Information-Assisted Intervention for Potential Living Kidney Donors

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorNational Taipei University of Nursing and Health Sciences

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Information-Assisted Intervention

    Other 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.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Information-Assisted groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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

Other outcomes

1

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)
2

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
3

Demographic and Clinical Characteristics-Age

Actual age (years)

Time frame
Baseline (T0, prior to intervention)
4

Demographic and Clinical Characteristics-Sex

Male / Female

Time frame
Baseline (T0, prior to intervention)

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