The TAKE-IT study: aims, design, and methods

BMC Nephrology

Susan Furth²  Huaqing Zhao³  Ahna Pai¹  Bethany J Foster⁴ 

[1] Department of Pediatrics, Cincinnati Children’s Hospital Medical Center, 240 Albert Sabin Way, MLC 7039 S.9552, Cincinnati, OH 45229, USA;Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA;Department of Clinical Sciences, Temple University School of Medicine, MERB 955, 3500 N. Broad St., Philadelphia, PA 19140, USA;Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada

关键词: Kidney transplantation;    Intervention;    Adolescent;    Randomized trial;    Adherence;   

Others  :  1082634
DOI  :  10.1186/1471-2369-15-139

 received in 2014-07-21, accepted in 2014-08-21,  发布年份 2014

【 摘 要 】

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 registrationNCT01356277 (May 17, 2011).

【 授权许可】

   
2014 Foster et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

Figure 3.

Figure 4.

【 参考文献 】

• [1]Arnett JJ: Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol 2000, 55:469-480.
• [2]Foster BJ, Dahhou M, Zhang X, Platt RW, Samuel SM, Hanley JA: Association between age and graft failure rates in young kidney transplant recipients. Transplantation 2011, 92:1237-1243.
• [3]Dobbels F, Ruppar T, De Geest S, Decorte A, Van Damme-Lombaerts R, Fine RN: Adherence to the immunosuppressive regimen in pediatric kidney transplant recipients: a systematic review. Pediatr Transplant 2010, 14:603-613.
• [4]Dew MA, Dabbs AD, Myaskovsky L, Shyu S, Shellmer DA, DiMartini AF, Steel J, Unruh M, Switzer GE, Shapiro R, Greenhouse JB: Meta-analysis of medical regimen adherence outcomes in pediatric solid organ transplantation. Transplantation 2009, 88:736-746.
• [5]Pinsky BW, Takemoto SK, Lentine KL, Burroughs TE, Schnitzler MA, Salvalaggio PR: Transplant outcomes and economic costs associated with patient noncompliance to immunosuppression. Am J Transplant 2009, 9:2597-2606.
• [6]Chisholm-Burns MA, Spivey CA, Rehfeld R, Zawaideh M, Roe DJ, Gruessner R: Immunosuppressant therapy adherence and graft failure among pediatric renal transplant recipients. Am J Transplant 2009, 9:2497-2504.
• [7]Denhaerynck K, Steiger J, Bock A, Schafer-Keller P, Kofer S, Thannberger N, De Geest S: Prevalence and risk factors of non-adherence with immunosuppressive medication in kidney transplant patients. Am J Transplant 2007, 7:108-116.
• [8]Fine RN, Becker Y, De Geest S, Eisen H, Ettenger R, Evans R, Rudow DL, McKay D, Neu A, Nevins T, Reyes J, Wray J, Dobbels F: Nonadherence consensus conference summary report. Am J Transplant 2009, 9:35-41.
• [9]Griva K, Davenport A, Harrison M, Newman SP: Non-adherence to immunosuppressive medications in kidney transplantation: intent vs. forgetfulness and clinical markers of medication intake. Ann Behav Med 2012, 44:85-93.
• [10]Zelikovsky N, Schast AP, Palmer J, Meyers KE: Perceived barriers to adherence among adolescent renal transplant candidates. Pediatr Transplant 2008, 12:300-308.
• [11]Simons LE, McCormick ML, Mee LL, Blount RL: Parent and patient perspectives on barriers to medication adherence in adolescent transplant recipients. Pediatr Transplant 2009, 13:338-347.
• [12]De Bleser L, Matteson M, Dobbels F, Russell C, De Geest S: Interventions to improve medication-adherence after transplantation: a systematic review. Transpl Int 2009, 22:780-797.
• [13]Bonner S, Zimmerman BJ, Evans D, Irigoyen M, Resnick D, Mellins RB: An individualized intervention to improve asthma management among urban Latino and African-American families. J Asthma 2002, 39:167-179.
• [14]Rapoff MA, Belmont J, Lindsley C, Olson N, Morris J, Padur J: Prevention of nonadherence to nonsteroidal anti-inflammatory medications for newly diagnosed patients with juvenile rheumatoid arthritis. Health Psychol 2002, 21:620-623.
• [15]Nansel TR, Iannotti RJ, Simons-Morton BG, Plotnick LP, Clark LM, Zeitzoff L: Long-term maintenance of treatment outcomes: diabetes personal trainer intervention for youth with type 1 diabetes. Diabetes Care 2009, 32:807-809.
• [16]Miloh T, Annunziato R, Arnon R, Warshaw J, Parkar S, Suchy FJ, Iyer K, Kerkar N: Improved adherence and outcomes for pediatric liver transplant recipients by using text messaging. Pediatrics 2009, 124:e844-e850.
• [17]Chisholm-Burns MA, Spivey CA, Graff Zivin J, Lee JK, Sredzinski E, Tolley EA: Improving outcomes of renal transplant recipients with behavioral adherence contracts: a randomized controlled trial. Am J Transplant 2013, 13:2364-2373.
• [18]Ingerski L, Perrazo L, Goebel J, Pai AL: Family strategies for achieving medication adherence in pediatric kidney transplantation. Nurs Res 2011, 60:190-196.
• [19]Simons LE, Blount RL: Identifying barriers to medication adherence in adolescent transplant recipients. J Pediatr Psychol 2007, 32:831-844.
