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Kidney TransplantationTAKE-ITNCT01356277

Intervention to Improve Adherence in Teen Kidney Transplant

A study testing Action-focused problem-solving and Electronic pillbox monitoring, dose reminders, and feedback in people with Kidney Transplantation and Medication Adherence, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The broad aim of the proposed study is to improve medication adherence in adolescent kidney transplant recipients. The investigators hypothesize that a multi-component intervention will improve medication adherence in the adolescent kidney transplant population. Read more about this study

Who is it for?
Ages 11 to 24 years
Conditions the study is for
Kidney Transplantation, Medication Adherence
What is being tested?
Action-focused problem-solving and Electronic pillbox monitoring, dose reminders, and feedback
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
8 sitesin 2 countries
Study dates
Feb 2012to Jun 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 24 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Subjects age 11 - 24 years
  • At least 3 months post kidney transplant

Who cannot join

  • Significant neurocognitive disabilities limiting the subject's ability to understand and participate on their own
  • Unable to communicate in English or French (Montreal site)
  • Unable to communicate in English (all other sites)

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

United States4 sites

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Seattle Children's Hospital

    Seattle, Washington, 98105

  • Washington University School of Medicine

    St Louis, Missouri, 63130

Other trials in United States

Canada4 sites

  • Montreal Children's Hospital

    Montreal, Quebec, H3G 1AF

  • St. Justine's Hospital

    Montreal, Quebec

  • University of Toronto Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

  • British Columbia Children's Hospital

    Vancouver, British Columbia, V6H 3V4

Other trials in Canada

About this study

Official title: TAKE-IT: Teen Adherence in Kidney Transplant Effectiveness of Intervention Trial

The broad aim of the proposed study is to improve medication adherence in adolescent kidney transplant recipients. The investigators hypothesize that a multi-component intervention will improve medication adherence in the adolescent kidney transplant population. The specific aims are to determine, in a randomized clinical trial, the efficacy of a structured, multi-component intervention in improving adherence to anti-rejection medications and graft outcomes, and to identify characteristics of healthcare systems that are independently associated with adherence.

Read the detailed description

Young kidney transplant recipients at 8 pediatric transplant centers in the United States and Canada will be invited to participate. Participants will be randomly assigned to either the control or intervention group. Adherence will be measured in all participants using an electronic medication monitoring multi-dose pillbox. Enrolment will be followed by a 3-month run-in period, during which group allocation will be concealed and no intervention administered. At the 3-month visit, participants assigned to the intervention group will form an Adherence Support Team including the participant, one or both parents, and a study facilitator who is not a member of the treating team. At the same visit the facilitator will provide standardized adherence education, and will initiate a novel 20-30 min. behavioural intervention, which combines problem-solving skills with implementation intentions (concrete action plans in which an individual specifies, in an if-then contingency format, when, where and how he or she will perform a behaviour, with the goal of developing habits). This intervention will focus on addressing adherence barriers identified using the validated Medication Barriers Survey 3 and selected by the participant as important to him or her. Subsequent study visits, at 3-month intervals, will include a briefer versions of the educational component, and review and updating of implementation intentions. In addition, the electronic pillbox will be configured to provide alarm, phone, or text message dose reminders to participants in the intervention group throughout the intervention interval. Control participants will also meet with the facilitator at 3-month intervals, but will simply discuss general health and life issues; they will not receive dose reminders. In between visits, the facilitator will maintain monthly contact with all participants via short phone or text-message check-ins to troubleshoot issues with the electronic pillbox. The primary outcome will be 'taking adherence' - the proportion of prescribed doses that were consumed. Appropriate timing of doses will also be evaluated, as will variability in medication levels (reflecting consistency of medication consumption), and graft outcomes. Level of adherence, patterns of change in adherence, and graft outcomes will be compared between intervention and control groups. Secondary observational analyses of collected study data will identify healthcare systems factors independently associated with adherence.

Being tested
Action-focused problem-solving, Electronic pillbox monitoring, dose reminders, and feedback
Keywords
renal, allograft, immunosuppressive, immunosuppression, adherence, medication, compliance
Medical subject headings
Medication Adherence, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Action-focused problem-solvingBehavioural

    • Adherence Support Team (patient, parent, Coach)
    • standardized education on immunosuppressive medications
    • identification of adherence barriers
    • 'Action-Focused Problem-Solving' to address barriers selected as most important by the patient

  • Electronic pillbox monitoring, dose reminders, and feedbackDevice

    Also called Medminder Systems, Maya, US Patent Number 5710551, Vaica Medical

    • Electronic adherence monitoring with feedback of past 3 months of electronic monitoring data at 3-month intervals
    • text message, email, or visual cue dose reminders
Study groups in NCT01356277
Study groupRoleWhat they receive
Multi-component InterventionExperimentalMulti-component Intervention consisting of: * Adherence Support Team (patient, parent, Coach) * standardized education on immunosuppressive medications * identification of adherence barriers * Electronic adherence monitoring with feedback of past 3 months of electronic monitoring data at 3-month intervals * 'Action-Focused Problem-Solving' to address barriers selected as most important by the patient * text message, email, or visual cue dose reminders
Receives: Behavioral: Action-focused problem-solving; Device: Electronic pillbox monitoring, dose reminders, and feedback
Attention controlNo interventionControl group study visits were conducted at the same intervals as intervention visits and consisted of the Coach engaging in active listening and providing non-specific support only. Adherence was NOT discussed with control participants.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Taking Adherence

    Daily "taking adherence", defined as the 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 had 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 (due to travel etc), no score was given.

