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Adherence to Medication RegimeNCT02606175

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

A study testing Taking questionnaires and tests in people with Adherence to Medication Regime, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adherence to Medication Regime
What is being tested?
Taking questionnaires and tests
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBelgium
Study dates
Feb 2016to Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • University Hospitals Leuven

    Leuven, 3000

Other trials in Belgium

About this study

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.

Read the detailed description

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

Being tested
Taking questionnaires and tests
Keywords
health literacy, patient medication knowledge, kidney transplantation, medication adherence, kidney transplant, renal transplantation
Medical subject headings
Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Taking questionnaires and testsOther

    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
Study groups in NCT02606175
Study groupRoleWhat they receive
Admitted for renal transplantationOtherPatients 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
Receives: Other: Taking questionnaires and tests

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Degree of medication knowledge pre-and post kidney transplantation as measured by the self-edited medication knowledge test

    Measurement: quantitative score

    Measured: Up to 36 months

  2. 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).

    Measured: Up to 36 months

  3. 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'.

    Measured: Up to 36 months

Secondary outcomes (7)
  1. 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?

    Measured: Up to 36 months

  2. Correlation between degree of medication knowledge, degree of health literacy and/or degree of medication adherence

    Measured: Up to 36 months

  3. Correlation between evolution of medication knowledge, evolution of health literacy and/or evolution of medication adherence

    Measured: Up to 36 months

  4. Defining risk factors (assessed by the demographic questionnaire) related to the degree of medication knowledge, health literacy and/or medication adherence

    Measured: Up to 36 months

  5. Defining risk factors (assessed by the demographic questionnaire) related to the evolution of medication knowledge, health literacy and/or medication adherence

    Measured: Up to 36 months

  6. 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)

    Measured: Up to 36 months

  7. 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).

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2015 (estimated)
  2. Study startFeb 2016
  3. Primary completionFeb 2019
  4. Study completionNov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02606175
Sponsor's protocol ID
s58561
Status last verified
Oct 2018
First submitted
27 Oct 2015
Last updated
4 May 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 24003247
  • 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.

    PubMed 19843035
  • 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.

    PubMed 15307839
  • 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.

    PubMed 23042431
  • LaFleur J, Oderda GM. Methods to measure patient compliance with medication regimens. J Pain Palliat Care Pharmacother. 2004;18(3):81-7.

    PubMed 15364635
  • 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.

    PubMed 20531073
  • 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.

    PubMed 7871562
  • 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.

    PubMed 24619949
  • 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.

    PubMed 22276600
  • 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.

    PubMed 25224314
  • 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.

    PubMed 22878030
  • 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.

    PubMed 25455794

Questions about this trial

What is this clinical trial studying?

A study testing Taking questionnaires and tests in people with Adherence to Medication Regime, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Degree of medication knowledge pre-and post kidney transplantation as measured by the self-edited medication knowledge test (time frame: Up to 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02606175, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.

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