NCT04288271

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
2 countries

8 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

December 18, 2017

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
1.9 years until next milestone

Study Start

First participant enrolled

February 4, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

12 months

First QC Date

December 18, 2017

Last Update Submit

March 14, 2024

Conditions

Medication AdherenceKidney Transplantation

Keywords

pediatricadolescentrenalallograftimmunosuppressiveimmunosuppressionadherencemedicationyoung adultmobile healthcompliancerandomized trialelectronic pillbox

Outcome Measures

Primary Outcomes (2)

  • Taking Adherence

    percentage of prescribed doses taken each day (as measured by electronic monitoring). The daily taking adherence score could take a value of 0%, 50%, or 100% for patients on twice-daily dosing, and 0% or 100% for patients on once-daily dosing. Each patient will have a taking adherence score for every day of observation (repeated measures). On days that the pillbox was not in use due to technical problems or participant non-use, no score will be given. To summarize adherence for each arm, the total percentage of days of observation for which there was 100% taking adherence will be calculated. The denominator for this calculation will be the total number of days of observation of each participant summed across all participants; the numerator will be the total number of days of observation of each participant for which taking adherence was 100% summed across all participants.

    14 weeks

  • Timing Adherence

    percentage of doses taken within 2 hours before to 2 hours after the prescribed dosing time each day (as measured by electronic monitoring). The daily timing adherence score could take a value of 0%, 50%, or 100% for patients on twice-daily dosing, and 0% or 100% for patients on once-daily dosing. Each patient will have a timing adherence score for every day of observation (repeated measures). On days that the pillbox was not in use due to technical problems or participant non-use, no score will be given. To summarize timing adherence for each arm, the total percentage of days of observation for which there is 100% timing adherence will be calculated. The denominator for this calculation will be the total number of days of observation of each participant summed across all participants; the numerator will be the total number of days of observation of each participant for which timing adherence is 100% summed across all participants.

    14 weeks

Secondary Outcomes (2)

  • Self-reported Taking Adherence

    14 weeks (at baseline, 4-week, 6-week, 10-weeks, 14-week visits)

  • Self-reported Timing Adherence

    14 weeks (at baseline, 4-week, 6-week, 10-weeks, 14-week visits)

Other Outcomes (7)

  • Recruitment feasibility: number of participants enrolled at each site

    3 months

  • Acceptability of e-pillbox: PSSUQ

    14 weeks

  • Acceptability of tracking website: PSSUQ

    10 weeks

  • +4 more other outcomes

Study Arms (2)

Adherence Intervention

EXPERIMENTAL

The objective of the intervention is to improve medication adherence. Patient-participants will use a multi-dose electronic pillbox and adherence tracking website which can provide dose reminders. Patient will form an Adherence Support Team (AST) including the participant, a parent (or other) and the "Coach" (study coordinator). The Coach will guide the AST to use Action-focused Problem-solving to address personal barriers to adherence. They will then generate concrete "if-then" plans for how they will behave in a given situation. Intervention participants with excellent adherence will be encouraged to work on building autonomy in medication-taking instead of adherence. Action plans will be able to be modified, if desired, at the 6-week and 10-week check-ins. HCP-participants at intervention sites will be given the option to login to the adherence tracking website to view the adherence data of their patients. They will also be alerted by study staff to critical non-adherence events.

Behavioral: Adherence Intervention

Healthy Living Education Intervention

OTHER

Patient-participants will receive a healthy living education intervention with the use of an e-pillbox. Contacts with the coach will occur at the same intervals as at adherence intervention sites. Participants will choose one of 3 healthy living topics on which they will receive education in an interactive format. The coach will engage the participant in a semi-scripted conversation on the selected topic. At check-ins, the coach will either continue the conversation on the topic selected at the outset or provide education on another topic. The coach will NOT engage in discussions about adherence and will NOT provide feedback on adherence data.

Other: Healthy living education intervention

Interventions

Adherence InterventionBEHAVIORAL

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.

Also known as: Action-focused problem-solving, Electronic multi-dose pillbox monitoring system, Medy Box, Portable e-pillbox
Adherence Intervention
Healthy living education interventionOTHER

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)

Healthy Living Education Intervention

Eligibility Criteria

Age12 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • kidney-only transplant recipients, who are ≥3 months post-transplant
  • Aged 12 to 24 years
  • Patients followed at one of the study sites

You may not qualify if:

  • Patients with significant neurocognitive disabilities limiting their ability to understand and participate in their own care (as judged by the parents and the healthcare team)
  • Patients unable to communicate in English or French (Montreal sites only)
  • Multi-organ transplant recipients
  • Patient has a sibling participating in Stage 3
  • Patients with no internet access
  • Parents of patients 18-24 years old will be excluded as the older aged group is expected to be primarily responsible for their own care, independent of their parents. One parent per family will be eligible to avoid redundant representation.
  • Representatives from the variety of disciplines typically involved in promoting medication adherence as deemed appropriate from each center.
  • HCP from adherence intervention sites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

St-Louis Children's Hospital

St Louis, Missouri, 63110-1002, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140-5102, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213-2536, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105-3901, United States

Location

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

University of Toronto Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

CHU Ste-Justine

Montreal, Quebec, H3T 1C4, Canada

Location

MeSH Terms

Conditions

Medication AdherencePatient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Bethany J Foster, MD, MSCE

    Montreal Children's Hospital of the MUHC

    PRINCIPAL INVESTIGATOR

  • Annette DeVito Dabbs, PhD

    University of Pittsburgh Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants (patient-, parent- and HCP-participants) will be blinded to group allocation but, given the nature of the intervention, study coordinators who will be acting as coaches must be aware of group allocation.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of the Department of Pediatrics

Study Record Dates

First Submitted

December 18, 2017

First Posted

February 28, 2020

Study Start

February 4, 2022

Primary Completion

January 19, 2023

Study Completion

June 30, 2023

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Data generated will be available for use to other investigators in the research community. Data may be used for hypothesis testing, and to generate preliminary data in support of future research projects. A Data Sharing Committee, composed site investigators will review requests submitted for use of the data. If the request is approved, the appropriate data analysis will be performed and the results sent to the requesting investigator. Alternatively, depending on the request, it may be more appropriate to provide the requesting investigator with certain segments of the data. If this is the case, a file of the requested data (de-identified) will be provided to the investigator

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be available within 12 months of publication of the study's main findings.
Access Criteria
Request for data submitted in writing. May require payment for costs associated with extracting the required data.

Locations

US(4)CA(4)