    To summarize adherence for each arm, we calculated the total percentage of days of observation for which there was 100% taking adherence. The denominator for this calculation was the the total number of days of observation of each participant, summed across all participants; the numerator was the total number of days of observation of each participant for which taking adherence was 100%, summed across all participants.

    Measured: 12 months

  2. Timing Adherence

    Daily "timing adherence", defined as the percentage of doses taken within 1 hour 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 had 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 (due to travel etc), no score was given.

    To summarize timing adherence for each arm, we calculated the total percentage of days of observation for which there was 100% timing adherence. The denominator for this calculation was the the total number of days of observation of each participant, summed across all participants; the numerator was the total number of days of observation of each participant for which timing adherence was 100%, summed across all participants.

    Measured: 12 months

Secondary outcomes (5)

  1. Standard Deviation (SD) of Tacrolimus Trough Levels

    The SD of all tacrolimus trough levels done for clinical care (except during hospitalizations or illnesses) were calculated for participants with >=3 tacrolimus levels.

    Measured: 12 months

  2. Self-reported Taking Adherence

    Self-reported taking adherence, assessed using the Medical Adherence Measure- Medication Module (MAM-MM), was scored as the proportion of doses taken in the previous week. MAM-MM scores for each patient were summarized as the mean of the four scores post-intervention.

    Measured: 12 months

  3. Self-reported Timing Adherence

    Self-reported timing adherence, assessed using the Medical Adherence Measure- Medication Module (MAM-MM), was scored as the proportion of doses taken up to 2 hours after the prescribed time in the previous week. MAM-MM scores for each patient were summarized as the mean of the four scores post-intervention.

    Measured: 12 months

  4. Acute Rejection Rate

    The acute rejection rate, measured as rejections per 100 person-years of observation.

    Measured: 12 months

  5. Annualized Change in Estimated Glomerular Filtration Rate (eGFR)

    Change in estimated glomerular filtration rate, estimated using the Schwartz equation for those < 18 y. and the CKD-EPI equation for those 18y and older, standardized to a 12-month period.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2011 (estimated)
  2. Study startFeb 2012
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01356277
Sponsor's protocol ID
R01DK092977-01
Acronym
TAKE-IT
Status last verified
Jun 2018
First submitted
17 May 2011
Last updated
18 Jul 2018
Data monitoring committee
Yes

Publications

  • Foster BJ, Pai A, Zhao H, Furth S; TAKE-IT Study Group. The TAKE-IT study: aims, design, and methods. BMC Nephrol. 2014 Aug 30;15:139. doi: 10.1186/1471-2369-15-139.

    PubMed 25176317

  • 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.

    PubMed 36094829

  • Boucquemont J, Pai ALH, Dharnidharka VR, Hebert D, Zelikovsky N, Amaral S, Furth SL, Foster BJ. Association between day of the week and medication adherence among adolescent and young adult kidney transplant recipients. Am J Transplant. 2020 Jan;20(1):274-281. doi: 10.1111/ajt.15590. Epub 2019 Oct 12.

    PubMed 31507087

  • Boucquemont J, Pai ALH, Dharnidharka VR, Hebert D, Furth SL, Foster BJ. Gender Differences in Medication Adherence Among Adolescent and Young Adult Kidney Transplant Recipients. Transplantation. 2019 Apr;103(4):798-806. doi: 10.1097/TP.0000000000002359.

    PubMed 29994983

  • Foster BJ, Pai ALH, Zelikovsky N, Amaral S, Bell L, Dharnidharka VR, Hebert D, Holly C, Knauper B, Matsell D, Phan V, Rogers R, Smith JM, Zhao H, Furth SL. A Randomized Trial of a Multicomponent Intervention to Promote Medication Adherence: The Teen Adherence in Kidney Transplant Effectiveness of Intervention Trial (TAKE-IT). Am J Kidney Dis. 2018 Jul;72(1):30-41. doi: 10.1053/j.ajkd.2017.12.012. Epub 2018 Mar 27.

    PubMed 29602631

Questions about this trial

What is this clinical trial studying?

A study testing Action-focused problem-solving and Electronic pillbox monitoring, dose reminders, and feedback in people with Kidney Transplantation and Medication Adherence, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Taking Adherence (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01356277, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.

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