Video Education and Behaviour Contract to Optimize Adherence in Renal Transplants (VECTOR)
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|ClinicalTrials.gov Identifier: NCT03540121|
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : July 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplantation Medication Adherence||Behavioral: Video education + adherence contract||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Improving Adherence in Kidney Recipients: a Randomized Controlled Trial of a Post-transplant Education Intervention|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: Video education + adherence contract
electronically delivered video education (at transplant discharge) + electronic adherence contract (1 month after enrolment)
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.
Other Name: Solid Organ Transplantation: An Educational Mini-Series for Patients
No Intervention: Standard education
standard of care education provided at each transplant center (control emails will be provided at intervention time points)
- Difference in adherence to immunosuppressant medications between intervention and control (self-report) [ Time Frame: 3 months and 12 months after enrolment ]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.
- Difference in adherence to immunosuppressant medications between intervention and control (immunosuppressant blood levels) [ Time Frame: 3 months and 12 months after enrolment ]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.
- Difference in changes in kidney transplant knowledge between intervention and control [ Time Frame: 3 months and 12 months after enrolment ]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.
- Difference in quality of life between intervention and control [ Time Frame: 3 months and 12 months after enrolment ]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.
- Difference in self efficacy between intervention and control [ Time Frame: 3 months and 12 months after enrolment ]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.
- Difference in education satisfaction between intervention and control [ Time Frame: 3 months and 12 months after enrolment ]Measured by self-report electronic survey
- Difference in beliefs about medication between intervention and control [ Time Frame: 3 months and 12 months after enrolment ]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.
- Difference in adherence to transplant appointments between intervention and control [ Time Frame: study end (12 months after enrolment) ]Captured by chart review
- Video viewing habits (duration of viewing time) [ Time Frame: study end (12 months after enrolment) ]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.
- Cost of administering the intervention [ Time Frame: study end (12 months after enrolment) ]Staff time and other resources used in administering the intervention will be tracked and monetized using market wages and prices.
- Days in hospital [ Time Frame: study end (12 months after enrolment) ]The number of days in hospital will be collected by chart review at the end of the study period to estimate health care utilization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03540121
|Contact: Holly Mansell, PharmD||(306) 966 firstname.lastname@example.org|
|United States, Illinois|
|University of Illinois Health Sciences System||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Patricia West-Thielke email@example.com|
|Southern Alberta Transplant Program||Recruiting|
|Calgary, Alberta, Canada|
|Contact: Jenny Wichart firstname.lastname@example.org|
|Saskatchewan Transplant Program||Recruiting|
|Saskatoon, Saskatchewan, Canada|
|Contact: Nicola Rosaasen email@example.com|