A Randomized Controlled Trial of a Pre-Transplant Education Intervention

Quality of Life Clinical Trial

Official title:

Improving Health Outcomes of Kidney Recipients: A Randomized Controlled Trial of a Pre-Transplant Education Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03633136
• Other study ID #: 99302
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: July 7, 2020

Study information

• Verified date: November 2020
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Kidney transplantation is the best treatment for most patients with end-stage kidney disease, but it is an extremely complicated process. To become active on the transplant waitlist, patients must learn new information, navigate the healthcare system and undergo several specialized tests. After the transplant, another set of challenges emerge. Transplant recipients must commit to lifelong therapy with immunosuppressive medications and adapt to lifestyle changes. Up to half of all patients have difficulty taking the medications as prescribed, which can lead to transplant rejection, kidney loss, and death. The transplant process is challenging and confusing; however, increasing education and support to transplant candidates demands greater use of care providers' time and resources in a health care system that is already stretched. A patient-oriented video series has been developed according to best practices for transplant education, featuring an animated character embarking on a transplant journey. Animated segments illustrate difficult concepts for patients with poor health literacy, and patient narratives provide support and encouragement. 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 and beliefs in medications as compared to usual care. Participants will be randomized (1:1) to the control group, or the intervention group, who will be provided access to the video series, in addition, to standard of care. Differences in changes in transplant knowledge, self-efficacy, beliefs about medicines, quality of life, and education satisfaction will be evaluated by a pre-and post-intervention survey. A thorough assessment of video-viewing habits and satisfaction with the intervention will provide insight on the feasibility of expanding home-based education to other health settings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: July 7, 2020
• Est. primary completion date: July 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• do not meet inclusion criteria

Related Conditions & MeSH terms

• Kidney Transplant
• Patient Education
• Quality of Life

Intervention

Behavioral:
• electronic video education
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.

Locations

Country	Name	City	State
Canada	Southern Alberta Transplant Program	Calgary	Alberta
Canada	Saskatchewan Transplant Program	Regina	Saskatchewan
Canada	Saskatchewan Transplant Program	Saskatoon	Saskatchewan

Sponsors (5)

Lead Sponsor	Collaborator
University of Saskatchewan	Saskatchewan Center for Patient-Oriented Research, Saskatchewan Health Authority - Regina Area, Saskatchewan Health Research Foundation, Southern Alberta Transplant Program

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference in self-efficacy between the intervention and control group as measured by the Generalized Self Efficacy Scale (GSE)	Measured by the Generalized Self Efficacy Scale (GSE) (self-reported electronic survey).The GSE measures an individual's self-beliefs in their ability to cope with various demands in life. It is a 10-item psychometric scale with a score for each item ranging from 1 to 4. The scores are summed and a higher score indicates stronger patient beliefs in self-efficacy.	1 month
Secondary	Difference in quality of life between the intervention and control group as measured by the Short Form-12 (SF-12)	Measured by the Short Form-12 (SF-12) (self-reported electronic survey). The SF-12 is a 12-item psychometric scale that measures functional health and well-being. Responses are indicated on a likert scale and aggregated into two sub scales; the mental component summary (MCS) and the physical component summary (PCS). The scores are converted to adjusted norm-based values of a healthy individual with a midpoint score of 50 indicating average health comparable to norm values.	1 month
Secondary	Difference in beliefs of medicine between the intervention and control group as measured by the Beliefs of Medicine Questionnaire (BMQ)	Measured by the Beliefs of Medicine Questionnaire (BMQ) (self-reported electronic survey). The BMQ is an 18-item psychometric questionnaire which consists of two subscales. The BMQ-Specific assesses perceptions of medication prescribed for personal use, while the BMQ-General assesses beliefs about medications in general. The BMQ-General can be further classified into domain of General-Harm and General-Overuse. Items are scored on a 5-point likert scale, with higher score indicating stronger beliefs in each subscale.	1 month
Secondary	Difference in education satisfaction between the intervention and control group as measured by self-reported electronic survey	Measured by self-reported electronic survey	1 month

External Links

•   project website
•   Video development manuscript