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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
Sponsor:
Collaborators:
Saskatchewan Health Authority - Regina Area
Southern Alberta Transplant Program
Multi-organ Transplant Program, Capitol Health Nova Scotia
University of Illinois Health Sciences System
American Society of Transplantation Research Network
Information provided by (Responsible Party):
Holly Mansell, University of Saskatchewan

Brief 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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Medication Adherence Behavioral: Video education + adherence contract Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Difference in education satisfaction between intervention and control [ Time Frame: 3 months and 12 months after enrolment ]
    Measured by self-report electronic survey

  5. 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.

  6. Difference in adherence to transplant appointments between intervention and control [ Time Frame: study end (12 months after enrolment) ]
    Captured by chart review

  7. 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.

  8. 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.

  9. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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"

Information from the National Library of Medicine

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


Contacts
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Contact: Holly Mansell, PharmD (306) 966 1512 holly.mansell@usask.ca

Locations
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United States, Illinois
University of Illinois Health Sciences System Recruiting
Chicago, Illinois, United States, 60612
Contact: Patricia West-Thielke       pwest@uic.edu   
Canada, Alberta
Southern Alberta Transplant Program Recruiting
Calgary, Alberta, Canada
Contact: Jenny Wichart       jenny.wichart@albertahealthservices.ca   
Canada, Saskatchewan
Saskatchewan Transplant Program Recruiting
Saskatoon, Saskatchewan, Canada
Contact: Nicola Rosaasen       nicola.rosaasen@saskhealthauthority.ca   
Sponsors and Collaborators
University of Saskatchewan
Saskatchewan Health Authority - Regina Area
Southern Alberta Transplant Program
Multi-organ Transplant Program, Capitol Health Nova Scotia
University of Illinois Health Sciences System
American Society of Transplantation Research Network

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Holly Mansell, Associate Professor, College of Pharmacy and Nutrition, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT03540121     History of Changes
Other Study ID Numbers: 99399
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Holly Mansell, University of Saskatchewan:
video
contract
patient education