Information-Assisted Intervention for Potential Living Kidney Donors

The Effectiveness of an Information-Assisted Intervention for Potential Living Kidney Donors

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.

Study Overview

• Status: Recruiting
• Conditions: Transplant Donation
• Intervention / Treatment: Other: Information-Assisted 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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ching-Hui Chien, PhD; Phone Number: 3103 +886-2-28227101; Email: chinghui@ntunhs.edu.tw

Study Locations

• Taiwan
  • Taoyuan District, Taiwan, 333
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: Kuanlin Liu; Phone Number: +886-2-24313131; Email: kuanlin@cgmh.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Information-Assisted group

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Thinking Scale	The Chinese version of the Positive Thinking Scale will be employed to assess participants' optimism and goal orientation. The 18-item instrument has a total score range of 18-80, where higher scores indicate greater personal satisfaction and goal pursuit.	Baseline (T0, prior to intervention), 4 weeks (T1) and 8 weeks (T2) after Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family Resilience Scale	The Short Form of the Chinese Family Resilience Assessment Scale (FRAS) will be used to measure family resilience among potential donors. Each of the 32 items is rated on a 4-point Likert scale (1 = strongly disagree, 4 = strongly agree), producing total scores from 32 to 128. Higher scores reflect greater family resilience.	Baseline (T0, prior to intervention)
Evaluation of the Information-Assisted Program	A five-item self-developed questionnaire will be used to evaluate participants' acceptance and satisfaction with the intervention. Scores range from 0-100, with higher values indicating stronger satisfaction and agreement that the intervention was beneficial and appropriate for future potential donors.	4 weeks (T1) after Baseline
Demographic and Clinical Characteristics-Age	Actual age (years)	Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Sex	Male / Female	Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Marital Status	Single, Married, Divorced, Separated, Widowed, Cohabiting	Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Education	None, Elementary, Junior High, Senior High, College/University, Graduate/Doctorate, Other	Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Religion	None, Taoism, Buddhism, Catholicism, Christianity, I-Kuan Tao, Other	Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Occupation	None, Physically demanding, Mentally demanding, Both, Neither, Retired, Other	Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Relationship to Recipient	Spouse, Sibling, Parent-child, Relative, Other	Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Perceived Health Status	One item; Score range 0-100; higher = better health perception	Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Chronic Diseases	None, Diabetes, Hypertension, Heart disease, Asthma, Bronchitis, Other	Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Serum Creatinine (mg/dL)	Higher values indicate poorer renal function	Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-24-h Creatinine Clearance (mL/min)	Higher values indicate better renal function	Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Estimated GFR (mL/min/1.73m²)	Higher values indicate better renal function	Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Urine Protein	None, Present, Other	Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Serum Creatinine-Body Weight (kilograms)	Measured in kilograms	Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Height (centimeters)	Measured in centimeters	Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Information Source	None, Physician, Transplant Coordinator, Nurse/NP, Other	Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Decision Status	No, Considering, Yes	Baseline (T0, prior to intervention), 4 weeks (T1) and 8 weeks (T2) after Baseline
Demographic and Clinical Characteristics-Family Support	Supportive, Neutral, Not supportive	Baseline (T0, prior to intervention)
Recipient-Related Clinical Data-Dialysis Treatment	Yes / No (Hemodialysis or Peritoneal Dialysis)	Baseline (T0, prior to intervention)
Recipient-Related Clinical Data-Serum Creatinine (mg/dL)	Higher values indicate poorer renal function	Baseline (T0, prior to intervention)

Collaborators and Investigators

• Sponsor: National Taipei University of Nursing and Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: knowledge; decision self-efficacy; decisional conflict; Potential Living Kidney Donors
• Other Study ID Numbers: 202102488B0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data supporting this study's findings are available from the corresponding author upon reasonable request. The data are not publicly available due to the consideration of ethics, the researchers shall maintain the privacy of the participants, and research data should be used only for academic articles.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No