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

NCT03623217 | Completed

• 1 other identifier: ADV-KT-14-01
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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).

Conditions

Kidney Transplantation

Keywords

Behavioral; Questionnaire development; Questionnaire; Interview with patients; Observational; Tacrolimus; Patient reported outcome tool; Validation; Kidney transplantation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Kidney transplant participants receiving tacrolimus

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

Interventions

Qualitative interviews with participants BEHAVIORAL

For the development and validation of a questionnaire.

Kidney transplant participants receiving tacrolimus

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who underwent kidney transplantation

You may qualify if:

• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• Astellas Pharma Korea, Inc.: lead

Study Sites (1)

Site 1

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Behavior

Study Officials

• Astellas Pharma Korea, Inc.

  Astellas Pharma Korea, Inc.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 9, 2018
• Study Start: February 24, 2015
• Primary Completion: October 17, 2017
• Study Completion: October 17, 2017
• Last Updated: October 21, 2024

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)