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NCT Number: NCT07243717

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.

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Key information

Conditions

Transplant Donation

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Decision Self-Efficacy Scale

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

    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.

  2. Decisional Conflict Scale

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

    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.

  3. Knowledge Test on Living Kidney Donation

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

    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.

Secondary outcomes

  1. Positive Thinking Scale

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

    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.

Other outcomes

  1. Family Resilience Scale

    Time frame: Baseline (T0, prior to intervention)

    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.

  2. Evaluation of the Information-Assisted Program

    Time frame: 4 weeks (T1) after Baseline

    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.

  3. Demographic and Clinical Characteristics-Age

    Time frame: Baseline (T0, prior to intervention)

    Actual age (years)

  4. Demographic and Clinical Characteristics-Sex

    Time frame: Baseline (T0, prior to intervention)

    Male / Female

  5. Demographic and Clinical Characteristics-Marital Status

    Time frame: Baseline (T0, prior to intervention)

    Single, Married, Divorced, Separated, Widowed, Cohabiting

  6. Demographic and Clinical Characteristics-Education

    Time frame: Baseline (T0, prior to intervention)

    None, Elementary, Junior High, Senior High, College/University, Graduate/Doctorate, Other

  7. Demographic and Clinical Characteristics-Religion

    Time frame: Baseline (T0, prior to intervention)

    None, Taoism, Buddhism, Catholicism, Christianity, I-Kuan Tao, Other

  8. Demographic and Clinical Characteristics-Occupation

    Time frame: Baseline (T0, prior to intervention)

    None, Physically demanding, Mentally demanding, Both, Neither, Retired, Other

  9. Demographic and Clinical Characteristics-Relationship to Recipient

    Time frame: Baseline (T0, prior to intervention)

    Spouse, Sibling, Parent-child, Relative, Other

  10. Demographic and Clinical Characteristics-Perceived Health Status

    Time frame: Baseline (T0, prior to intervention)

    One item; Score range 0-100; higher = better health perception

  11. Demographic and Clinical Characteristics-Chronic Diseases

    Time frame: Baseline (T0, prior to intervention)

    None, Diabetes, Hypertension, Heart disease, Asthma, Bronchitis, Other

  12. Demographic and Clinical Characteristics-Serum Creatinine (mg/dL)

    Time frame: Baseline (T0, prior to intervention)

    Higher values indicate poorer renal function

  13. Demographic and Clinical Characteristics-24-h Creatinine Clearance (mL/min)

    Time frame: Baseline (T0, prior to intervention)

    Higher values indicate better renal function

  14. Demographic and Clinical Characteristics-Estimated GFR (mL/min/1.73m²)

    Time frame: Baseline (T0, prior to intervention)

    Higher values indicate better renal function

  15. Demographic and Clinical Characteristics-Urine Protein

    Time frame: Baseline (T0, prior to intervention)

    None, Present, Other

  16. Demographic and Clinical Characteristics-Serum Creatinine-Body Weight (kilograms)

    Time frame: Baseline (T0, prior to intervention)

    Measured in kilograms

  17. Demographic and Clinical Characteristics-Height (centimeters)

    Time frame: Baseline (T0, prior to intervention)

    Measured in centimeters

  18. Demographic and Clinical Characteristics-Information Source

    Time frame: Baseline (T0, prior to intervention)

    None, Physician, Transplant Coordinator, Nurse/NP, Other

  19. Demographic and Clinical Characteristics-Decision Status

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

    No, Considering, Yes

  20. Demographic and Clinical Characteristics-Family Support

    Time frame: Baseline (T0, prior to intervention)

    Supportive, Neutral, Not supportive

  21. Recipient-Related Clinical Data-Dialysis Treatment

    Time frame: Baseline (T0, prior to intervention)

    Yes / No (Hemodialysis or Peritoneal Dialysis)

  22. Recipient-Related Clinical Data-Serum Creatinine (mg/dL)

    Time frame: Baseline (T0, prior to intervention)

    Higher values indicate poorer renal function

Study contacts

Contact information is provided by the study sponsor or research team.

Ching-Hui Chien, PhD

CONTACT

[email protected]

+886-2-28227101 ext. 3103

Sponsors and collaborators

Lead sponsor

National Taipei University of Nursing and Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 24, 2025
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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