Information-Assisted Intervention for Potential Living Kidney Donors

NCT07243717 | Recruiting

• 1 other identifier: 202102488B0
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Transplant Donation

Keywords

Potential Living Kidney Donors; knowledge; decision self-efficacy; decisional conflict

Outcome Measures

Primary Outcomes (3)

• Decision Self-Efficacy Scale

  The Chinese version of the Decision Self-Efficacy Scale from the Ottawa Hospital Research Institute will be used. This 11-item scale measures individuals' confidence in making informed decisions. Each item is scored from 0-4, with total scores converted to a range of 0-100. Higher scores reflect stronger decision self-efficacy.

  Baseline (T0, prior to intervention), 4 weeks (T1) and 8 weeks (T2) after Baseline

• Decisional Conflict Scale

  The study will employ the Chinese version of the Decisional Conflict Scale developed by the Ottawa Hospital Research Institute. The 16-item scale uses a 0-4 rating system (0 = yes, 4 = no). Total scores are calculated as (sum of items ÷ number of items) × 25, yielding a range of 0-100. Higher scores indicate greater decisional conflict.

  Baseline (T0, prior to intervention), 4 weeks (T1) and 8 weeks (T2) after Baseline

• Knowledge Test on Living Kidney Donation

  A 31-item self-developed test will assess participants' knowledge regarding living kidney donation, including anatomy, legal regulations, donor eligibility, medical coverage, surgical risks, postoperative complications, and post-surgical care. Each question has three options: True, False, and Unclear. Correct answers receive 1 point, while incorrect or unclear answers receive 0 points. Higher total scores indicate better knowledge.

  Baseline (T0, prior to intervention), 4 weeks (T1) and 8 weeks (T2) after Baseline

Secondary Outcomes (1)

• Positive Thinking Scale

  Baseline (T0, prior to intervention), 4 weeks (T1) and 8 weeks (T2) after Baseline

Other Outcomes (22)

• Family Resilience Scale

  Baseline (T0, prior to intervention)

• Evaluation of the Information-Assisted Program

  4 weeks (T1) after Baseline

• Demographic and Clinical Characteristics-Age

  Baseline (T0, prior to intervention)

Study Arms (1)

Information-Assisted group

EXPERIMENTAL

Other: Information-Assisted Intervention

Interventions

Information-Assisted Intervention 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.

Information-Assisted group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

Central Study Contacts

Ching-Hui Chien, PhD

CONTACT

+886-2-28227101; chinghui@ntunhs.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, PhD, Professor

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: March 27, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)