NCT07017556

Brief Summary

The goal of this pilot study is to find out whether educational videos can help patients better understand, and remember, important information regarding the benefits and risks of having a kidney transplant. The study aims to answer several questions, including:

  1. 1.Is the video-based educational intervention acceptable and feasible for kidney transplant patients?
  2. 2.Does the intervention improve patient knowledge and satisfaction immediately after viewing?
  3. 3.Does the intervention improve patient knowledge retention a week later?
  4. 4.What are patients views on the video format as an educational tool?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

8 months

First QC Date

May 26, 2025

Last Update Submit

June 11, 2025

Conditions

Keywords

mixed-methodspilot studyeducationend-stage renal diseasekidney transplantationfeasibility studyrepeated measuresvideo-based educationkidney disease

Outcome Measures

Primary Outcomes (7)

  • Patient satisfaction with existing educational information

    The Satisfaction with Existing Information questionnaire will be used to assess participants' satisfaction with the existing information received from their kidney transplant team. This will be used to help assess participants baseline satisfaction with standard kidney transplant education materials.

    T1 - Day 1 (Immediately pre-video viewing).

  • Patient understanding of kidney transplantation benefits and risks - Benefits

    One open-ended question will assess patient understanding of the benefits of kidney transplantation. This will be used to assess whether patient understanding of the benefits of transplantation changes from immediately pre-video viewing, to immediately post-viewing, and at one week follow-up.

    Patient understanding will be assessed at all three time points: T1 - Day 1 (Immediately pre-video viewing), T2 - Day 1 (Immediately post-video viewing), T3 - Day 7 (One week follow-up)

  • Patient understanding of kidney transplantation benefits and risks - Risks

    One open-ended question will assess patient understanding of the risks of kidney transplantation. This will be used to assess whether patient understanding of the risks of transplantation changes from immediately pre-video viewing, to immediately post-viewing, and at one week follow-up.

    Patient understanding will be assessed at all three time points: T1 - Day 1 (Immediately pre-video viewing), T2 - Day 1 (Immediately post-video viewing), T3 - Day 7 (One week follow-up)

  • Patient Satisfaction with video educational materials

    The Satisfaction with Study Materials questionnaire will be used to assess participants' satisfaction with the video educational materials received from the research team. This will be used to assess participant satisfaction and to understand if the materials are coherent to participants, or if changes may be needed to make the materials more accessible, understandable, and effective.

    T2 - Day 1 (Immediately post-video viewing), T3 - Day 7 (One week follow-up)

  • Acceptability and usefulness of the study video resources (Qualitative)

    A semi-structured (15-20 minute) qualitative interview will take place at T2. This interview will explore patient thoughts of the materials beyond the questionnaires which they will receive. These interviews will explore participants' experience with the video material, including its perceived impact on benefits and risks understanding, and participant satisfaction with the Video-Based Educational materials - including acceptability, clarity and perceived usefulness. Interviews will explore suggestions for improving the intervention. Interview audio will be recorded and transcribed for thematic analysis.

    T2 - Day 1 (Immediately post-video viewing).

  • Patient understanding of their disease

    The Brief Illness Perceptions Questionnaire (BIPQ) (Broadbent et al., 2006) will be used to assess participants' cognitive and emotional responses to their kidney transplantation; this will be used to help assess participants emotional response to both the risks and benefits of kidney transplantation.

    The BIPQ will be used at all three timepoints. T1 - Day 1 (Immediately pre-video viewing), T2 - Day 1 (Immediately post-video viewing), T3 - Day 7 (One week follow-up)

  • Patient adherence to their medication

    The investigators will utilise questions from the Anticipated Adherence Index (AAI) (Wright, 2022) to identify if there is any change across timepoints for the participants views on the medication they are / will be taking, their intention to take their medication, and the importance of this medication to participants' long-term wellbeing.

    The AAI will be assessed at all three time points. T1 - Day 1 (Immediately pre-viewing), T2 - Day 1 (Immediately post-viewing), T3 - Day 7 (One week follow-up)

Study Arms (1)

Video-Based Education (Pre / Post Transplant Patients)

EXPERIMENTAL

The study uses a single educational intervention for all participants. Participants are recruited from two subgroups: Pre-transplant patients, and post-transplant patients. All participants will watch the same educational videos (2 videos, each under five minutes) explaining important kidney transplant risks and benefits. These videos are designed to support the standard written and verbal information that patients receive. Information will be collected from participants at three time points: T1 (Day 1) - Immediately pre-video viewing. T2 (Day 1) - Immediately post-video viewing (the investigators will also conduct a short interview at this point). T3 (Day 7) - One week follow-up. Participants' knowledge and satisfaction will be assessed at each time point. Participants will also be interviewed to allow us to better understand their opinions. Analysis will examine differences by transplant status, but participants receive the same intervention.

Behavioral: Views on Information Resources for Kidney Transplantation Patients

Interventions

A pilot study to improve kidney transplant patient education. The study explores whether videos help patients to better understand and remember important information regarding the benefits and risks of receiving a kidney transplant. Currently, patients receive transplant information through written materials, and clinician discussions. However, not everyone has the same level of language literacy and medical understanding, which can lead to critical knowledge gaps, misunderstandings, and misinterpretations. Patients may also not know about lifelong medication needs, and complications which may follow transplantation, such as diabetes, making patient education and understanding essential. This study explores whether video materials helps patients feel more informed and satisfied with the clinical information they receive, and whether they can better retain this information. The investigators aim to support more informed patients, making transplant education clearer, and accessible.

Video-Based Education (Pre / Post Transplant Patients)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pre-transplant patients are on the kidney transplant wait list
  • Post-transplant patients have received a transplant within the last 12 months.
  • Participants are 18 years or over.
  • Participants can read and understand English.
  • Participants are located within the Auckland Metro region.

You may not qualify if:

  • Any impairments preventing informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Auckland City Hospital

Auckland, Auckland, 1023, New Zealand

Location

MeSH Terms

Conditions

Kidney Failure, ChronicKidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kate MacKrill, Dr

    University of Auckland, New Zealand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Darren Manden

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This study uses a single educational intervention across all participants. Participants are recruited from two subgroups: 1. Pre-transplant patients - Recruited from the kidney transplant waitlist. 2. Post-transplant patients - Recruited from post-transplant clinics. All participants receive the same educational resources (two short videos explaining the risks and benefits of kidney transplantation). The only difference between the subgroups is their transplant status, otherwise the intervention is the same for everyone.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 26, 2025

First Posted

June 12, 2025

Study Start

June 1, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

The investigators make available de-identified data available for Māori researchers upon reasonable request. Specifically: The investigators allow Māori organisations to access de-identified study data, for uses that may benefit Māori.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
By the time recruitment opens (estimated June 2025), and for no less than a year following publication of results.
Access Criteria
Māori researchers on reasonable request to the research team. People will receive a password protected Excel file containing the de-identified data.

Locations