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CompletedNCT03633136

A Randomized Controlled Trial of a Pre-Transplant Education Intervention

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
162 (actual)
Sponsor
University of Saskatchewan · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALelectronic video educationSolid 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.

Timeline

Start date
2018-06-01
Primary completion
2020-07-07
Completion
2020-07-07
First posted
2018-08-16
Last updated
2024-08-16

Locations

3 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT03633136. Inclusion in this directory is not an endorsement.

A Randomized Controlled Trial of a Pre-Transplant Education Intervention (NCT03633136) · Clinical Trials Directory