Quality of Life Questionnaire Validation for Patients With Changed Tacrolimus Dosing After Kidney Transplantation

Study Overview
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Brief Summary
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The purpose of this study is to develop and validate a questionnaire to assess the quality of life when the recipients of kidney transplantation switched their medication from tacrolimus twice daily (BID regimen) to Advagraf (once daily (QD) regimen of modified release tacrolimus).

Detailed Description
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This study will develop and validate a questionnaire to assess the health-related quality of life when switching from tacrolimus twice daily (b.i.d) regimen to once daily (q.d) regimen after kidney transplantation. In-depth interviews are conducted to develop questionnaire items, and the interviewees are as follows: participants who have received tacrolimus b.i.d for a minimum of 6 months to a maximum of 12 months, and who are within 1 month of switching to Advagraf (q.d regimen of modified release tacrolimus). The time required for the in-depth interview is approximately 30 minutes to one hour. After questionnaire items are developed, survey participants for validation are as follows: the first survey is conducted on participants who have received tacrolimus b.i.d for a minimum of 6 months to a maximum of 12 months during the period. The second survey is conducted within one month after switching to Advagraf (q.d regimen of modified release tacrolimus). At the validation stage, the survey using the developed questionnaire is conducted twice, once during the b.i.d. regimen and once after switching to the q.d. regimen.

Official Title
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Development and Validation of the Questionnaire in Assessing the Health-related Quality of Life of Patients Who Switch From b.i.d to q.d of Tacrolimus After Kidney Transplantation

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Behavioral: Qualitative interviews with participants


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Selection criteria for in-depth interview subjects: One male or female aged 30 or over but below 40 years old. One male or female aged 60 or over but below 70 years old. One male or female with an occupation. One male or female without an occupation. Two subjects, depending on the number of medications (more or less medications) that the subject is taking. Participation available Period: subjects who have received tacrolimus twice daily (b.i.d) for a minimum of 6 months to a maximum of 12 months after surgery and who are within 1 month of switching to Advagraf (once daily (q.d) regimen of modified release tacrolimus). Subjects who understood the purpose and risks of the questionnaire development and who were well-acquainted with the contents and submitted the written consent to participate in the interview for the questionnaire development. Selection criteria for validation stage subjects: Males and females aged 19 to 65 years old. Participation Available Period: the first survey is conducted on the subjects who have received tacrolimus twice daily (b.i.d) for a minimum of 6 months to a maximum of 12 months during the period. The second survey is conducted within one month after switching to Advagraf (once daily (q.d) regimen of modified release tacrolimus). Subjects who understood the purpose and risks of the questionnaire development and who were well-acquainted with the contents and submitted the written consent to participate in the interview for the questionnaire development. Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kidney transplant participants receiving tacrolimus<br>Transplant participants who have received tacrolimus twice daily for a minimum of 6 months to a maximum of 12 months after the surgery, and who are within 1 month of switching to the once daily regimen of modified release tacrolimus. | Behavioral: Qualitative interviews with participants<br>* For the development and validation of a questionnaire.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life(HRQoL) measured by the newly developed and validated Kidney Transplantation and Quality of Life(KTQoL) Questionnaire | KTQoL is a transplantation-specific questionnaire to assess 'General QoL' for transplant participants after surgery and 'Specific QoL' for transplant participants after conversion from twice-daily (BID) to once-daily (QD) tacrolimus. 'General QoL' represents how good the participant's HRQoL is after a transplant surgery and 'Specific QoL' shows how good the participant's health is after conversion of medication from BID to QD. The KTQoL questionnaire consists of 24 questions, 17 for 'General Health' and 7 for 'Specific Health'. The total 'General QoL' scores range from 0-58 and it has sub-scales scores of global scale (range of 0-4), worry (range of 0-16), symptom (range of 0-28) and everyday life (range of 0-10). The total 'Specific QoL' scores range from 0-22 with no sub-scales. Higher values represent a better outcome. | Up to a maximum of 32 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioral, Questionnaire development, Questionnaire, Interview with patients, Observational, Tacrolimus, Patient reported outcome tool, Validation, Kidney transplantation