Information-Assisted Intervention for Potential Living Kidney Donors

April 6, 2026 updated by: Ching-Hui Chien, National Taipei University of Nursing and Health Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taoyuan District, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (T0, prior to intervention), 4 weeks (T1) and 8 weeks (T2) after Baseline
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.
Baseline (T0, prior to intervention), 4 weeks (T1) and 8 weeks (T2) after Baseline
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.
Baseline (T0, prior to intervention), 4 weeks (T1) and 8 weeks (T2) after Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (T0, prior to intervention), 4 weeks (T1) and 8 weeks (T2) after Baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (T0, prior to intervention)
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.
4 weeks (T1) after Baseline
Demographic and Clinical Characteristics-Age
Time Frame: Baseline (T0, prior to intervention)
Actual age (years)
Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Sex
Time Frame: Baseline (T0, prior to intervention)
Male / Female
Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Marital Status
Time Frame: Baseline (T0, prior to intervention)
Single, Married, Divorced, Separated, Widowed, Cohabiting
Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Education
Time Frame: Baseline (T0, prior to intervention)
None, Elementary, Junior High, Senior High, College/University, Graduate/Doctorate, Other
Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Religion
Time Frame: Baseline (T0, prior to intervention)
None, Taoism, Buddhism, Catholicism, Christianity, I-Kuan Tao, Other
Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Occupation
Time Frame: Baseline (T0, prior to intervention)
None, Physically demanding, Mentally demanding, Both, Neither, Retired, Other
Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Relationship to Recipient
Time Frame: Baseline (T0, prior to intervention)
Spouse, Sibling, Parent-child, Relative, Other
Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Perceived Health Status
Time Frame: Baseline (T0, prior to intervention)
One item; Score range 0-100; higher = better health perception
Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Chronic Diseases
Time Frame: Baseline (T0, prior to intervention)
None, Diabetes, Hypertension, Heart disease, Asthma, Bronchitis, Other
Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Serum Creatinine (mg/dL)
Time Frame: Baseline (T0, prior to intervention)
Higher values indicate poorer renal function
Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-24-h Creatinine Clearance (mL/min)
Time Frame: Baseline (T0, prior to intervention)
Higher values indicate better renal function
Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Estimated GFR (mL/min/1.73m²)
Time Frame: Baseline (T0, prior to intervention)
Higher values indicate better renal function
Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Urine Protein
Time Frame: Baseline (T0, prior to intervention)
None, Present, Other
Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Serum Creatinine-Body Weight (kilograms)
Time Frame: Baseline (T0, prior to intervention)
Measured in kilograms
Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Height (centimeters)
Time Frame: Baseline (T0, prior to intervention)
Measured in centimeters
Baseline (T0, prior to intervention)
Demographic and Clinical Characteristics-Information Source
Time Frame: Baseline (T0, prior to intervention)
None, Physician, Transplant Coordinator, Nurse/NP, Other
Baseline (T0, prior to intervention)
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
Baseline (T0, prior to intervention), 4 weeks (T1) and 8 weeks (T2) after Baseline
Demographic and Clinical Characteristics-Family Support
Time Frame: Baseline (T0, prior to intervention)
Supportive, Neutral, Not supportive
Baseline (T0, prior to intervention)
Recipient-Related Clinical Data-Dialysis Treatment
Time Frame: Baseline (T0, prior to intervention)
Yes / No (Hemodialysis or Peritoneal Dialysis)
Baseline (T0, prior to intervention)
Recipient-Related Clinical Data-Serum Creatinine (mg/dL)
Time Frame: Baseline (T0, prior to intervention)
Higher values indicate poorer renal function
Baseline (T0, prior to intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taipei University of Nursing and Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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