Clinical trial NCT03633136: A Randomized Controlled Trial of a Pre-Transplant Education Intervention
Official title: Improving Health Outcomes of Kidney Recipients: A Randomized Controlled Trial of a Pre-Transplant Education Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant
Patient Education
Quality of Life
Keywords: video
patient education
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Saskatchewan Health Authority - Regina Area
name: Southern Alberta Transplant Program
name: Saskatchewan Health Research Foundation
name: Saskatchewan Centre for Patient-Oriented Research
First posted: 2018-08-16
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in transplant knowledge score between the intervention and control groups as measured by the Kidney Transplant Understanding Tool (K-TUT)
timeFrame: 1 month
Secondary outcomes:
measure: Difference in self-efficacy between the intervention and control group as measured by the Generalized Self Efficacy Scale (GSE)
timeFrame: 1 month
measure: Difference in quality of life between the intervention and control group as measured by the Short Form-12 (SF-12)
timeFrame: 1 month
measure: Difference in beliefs of medicine between the intervention and control group as measured by the Beliefs of Medicine Questionnaire (BMQ)
timeFrame: 1 month
measure: Difference in education satisfaction between the intervention and control group as measured by self-reported electronic survey
timeFrame: 1 month
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Southern Alberta Transplant Program
state: Alberta
city: Regina
country: Canada
facility: Saskatchewan Transplant Program
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatchewan Transplant Program
state: Saskatchewan
Study officials:
References: