TY - JOUR
T1 - The TAKE-IT study
T2 - Aims, design, and methods
AU - Foster, Bethany J.
AU - Pai, Ahna
AU - Zhao, Huaqing
AU - Furth, Susan
N1 - Funding Information:
The purpose of this paper is to describe the aims, design, and methods of TAKE-IT, a multicentre, prospective, parallel arm, open-label, randomized controlled trial funded by the American National Institutes of Health, National Institutes of Diabetes, Digestive and Kidney diseases (NIDDK; R01DK092977). The study began in Sept. 2011 and will run until June 2016.
PY - 2014
Y1 - 2014
N2 - Background: Effective interventions to improve immunosuppressive medication adherence among adolescent and young adult kidney transplant recipients are desperately needed. This paper describes the aims, design, and methods of the Teen Adherence in Kidney transplant, Effectiveness of Intervention Trial (TAKE-IT) study. Design and methods: TAKE-IT is a multicentre, prospective, open-label, parallel arm randomized controlled trial that aims to determine the effectiveness of a clinic-based intervention, including educational, organizational, and behavioural components, in improving immunosuppressive medication adherence among adolescent and young adult kidney transplant recipients. Individuals between 11 and 24 years of age who are at least 3 months post-Transplant and followed in one of the eight participating pediatric kidney transplant programs, or their affiliated adult transplant programs are eligible to participate. All participating centers are tertiary care pediatric hospitals in Canada or the United States. Adherence is monitored using an electronic multi-dose pillbox for all participants during a 3-month run-in period, followed by a 12-month intervention interval. The primary outcome is 'taking adherence', defined as the proportion of prescribed doses of immunosuppressive medications that were taken, as measured using electronic monitoring. All participants meet with the study 'Coach' at 3 month intervals. The intervention, administered by trained lay personnel, targets common adherence barriers. In addition to forming an Adherence Support Team, intervention participants identify personal barriers to adherence and use Action-focused problem-solving to address them, have their electronic adherence data fed back to them, and have the option to receive email, text message, or visual cue dose reminders. Participants in the control group meet with the coach but do not receive the other components of the intervention. The study aims to have 75 participants in each group complete the study. Discussion: Since recruitment began in Feb. 2012, 198 adolescents have been approached to participate, of whom 130 have completed a baseline visit. As of March 31, 2014, 125 had been randomized, and 86, 68, 61, and 50 participants had completed 6-month, 9-month, 12-month, and 15-month visits respectively. Trial registration: Clinicaltrials.gov registration NCT01356277 (May 17, 2011).
AB - Background: Effective interventions to improve immunosuppressive medication adherence among adolescent and young adult kidney transplant recipients are desperately needed. This paper describes the aims, design, and methods of the Teen Adherence in Kidney transplant, Effectiveness of Intervention Trial (TAKE-IT) study. Design and methods: TAKE-IT is a multicentre, prospective, open-label, parallel arm randomized controlled trial that aims to determine the effectiveness of a clinic-based intervention, including educational, organizational, and behavioural components, in improving immunosuppressive medication adherence among adolescent and young adult kidney transplant recipients. Individuals between 11 and 24 years of age who are at least 3 months post-Transplant and followed in one of the eight participating pediatric kidney transplant programs, or their affiliated adult transplant programs are eligible to participate. All participating centers are tertiary care pediatric hospitals in Canada or the United States. Adherence is monitored using an electronic multi-dose pillbox for all participants during a 3-month run-in period, followed by a 12-month intervention interval. The primary outcome is 'taking adherence', defined as the proportion of prescribed doses of immunosuppressive medications that were taken, as measured using electronic monitoring. All participants meet with the study 'Coach' at 3 month intervals. The intervention, administered by trained lay personnel, targets common adherence barriers. In addition to forming an Adherence Support Team, intervention participants identify personal barriers to adherence and use Action-focused problem-solving to address them, have their electronic adherence data fed back to them, and have the option to receive email, text message, or visual cue dose reminders. Participants in the control group meet with the coach but do not receive the other components of the intervention. The study aims to have 75 participants in each group complete the study. Discussion: Since recruitment began in Feb. 2012, 198 adolescents have been approached to participate, of whom 130 have completed a baseline visit. As of March 31, 2014, 125 had been randomized, and 86, 68, 61, and 50 participants had completed 6-month, 9-month, 12-month, and 15-month visits respectively. Trial registration: Clinicaltrials.gov registration NCT01356277 (May 17, 2011).
KW - Adherence
KW - Adolescent
KW - Intervention
KW - Kidney transplantation
KW - Randomized trial
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U2 - 10.1186/1471-2369-15-139
DO - 10.1186/1471-2369-15-139
M3 - Article
C2 - 25176317
AN - SCOPUS:84988646753
SN - 1471-2369
VL - 15
JO - BMC Nephrology
JF - BMC Nephrology
IS - 1
M1 - 139
ER -