Video Education and Behaviour Contract to Optimize Adherence in Renal Transplants

Kidney Transplantation Clinical Trial

— VECTOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03540121
• Other study ID #: 99399
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: University of Saskatchewan
• Contact: Holly Mansell, PharmD
• Phone: (306) 966 1512
• Email: holly.mansell[@]usask.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• 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

• receive their first kidney transplant at one of the participating sites during enrolment

Exclusion Criteria:

• do not meet inclusion criteria

• have previously participated in a study entitle "Improving health outcomes of kidney recipients: A randomized controlled trial of a pre-transplant education intervention"

Related Conditions & MeSH terms

• Kidney Transplantation
• Medication Adherence

Intervention

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.

Locations

Country	Name	City	State
Canada	Southern Alberta Transplant Program	Calgary	Alberta
Canada	Saskatchewan Transplant Program	Saskatoon	Saskatchewan
United States	University of Illinois Health Sciences System	Chicago	Illinois

Sponsors (8)

Lead Sponsor	Collaborator
University of Saskatchewan	American Society of Transplantation Research Network, Providence Health, St. Pauls Hospital - Renal Transplant Program, Saskatchewan Health Authority - Regina Area, Southern Alberta Transplant Program, University of Alberta Transplant Recipient Program, University of Illinois Health Sciences System, Vancouver Coastal Health

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in adherence to immunosuppressant medications between intervention and control (self-report)	The Basel Assessment of Adherence to Immunosuppressive medications (BAASIS) will be sent electronically by self-reported survey. An answer of 'yes' to any of the questions (pertaining to missing doses, drug holidays, timing, and dose reduction) will constitute non-adherence as a binary outcome. • A continuous measure of adherence will also be determined in each individual using a visual analogue scale.	3 months and 12 months after enrolment
Primary	Difference in adherence to immunosuppressant medications between intervention and control (immunosuppressant blood levels)	Immunosuppressant levels (tacrolimus, cyclosporine or sirolimus) will be collected as per routine practice, and will be standardized to the patient specific target. Intra-patient coefficients of variation (CV) will be used as a measure of trough level variability, and percentage of sub-therapeutic levels will be determined for each patient.	3 months and 12 months after enrolment
Secondary	Difference in changes in kidney transplant knowledge between intervention and control	Measured by the Kidney Transplant Understanding Tool (K-TUT) via 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.	3 months and 12 months after enrolment
Secondary	Difference in quality of life between intervention and control	Measured by the Short Form 12 (SF-12) via 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.	3 months and 12 months after enrolment
Secondary	Difference in self efficacy between intervention and control	Measured by the Generalized Self-Efficacy Scale (GSE) via 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.	3 months and 12 months after enrolment
Secondary	Difference in education satisfaction between intervention and control	Measured by self-report electronic survey	3 months and 12 months after enrolment
Secondary	Difference in beliefs about medication between intervention and control	Measured by the Beliefs of Medicine Questionnaire (BMQ) via 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.	3 months and 12 months after enrolment
Secondary	Difference in adherence to transplant appointments between intervention and control	Captured by chart review	study end (12 months after enrolment)
Secondary	Video viewing habits (duration of viewing time)	We will record the total duration that participants have watched each video (in minutes). This number will be divided by the total length of each video and used as a surrogate marker for whether each video was watched in its entirety.	study end (12 months after enrolment)
Secondary	Cost of administering the intervention	Staff time and other resources used in administering the intervention will be tracked and monetized using market wages and prices.	study end (12 months after enrolment)
Secondary	Days in hospital	The number of days in hospital will be collected by chart review at the end of the study period to estimate health care utilization.	study end (12 months after enrolment)

External Links

•   project website
•   Vector protocol, BMJ open
•   Video development manuscript