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Trial record 11 of 315 for:    Recruiting, Not yet recruiting, Available Studies | kidney transplantation

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

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ClinicalTrials.gov Identifier: NCT02606175
Recruitment Status : Recruiting
First Posted : November 17, 2015
Last Update Posted : November 23, 2016
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment Phase
Adherence to Medication Regime Other: Taking questionnaires and tests Not Applicable

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Medication Knowledge, Medication Adherence and Health Literacy in Patients Who Underwent a Kidney Transplantation.
Study Start Date : February 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Other: 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




Primary Outcome Measures :
  1. Degree of medication knowledge pre-and post kidney transplantation as measured by the self-edited medication knowledge test [ Time Frame: Up to 36 months ]
    Measurement: quantitative score

  2. Degree of health literacy pre- and post kidney transplantation as measured by the NVS-D and FCCHL test [ Time Frame: Up to 36 months ]

    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).


  3. Degree of medication adherence pre- and post kidney transplantation assessed by the BAASIS test [ Time Frame: Up to 36 months ]
    Measurement: BAASIS = 4 questions assessing adherence. If the patient answers 'no' on at least 1 question, the patient is categorized as 'non-adherent'.


Secondary Outcome Measures :
  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). [ Time Frame: Up to 36 months ]
    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?

  2. Correlation between degree of medication knowledge, degree of health literacy and/or degree of medication adherence [ Time Frame: Up to 36 months ]
  3. Correlation between evolution of medication knowledge, evolution of health literacy and/or evolution of medication adherence [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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). [ Time Frame: Up to 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: patients who are admitted at the abdominal transplantation surgery ward and just underwent a kidney transplantation

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02606175


Contacts
Contact: Nadine Adams nadine.adams@uzleuven.be
Contact: Barbara Deleenheer barbara.deleenheer@uzleuven.be

Locations
Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Nadine Adams       nadine.adams@uzleuven.be   
Contact: Barbara Deleenheer, PharmD       barbara.deleenheer@uzleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Nadine Adams UZ Leuven
Principal Investigator: Barbara Deleenheer UZ Leuven

Additional Information:
Publications:

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02606175     History of Changes
Other Study ID Numbers: s58561
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Universitaire Ziekenhuizen Leuven:
health literacy
patient medication knowledge
kidney transplantation
medication adherence
kidney transplant
renal transplantation