Clinical trial NCT07017556: Views on Information Resources for Kidney Transplantation Patients
Official title: An Exploratory Mixed-Methods Pilot Study on the Use of Educational Videos to Improve Knowledge and Satisfaction in Kidney Transplantation Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: End-Stage Renal Disease
Keywords: mixed-methods
pilot study
education
end-stage renal disease
kidney transplantation
feasibility study
repeated measures
video-based education
kidney disease
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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

At the moment, patients learn about kidney transplantation through written documents, and discussions and conversations with their clinicians / doctors. However, the concern here is that not everyone has the same level of understanding when it comes to language literacy, medical jargon and information. This can result in gaps in knowledge, misunderstandings, and / or misinterpretations, including the need for lifelong medication and possible post-transplant complications.

Patients understanding of the benefits and risks of transplantation is extremely important, as there are aspects which patients may not be aware of, including the need for (and importance of) lifelong medication, and also potential disease complications which may follow transplantation. For example, following a kidney transplant, it is not uncommon for patients to develop diabetes.

Participants in the study will:

Watch two short videos (roughly five minutes each) that explain the benefits and risks of kidney transplantation.

Answer some questions before video viewing, immediately after video viewing, and one week after video viewing.

Complete a short interview to give deeper feedback on the videos.

This study will explore whether using video helps patients to feel more informed and also 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, more accessible, and generally easier to understand.

Detailed description: This will be a mixed-methods, repeated-measures, non-randomised pilot study. The design uses both quantitative and qualitative components to explore the feasibility and effectiveness of short (approximately five minutes each) educational videos for improving kidney transplant patient knowledge, knowledge retention, and information satisfaction.

A power analysis was conducted using G-Power to determine the participant sample size necessary for detecting a meaningful within-group effect of the intervention for both patient knowledge and information satisfaction. To detect a medium effect size (f = 0.21) with a power of 0.80 and an alpha level of .05, a total sample size of 60 participants (30 pre-transplant, and 30 post-transplant) is required.

Two subgroups (30 people each) - pre-transplant and post-transplant patients - will receive the same intervention with data collected through questionnaires (assessing knowledge, knowledge retention and satisfaction with the educational information) at three time points: Immediately pre-intervention (T1), immediately post-intervention (T2), and at a one-week follow-up (T3).

A semi-structured interview will take place immediately following the intervention (T2) exploring participants qualitative impressions of the videos and participant's assessment of the video's acceptability and the usefulness of the format.

The study will help to determine whether video-based education is a feasible and acceptable method for delivering kidney transplantation information, and whether it can improve participant understanding and satisfaction over traditional educational formats. The findings can then inform the design of a future larger-scale trial.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Any impairments preventing informed consent.

Primary outcomes:
measure: Patient satisfaction with existing educational information
timeFrame: T1 - Day 1 (Immediately pre-video viewing).
measure: Patient understanding of kidney transplantation benefits and risks - Benefits
timeFrame: 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)
measure: Patient understanding of kidney transplantation benefits and risks - Risks
timeFrame: 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)
measure: Patient Satisfaction with video educational materials
timeFrame: T2 - Day 1 (Immediately post-video viewing), T3 - Day 7 (One week follow-up)
measure: Acceptability and usefulness of the study video resources (Qualitative)
timeFrame: T2 - Day 1 (Immediately post-video viewing).
measure: Patient understanding of their disease
timeFrame: 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)
measure: Patient adherence to their medication
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
affiliation: University of Auckland, New Zealand
name: Kate MacKrill, Dr
role: PRINCIPAL_INVESTIGATOR
References: