NCT03540121

Video Education and Behaviour Contract to Optimize Adherence in Renal Transplants

Improving Adherence in Kidney Recipients: a Randomized Controlled Trial of a Post-transplant Education Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: University of Saskatchewan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to test the effectiveness of an electronic-based video intervention and behavioral contract on improving medication adherence among kidney transplant recipients.

Detailed description

Non-adherence to immunosuppressive medications is a major problem after kidney transplantation, leading to increased rejections, hospitalizations and health care expenditures. Effective educational opportunities may positively influence adherence, especially when combined with a behavior intervention. However, increasing education and support to transplant recipients 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 multicenter randomized controlled trial will be conducted with 4 sites across North America. Patients will be randomized (1:1) to either the intervention (i.e., home-based video education + adherence contract plus usual care) or usual care alone. Patients will be enrolled in the study prior to hospital discharge and will be provided with access to the video intervention and contract electronically. The primary outcome will be adherence at 12 months post-transplant, as measured by self-report (BAASIS), and variability in immunosuppressant levels. Secondary outcomes include the change in knowledge score between the intervention and control in groups (measured by the Kidney Transplant Understanding Tool); differences in self-efficacy (Generalized Self-efficacy Scale), beliefs about medicines (Beliefs of Medicine Questionnaire), and quality of life (SF-12). Individualized viewing statistics will be analyzed to determine patient uptake, and satisfaction about the educational experience will be captured on a self-reported survey.

Conditions

• Kidney Transplantation
• Medication Adherence

Interventions

Type	Name	Description
BEHAVIORAL	Video education + adherence contract	Participants will receive standard education along with the home-based video education plus an adherence contract. Following the baseline assessment, access to videos will be provided electronically so that the patient can watch them at home. The videos will be initially viewed in the following order: Video 1: Introduction, Video 2: Medications, Video 3: Your New Life. Approximately one month after transplant, after the video series has been viewed in its entirety, participants will receive an email link inviting participants to reflect on their goals about transplantation and pledging to taking their medications as directed. The contract will be non-enforceable, but it will provide patients with the opportunity to formally commit to a goal of taking the medications as prescribed. At 3 months, and 12 months, the participant will have the opportunity to reflect and modify adherence goals as desired.

Timeline

• Start date: 2018-07-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2018-05-30
• Last updated: 2024-08-16

Locations

3 sites across 2 countries: United States, Canada