Trial record 4 of 2193 for:    Kidney Transplantation

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2015 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT02606175
First received: October 27, 2015
Last updated: November 12, 2015
Last verified: October 2015
  Purpose
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 Intervention
Adherence to Medication Regime
Other: Taking questionnaires and tests

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Medication Knowledge, Medication Adherence and Health Literacy in Patients Who Underwent a Kidney Transplantation.

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Degree of medication knowledge pre-and post kidney transplantation as measured by the self-edited medication knowledge test [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Measurement: quantitative score

  • Degree of health literacy pre- and post kidney transplantation as measured by the NVS-D and FCCHL test [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

    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).


  • Degree of medication adherence pre- and post kidney transplantation assessed by the BAASIS test [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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:
  • Type of evolution in the degree of medication knowledge (assessed by self-edited questionnaire, 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 12 months ] [ Designated as safety issue: No ]
    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?

  • Correlation between degree of medication knowledge, degree of health literacy and/or degree of medication adherence [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Correlation between evolution of medication knowledge, evolution of health literacy and/or evolution of medication adherence [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • 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 12 months ] [ Designated as safety issue: No ]
  • 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 12 months ] [ Designated as safety issue: No ]
  • 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 12 months ] [ Designated as safety issue: No ]
  • 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 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2015
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Recent kidney transplantation

Patients who are hospitalised on the abdominal transplantation surgery ward at the University Hospitals of Leuven (UZLeuven) and underwent a kidney transplantation during this hospitalisation.

Intervention: taking questionnaires and tests at predefined timepoints:

  • at discharge: NVS-D, FCCHL, BAASIS, medication knowledge questionnaire, demographic factors questionnaire
  • 1 month after kidney transplantation: BAASIS, medication knowledge questionnaire
  • 3 months after kidney transplantation: NVS-D, FCCHL, BAASIS, medication knowledge 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 questionnaire for medication adherence: BAASIS
  • 1 questionnaire about demographic factors (weight, income, sex, age, financial situation,...)
  • 1 questionnaire about medication knowledge
Kidney transplantation 1/2 years ago

Patients who come for a biopsy of the kidney and underwent a kidney transplantation 1 or 2 years ago.

Intervention: taking questionnaires and tests ( NVS-D, FCCHL, BAASIS, medication knowledge questionnaire, 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 questionnaire for medication adherence: BAASIS
  • 1 questionnaire about demographic factors (weight, income, sex, age, financial situation,...)
  • 1 questionnaire about medication knowledge

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, two type of patients will be included in the study (see 2 arms). The first arm will have to fill in the questionnaires and tests at multiple timepoints: all the questionnaires and tests 2 days before discharge, the "Basel Assessment of Adherence to Immunosuppressive Medications Scale" (BAASIS) and medication knowledge questionnaire 1 month after discharge and finally all the questionnaires (except demographic factors questionnaire) and tests 3 months after discharge. The second arm wil have to fill in all the questionnaires and tests at one moment (1 or 2 years after kidney transplantation).

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Arm 1: patients who are admitted at the abdominal transplantation surgery ward and just underwent a kidney transplantation
  • Arm 2: patients who come to the hospital for a renal biopsy 1 or 2 years after their kidney transplantation

Exclusion Criteria:

  • Patients who cannot sufficiently write, read or speak Dutch.
  • Patients who don't take care of their medication themselves.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02606175

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

Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Nadine Adams UZ Leuven
Principal Investigator: Barbara Deleenheer UZ Leuven
  More Information

Additional Information:
Publications:

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02606175     History of Changes
Other Study ID Numbers: s58561 
Study First Received: October 27, 2015
Last Updated: November 12, 2015
Health Authority: Belgium: Ethics Committee

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

ClinicalTrials.gov processed this record on August 25, 2016