Medication Knowledge, Medication Adherence and Health Literacy in Patients Who Underwent a Kidney Transplantation.

NCT02606175 | Completed

• 1 other identifier: s58561
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adherence to Medication Regime

Keywords

health literacy; patient medication knowledge; kidney transplantation; medication adherence; kidney transplant; renal transplantation

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (7)

• 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).

  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

Study Arms (1)

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: * 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

Other: Taking questionnaires and tests

Interventions

Taking questionnaires and tests OTHER

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

Admitted for renal transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients who cannot sufficiently write, read or speak Dutch.
• Patients who don't take care of their medication themselves.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Related Publications (12)

• 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.

  PMID: 24003247 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.

  PMID: 19843035 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.

  PMID: 15307839 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.

  PMID: 23042431 BACKGROUND

• LaFleur J, Oderda GM. Methods to measure patient compliance with medication regimens. J Pain Palliat Care Pharmacother. 2004;18(3):81-7.

  PMID: 15364635 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.

  PMID: 20531073 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.

  PMID: 7871562 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.

  PMID: 24619949 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.

  PMID: 22276600 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.

  PMID: 25224314 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.

  PMID: 22878030 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.

  PMID: 25455794 BACKGROUND

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Nadine Adams

  UZ Leuven

  PRINCIPAL INVESTIGATOR

• Barbara Deleenheer

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: November 17, 2015
• Study Start: February 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: November 1, 2019
• Last Updated: May 4, 2021

Record last verified: 2018-10

Locations

BE (1)