Video Education and Behaviour Contract to Optimize Adherence in Renal Transplants
NCT ID: NCT03540121
Last Updated: 2024-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
173 participants
INTERVENTIONAL
2018-07-01
2022-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Video education + adherence contract
electronically delivered video education (at transplant discharge) + electronic adherence contract (1 month after enrolment)
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.
Standard education
standard of care education provided at each transplant center (control emails will be provided at intervention time points)
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* can speak and understand and read English
* receive their first kidney transplant at one of the participating sites during enrolment
* have previously participated in a study entitle "Improving health outcomes of kidney recipients: A randomized controlled trial of a pre-transplant education intervention"
18 Years
ALL
No
Sponsors
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Saskatchewan Health Authority - Regina Area
OTHER
Southern Alberta Transplant Program
UNKNOWN
University of Illinois Health Sciences System
UNKNOWN
American Society of Transplantation Research Network
UNKNOWN
University of Alberta Transplant Recipient Program
UNKNOWN
Vancouver Coastal Health
OTHER_GOV
Providence Health, St. Pauls Hospital - Renal Transplant Program
UNKNOWN
University of Saskatchewan
OTHER
Responsible Party
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Holly Mansell
Associate Professor, College of Pharmacy and Nutrition
Locations
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University of Illinois Health Sciences System
Chicago, Illinois, United States
Southern Alberta Transplant Program
Calgary, Alberta, Canada
Saskatchewan Transplant Program
Saskatoon, Saskatchewan, Canada
Countries
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References
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Mansell H, Rosaasen N, Wichart J, West-Thielke P, Blackburn D, Liu J, Mainra R, Shoker A, Groot B, Wen K, Wong A, Bateni B, Luo C, Trivedi P. Video Education and Behavior Contract to Improve Outcomes After Renal Transplantation (VECTOR): A Randomized Controlled Trial. Patient Prefer Adherence. 2024 Jul 31;18:1589-1602. doi: 10.2147/PPA.S467142. eCollection 2024.
Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
Mansell H, Rosaasen N, West-Thielke P, Wichart J, Daley C, Mainra R, Shoker A, Liu J, Blackburn D. Randomised controlled trial of a video intervention and behaviour contract to improve medication adherence after renal transplantation: the VECTOR study protocol. BMJ Open. 2019 Mar 13;9(3):e025495. doi: 10.1136/bmjopen-2018-025495.
Related Links
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project website
Vector protocol, BMJ open
Other Identifiers
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99399
Identifier Type: -
Identifier Source: org_study_id
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