Kidney Transplantation Clinical Trial
Official title:
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
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).
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.
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