A Randomized Controlled Trial of a Pre-Transplant Education Intervention

NCT03633136 | Completed

• 1 other identifier: 99302
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 3

Brief Summary

A multi-center, randomized, controlled clinical trial will be conducted to test the effectiveness of a home-based video intervention on improving kidney transplant candidate's knowledge, self-efficacy, quality of life, beliefs in medications, and education satisfaction as compared to usual care.

Conditions

Kidney Transplant; Patient Education; Quality of Life

Keywords

video; patient education

Outcome Measures

Primary Outcomes (1)

• Change in transplant knowledge score between the intervention and control groups as measured by the Kidney Transplant Understanding Tool (K-TUT)

  Measured by the Kidney Transplant Understanding Tool (K-TUT) (self-reported electronic survey). The K-TUT consists of 9 true/false and 13 multiple-choice questions, and scores are based on the number correct answers \[YES/ NO format\] of 69 items.

  1 month

Secondary Outcomes (4)

• Difference in self-efficacy between the intervention and control group as measured by the Generalized Self Efficacy Scale (GSE)

  1 month

• Difference in quality of life between the intervention and control group as measured by the Short Form-12 (SF-12)

  1 month

• Difference in beliefs of medicine between the intervention and control group as measured by the Beliefs of Medicine Questionnaire (BMQ)

  1 month

• Difference in education satisfaction between the intervention and control group as measured by self-reported electronic survey

  1 month

Study Arms (2)

standard education

NO INTERVENTION

Standard of care education provided at each transplant center

electronic video education

EXPERIMENTAL

Standard education along with home-based video education. The videos will be initially viewed in the following order: Video 1: Introduction; Video 2: The Kidney; Video 3: Assessment and Waitlist; Video 4: Operation and Recovery; Video 5: Medications; Video 6: Your New Life. After the series has been viewed in its entirety one time, participants will be able to replay a specific video as often as desired.

Behavioral: electronic video education

Interventions

electronic video education BEHAVIORAL

Solid Organ Transplantation: An Educational Mini-Series for Patients consists of 6 videos ranging in length between 3 and 23 minutes, and has been developed according to best practice for designing education for patients with end-stage renal disease pursuing transplant. Each video outlines a subsequent stage of the transplant process, featuring an animated character embarking on a transplant journey. Animated segments illustrate difficult concepts for patients with poor health literacy, and patient narratives keep the content relevant and culturally inclusive. The educational intervention was developed with experts in medication adherence, video education, motivational psychology, cultural education (First Nations perspective), healthcare providers, and most importantly patients.

Also known as: Solid Organ Transplantation: An Educational Mini-Series for Patients

electronic video education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• or older
• can speak and understand and read English
• are being assessed or wait-listed for kidney transplantation

Sponsors & Collaborators

• University of Saskatchewan: lead
• Saskatchewan Health Authority - Regina Area: collaborator
• Southern Alberta Transplant Program: collaborator
• Saskatchewan Health Research Foundation: collaborator
• Saskatchewan Centre for Patient-Oriented Research: collaborator

Study Sites (3)

Southern Alberta Transplant Program

Calgary, Alberta, Canada

Location

Saskatchewan Transplant Program

Regina, Saskatchewan, Canada

Location

Saskatchewan Transplant Program

Saskatoon, Saskatchewan, Canada

Location

Related Links

• project website
• Study Results

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, College of Pharmacy and Nutrition

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 16, 2018
• Study Start: June 1, 2018
• Primary Completion: July 7, 2020
• Study Completion: July 7, 2020
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)