Trials / Completed
CompletedNCT03623217
Quality of Life Questionnaire Validation for Patients With Changed Tacrolimus Dosing After Kidney Transplantation
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 56 (actual)
- Sponsor
- Astellas Pharma Korea, Inc. · Industry
- Sex
- All
- Age
- 19 Years – 69 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Qualitative interviews with participants | For the development and validation of a questionnaire. |
Timeline
- Start date
- 2015-02-24
- Primary completion
- 2017-10-17
- Completion
- 2017-10-17
- First posted
- 2018-08-09
- Last updated
- 2024-10-21
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03623217. Inclusion in this directory is not an endorsement.