Teen Adherence in KidnEy Transplant Improving Tracking To Optimize Outcomes - Stage 3

Summary

Medication non-adherence is a major problem in kidney transplant recipients; young people 12-24 years of age are at particularly high risk for non-adherence and graft failure compared to young children and adults. Given that poor medication contributes greatly to graft failure, clinically feasible and effective interventions are urgently needed to improve adherence, survival, and quality of life in this population. The broad aim of this prospective, 3-stage, sequential study is to improve medication adherence in adolescent kidney transplant recipients by: 1) adapting the successful Teen Adherence in Kidney transplant Effectiveness of Intervention Trial (TAKE-IT) intervention for use in 'real world' clinical care, 2) designing and testing a new portable electronic pillbox and companion tracking website interface, and 3) preliminary testing of the adapted intervention.

Conditions

• Medication Adherence
• Kidney Transplantation

Interventions

BEHAVIORAL

Adherence Intervention

Intervention: * Adherence Support Team (patient, parent or a significant other, Coach) * Standardized educational videos on immunosuppressive medications, rejection, and improving adherence * Identification of adherence barriers, self-efficacy for medication-taking, and allocation of treatment responsibility * 'Action-Focused Problem-Solving' to address barriers selected as most important by the patient Device: * Electronic pillbox monitoring with text message and/or audio/visual dose reminders and access to e-pillbox website * Feedback of electronic monitoring data at increasing intervals between initiation of the intervention at 4-week and exit at 14-week.

OTHER

Healthy living education intervention

Intervention: * Standardized educational videos on immunosuppressive medications, rejection, and improving adherence * Healthy living topic discussion at increasing intervals between 4-wk and 14-wk visits * 'Action-Focused Problem-Solving' to address barriers on healthy living topic selected by the patient Device: • Electronic adherence monitoring without dose reminders or feedback (enrollment to 14w)

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  lead OTHER

Principal Investigators

• Bethany J Foster, MD, MSCE · Montreal Children's Hospital of the MUHC

• Annette DeVito Dabbs, PhD · University of Pittsburgh Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

24 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-04

Primary Completion

2023-01-19

Completion

2023-06-30

Countries

• United States
• Canada

Study Locations