An interventional study of Information-Assisted Intervention in Transplant Donation, sponsored by National Taipei University of Nursing and Health Sciences. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by National Taipei University of Nursing and Health Sciences · Not applicable, Interventional, and Supportive care
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.
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.
National Taipei University of Nursing and Health Sciences is the lead sponsor of 124 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Deemed unsuitable for kidney donation after evaluation by a transplant specialist
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (T0, prior to intervention), 4 weeks (T1) and 8 weeks (T2) after Baseline
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.
Time frame: Baseline (T0, prior to intervention), 4 weeks (T1) and 8 weeks (T2) after Baseline
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.
Time frame: 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.
Time frame: 4 weeks (T1) after Baseline
Demographic and Clinical Characteristics-Age
Actual age (years)
Time frame: Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Sex
Male / Female
Time frame: Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Marital Status
Single, Married, Divorced, Separated, Widowed, Cohabiting
Time frame: Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Education
None, Elementary, Junior High, Senior High, College/University, Graduate/Doctorate, Other
Time frame: Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Religion
None, Taoism, Buddhism, Catholicism, Christianity, I-Kuan Tao, Other
Time frame: Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Occupation
None, Physically demanding, Mentally demanding, Both, Neither, Retired, Other
Time frame: Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Relationship to Recipient
Spouse, Sibling, Parent-child, Relative, Other
Time frame: Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Perceived Health Status
One item; Score range 0-100; higher = better health perception
Time frame: Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Chronic Diseases
None, Diabetes, Hypertension, Heart disease, Asthma, Bronchitis, Other
Time frame: Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Serum Creatinine (mg/dL)
Higher values indicate poorer renal function
Time frame: Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-24-h Creatinine Clearance (mL/min)
Higher values indicate better renal function
Time frame: Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Estimated GFR (mL/min/1.73m²)
Higher values indicate better renal function
Time frame: Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Urine Protein
None, Present, Other
Time frame: Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Serum Creatinine-Body Weight (kilograms)
Measured in kilograms
Time frame: Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Height (centimeters)
Measured in centimeters
Time frame: Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Information Source
None, Physician, Transplant Coordinator, Nurse/NP, Other
Time frame: Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Decision Status
No, Considering, Yes
Time frame: Baseline (T0, prior to intervention), 4 weeks (T1) and 8 weeks (T2) after Baseline
Demographic and Clinical Characteristics-Family Support
Supportive, Neutral, Not supportive
Time frame: Baseline (T0, prior to intervention)
Recipient-Related Clinical Data-Dialysis Treatment
Yes / No (Hemodialysis or Peritoneal Dialysis)
Time frame: Baseline (T0, prior to intervention)
Recipient-Related Clinical Data-Serum Creatinine (mg/dL)
Higher values indicate poorer renal function
Time frame: Baseline (T0, prior to intervention)
Plan to share: No — 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.
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