predefined timepoints:
* 2 tests for health literacy: New Vital Sign-Dutch version (NVS-D) and Functional, Communicative and Critical Health Literacy (FCCHL)
* 1 test for medication adherence: BAASIS
* 1 questionnaire about demographic factors (weight, income, sex, age, financial situation,...)
* 1 test about medication knowledge
Interventions
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Taking questionnaires and tests
At predefined timepoints:
* 2 tests for health literacy: New Vital Sign-Dutch version (NVS-D) and Functional, Communicative and Critical Health Literacy (FCCHL)
* 1 test for medication adherence: BAASIS
* 1 questionnaire about demographic factors (weight, income, sex, age, financial situation,...)
* 1 test about medication knowledge
Eligibility Criteria
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Exclusion Criteria
* Patients who don't take care of their medication themselves.
18 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Nadine Adams
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven
Barbara Deleenheer
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven
Locations
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University Hospitals Leuven
Leuven, , Belgium
Countries
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References
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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.
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.
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.
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.
LaFleur J, Oderda GM. Methods to measure patient compliance with medication regimens. J Pain Palliat Care Pharmacother. 2004;18(3):81-7.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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s58561
Identifier Type: -
Identifier Source: org_study_id
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