Information-Assisted Intervention for Potential Living Kidney Donors

NCT ID: NCT07243717

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-07-31

Brief Summary

This study aims to evaluate the effectiveness of an information-assisted intervention in enhancing knowledge, decision self-efficacy, and reducing decisional conflict among potential living kidney donors. Using a one-group pretest-posttest design, participants will be recruited from the urology and kidney transplant outpatient clinics of two hospitals in northern Taiwan. After providing informed consent and completing a baseline questionnaire (T0), participants will receive a four-week information-assisted intervention in addition to routine care, with follow-up assessments at 4 weeks (T1) and 8 weeks (T2). Data will be collected using structured questionnaires assessing decisional conflict, decision self-efficacy, knowledge, positive thinking, family resilience, and satisfaction with the intervention.

Detailed Description

The purpose of this study is to examine the effectiveness of an information-assisted intervention in improving knowledge, decision self-efficacy, and decisional conflict among potential living kidney donors.

A one-group pretest-posttest design will be adopted. During the study period, participants will be recruited through convenience sampling from the urology and kidney transplant outpatient clinics of two hospitals in northern Taiwan. Eligible potential donors who have completed medical examinations and return for follow-up visits to review tissue matching and laboratory test results will be invited to participate in the study (experimental group). After providing informed consent, participants will complete a baseline questionnaire (T0) in a private setting.

Participants will then receive the information-assisted intervention, followed by the first posttest (T1) at 4 weeks and the second posttest (T2) at 8 weeks after T0. In addition to routine care, the experimental group will receive a four-week information-assisted intervention.

Data will be collected using structured questionnaires, including the Decisional Conflict Scale, Decision Self-Efficacy Scale, Knowledge Test on Living Kidney Donation, Demographic and Clinical Characteristics Questionnaire, Positive Thinking Scale, Evaluation Form for the Information-Assisted Program, and the Family Resilience Scale.

Conditions

Transplant Donation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Information-Assisted group

Group Type: EXPERIMENTAL

Information-Assisted Intervention

Intervention Type: OTHER

The intervention content was formulated based on previous Delphi study results and a comprehensive literature review. To facilitate comprehension, the educational materials were presented using illustrations, mind maps, tables, and concise text in an educational manual. Participants may record questions arising during their learning process, which will be discussed and clarified during consultation sessions by members of the transplant team, including physicians, social workers, and transplant coordinators.

Interventions

Information-Assisted Intervention

The intervention content was formulated based on previous Delphi study results and a comprehensive literature review. To facilitate comprehension, the educational materials were presented using illustrations, mind maps, tables, and concise text in an educational manual. Participants may record questions arising during their learning process, which will be discussed and clarified during consultation sessions by members of the transplant team, including physicians, social workers, and transplant coordinators.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Willing to undergo evaluation for living kidney donation
• Owns a smartphone or tablet with internet access
• Able and willing to participate in the study and provide written informed consent

Exclusion Criteria

• Deemed unsuitable for kidney donation after evaluation by a transplant specialist

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Ching-Hui Chien

RN, PhD, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

Central Contacts

Ching-Hui Chien, PhD

Role: CONTACT

chinghui@ntunhs.edu.tw

+886-2-28227101 ext. 3103

Facility Contacts

Kuanlin Liu

Role: primary

kuanlin@cgmh.org.tw

+886-2-24313131

Other Identifiers

202102488B0

Identifier Type: -

Identifier Source: org_study_id