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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Kidney Transplantation
- Sponsor
- Astellas Pharma Korea, Inc.
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Health Related Quality of Life(HRQoL) measured by the newly developed and validated Kidney Transplantation and Quality of Life(KTQoL) Questionnaire
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Health Related Quality of Life(HRQoL) measured by the newly developed and validated Kidney Transplantation and Quality of Life(KTQoL) Questionnaire
Time Frame: Up to a maximum of 32 months
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.