Intervention to Improve Adherence in Teen Kidney Transplant

NCT ID: NCT01356277

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2016-06-30

Brief 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. 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.

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.

Conditions

Kidney Transplantation; Medication Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Multi-component Intervention

Multi-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

Group Type: EXPERIMENTAL

Action-focused problem-solving

Intervention Type: BEHAVIORAL

• 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 feedback

Intervention Type: DEVICE

• 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

Attention control

Control 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Action-focused problem-solving

• 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

Intervention Type: BEHAVIORAL

Electronic pillbox monitoring, dose reminders, and feedback

• 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

Intervention Type: DEVICE

Other Intervention Names

Medminder Systems; Maya; US Patent Number 5710551; Vaica Medical; SimpleMed medication reminder and dispenser

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: collaborator

Seattle Children's Hospital

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

British Columbia Children's Hospital

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: collaborator

St. Justine's Hospital

OTHER

Sponsor Role: collaborator

Temple University

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Beth Foster

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bethany J Foster, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Montreal Children's Hospital of the MUHC

Susan L Furth, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Seattle Children's Hospital

Seattle, Washington, United States

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

University of Toronto Hospital for Sick Children

Toronto, Ontario, Canada

Montreal Children's Hospital

Montreal, Quebec, Canada

St. Justine's Hospital

Montreal, Quebec, Canada

Countries

United States; Canada

References

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.

Reference Type: BACKGROUND

PMID: 25176317 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36094829 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31507087 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29994983 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29602631 (View on PubMed)

Other Identifiers

R01DK092977-01

Identifier Type: NIH

Identifier Source: org_study_id

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