Clinical trial NCT03540121: Video Education and Behaviour Contract to Optimize Adherence in Renal Transplants
Official title: Improving Adherence in Kidney Recipients: a Randomized Controlled Trial of a Post-transplant Education Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplantation
Medication Adherence
Keywords: video
contract
patient education
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Saskatchewan Health Authority - Regina Area
name: Southern Alberta Transplant Program
name: University of Illinois Health Sciences System
name: American Society of Transplantation Research Network
name: University of Alberta Transplant Recipient Program
name: Vancouver Coastal Health
name: Providence Health, St. Pauls Hospital - Renal Transplant Program
First posted: 2018-05-30
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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"

Primary outcomes:
measure: Difference in adherence to immunosuppressant medications between intervention and control (self-report)
timeFrame: 3 months and 12 months after enrolment
measure: Difference in adherence to immunosuppressant medications between intervention and control (immunosuppressant blood levels)
timeFrame: 3 months and 12 months after enrolment
Secondary outcomes:
measure: Difference in changes in kidney transplant knowledge between intervention and control
timeFrame: 3 months and 12 months after enrolment
measure: Difference in quality of life between intervention and control
timeFrame: 3 months and 12 months after enrolment
measure: Difference in self efficacy between intervention and control
timeFrame: 3 months and 12 months after enrolment
measure: Difference in education satisfaction between intervention and control
timeFrame: 3 months and 12 months after enrolment
measure: Difference in beliefs about medication between intervention and control
timeFrame: 3 months and 12 months after enrolment
measure: Difference in adherence to transplant appointments between intervention and control
timeFrame: study end (12 months after enrolment)
measure: Video viewing habits (duration of viewing time)
timeFrame: study end (12 months after enrolment)
measure: Cost of administering the intervention
timeFrame: study end (12 months after enrolment)
measure: Days in hospital
timeFrame: study end (12 months after enrolment)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Health Sciences System
state: Illinois
city: Calgary
country: Canada
facility: Southern Alberta Transplant Program
state: Alberta
city: Saskatoon
country: Canada
facility: Saskatchewan Transplant Program
state: Saskatchewan
Study officials:
References:
citation: 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.
citation: 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.