NCT03540121

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 16, 2024

Status Verified

August 1, 2024

Enrollment Period

4.5 years

First QC Date

April 27, 2018

Last Update Submit

August 14, 2024

Conditions

Kidney TransplantationMedication Adherence

Keywords

videocontractpatient education

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (9)

  • Difference in changes in kidney transplant knowledge between intervention and control

    3 months and 12 months after enrolment

  • Difference in quality of life between intervention and control

    3 months and 12 months after enrolment

  • Difference in self efficacy between intervention and control

    3 months and 12 months after enrolment

  • Difference in education satisfaction between intervention and control

    3 months and 12 months after enrolment

  • Difference in beliefs about medication between intervention and control

    3 months and 12 months after enrolment

  • +4 more secondary outcomes

Study Arms (2)

Video education + adherence contract

EXPERIMENTAL

electronically delivered video education (at transplant discharge) + electronic adherence contract (1 month after enrolment)

Behavioral: Video education + adherence contract

Standard education

NO INTERVENTION

standard of care education provided at each transplant center (control emails will be provided at intervention time points)

Interventions

Video education + adherence contractBEHAVIORAL

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.

Also known as: Solid Organ Transplantation: An Educational Mini-Series for Patients
Video education + adherence contract

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • or older
  • can speak and understand and read English
  • receive their first kidney transplant at one of the participating sites during enrolment

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Illinois Health Sciences System

Chicago, Illinois, 60612, United States

Location

Southern Alberta Transplant Program

Calgary, Alberta, Canada

Location

Saskatchewan Transplant Program

Saskatoon, Saskatchewan, Canada

Location

Related Publications (3)

  • 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.

    PMID: 39100428DERIVED

  • 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.

    PMID: 36094829DERIVED

  • 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.

    PMID: 30872550DERIVED

Related Links

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, College of Pharmacy and Nutrition

Study Record Dates

First Submitted

April 27, 2018

First Posted

May 30, 2018

Study Start

July 1, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

August 16, 2024

Record last verified: 2024-08

Locations

US(1)CA(2)