• [20]Pai AL, Gray E, Kurivial K, Ross J, Schoborg D, Goebel J: The Allocation of Treatment Responsibility scale: a novel tool for assessing patient and caregiver management of pediatric medical treatment regimens. Pediatr Transplant 2010. in press
• [21]Zelikovsky N, Schast AP: Eliciting accurate reports of adherence in a clinical interview: development of the Medical Adherence Measure. Pediatr Nurs 2008, 34:141-146.
• [22]Varni JW: Linguistic Validation of the PedsQL. Lyon, France: Mapi Research Institute; 2002. accessed at: http://www.pedsql.org/translations.html webcite on Feb. 24, 2013
• [23]Schafer-Keller P, Steiger J, Bock A, Denhaerynck K, De Geest S: Diagnostic accuracy of measurement methods to assess non-adherence to immunosuppressive drugs in kidney transplant recipients. Am J Transplant 2008, 8:616-626.
• [24]D’Zurilla TJ, Goldfried MR: Problem solving and behavior modification. J Abnorm Psychol 1971, 78:107-126.
• [25]D’Zurilla TJ, Nezu AM: Problem-Solving Therapy a Positive Approach to Clinical Intervention. New York: Springer Publishing; 2007.
• [26]Laffel LM, Vangsness L, Connell A, Goebel-Fabbri A, Butler D, Anderson BJ: Impact of ambulatory, family-focused teamwork intervention on glycemic control in youth with type 1 diabetes. J Pediatr 2003, 142:409-416.
• [27]Quittner AL, Drotar D, Ievers-Landis C, Seidner D, Slocum N, Jacobson J: Adherence to medical treatments in adolescents with cystic fibrosis: The development and evalutation of family-based interventions. In Promoting Adherence to Medical Treatment in Childhood Chronic Illness: Concepts, Methods, and Interventions. Edited by Drotar D. Mahwah, N.J: Lawrene Erlbaum Associates; 2000:383-361.
• [28]Safren SA, O’Cleirigh C, Tan J, Raminani S, Reilly LC, Otto MW, Mayer KH: Randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in HIV-infected individuals. Health Psychol 2009, 28:1-10.
• [29]Seid M, Varni JW, Gidwani P, Gelhard LR, Slymen DJ: Problem-solving skills training for vulnerable families of children with persistent asthma: Report of a randomized trial on health-related quality of life outcomes. J Pediatr Psychol 2010, 35:1133-1143.
• [30]Wysocki T, Harris MA, Buckloh LM, Mertlich D, Lochrie AS, Taylor A, Sadler M, White NH: Randomized, controlled trial of behavioral family systems therapy for diabetes: maintenance and generalization of effects on parent-adolescent communication. Behav Ther 2008, 39:33-46.
• [31]Brown I, Sheeran P, Reuber M: Enhancing antiepileptic drug adherence: a randomized controlled trial. Epilepsy Behav 2009, 16:634-639.
• [32]Knauper B, Roseman M, Johnson PJ, Krantz L: Using mental imagery to enhance the effectiveness of implementation intentions. Curr Psychol 2009, 28:181-186.
• [33]Gollwitzer PM: Implementation intentions: Strong effects of simple plans. Am Psychol 1999, 54:493-503.
• [34]Webb TL, Sheeran P: Identifying good opportunities to act: implementation intentions and cue discrimination. Eur J Soc Psychol 2004, 34:407-419.
• [35]Demonceau J, Ruppar T, Kristanto P, Hughes DA, Fargher E, Kardas P, De Geest S, Dobbels F, Lewek P, Urquhart J, Vrijens B: Identification and assessment of adherence-enhancing interventions in studies assessing medication adherence through electronically compiled drug dosing histories: a systematic literature review and meta-analysis. Drugs 2013, 73:545-562.
• [36]Hsiau M, Fernandez HE, Gjertson D, Ettenger RB, Tsai EW: Monitoring nonadherence and acute rejection with variation in blood immunosuppressant levels in pediatric renal transplantation. Transplantation 2011, 92:918-922.
• [37]Pollock-Barziv SM, Finkelstein Y, Manlhiot C, Dipchand AI, Hebert D, Ng VL, Solomon M, McCrindle BW, Grant D: Variability in tacrolimus blood levels increases the risk of late rejection and graft loss after solid organ transplantation in older children. Pediatr Transplant 2010, 14:968-975.
• [38]Shemesh E, Shneider BL, Savitzky JK, Arnott L, Gondolesi GE, Krieger NR, Kerkar N, Magid MS, Stuber ML, Schmeidler J, Yehuda R, Emre S: Medication adherence in pediatric and adolescent liver transplant recipients. Pediatrics 2004, 113:825-832.
• [39]Pai AL, Rausch J, Tackett A, Marsolo K, Drotar D, Goebel J: System for integrated adherence monitoring: real-time non-adherence risk assessment in pediatric kidney transplantation. Pediatr Transplant 2012, 16:329-334.
• [40]Schwartz GJ, Work DF: Measurement and estimation of GFR in children and adolescents. Clin J Am Soc Nephrol 2009, 4:1832-1843.
• [41]Staples A, LeBlond R, Watkins S, Wong C, Brandt J: Validation of the revised Schwartz estimating equation in a predominantly non-CKD population. Pediatr Nephrol 2010, 25:2321-2326.
• [42]Berben L, Dobbels F, Engberg S, Hill MN, De Geest S: An ecological perspective on medication adherence. West J Nurs Res 2012, 34:635-653.
• [43]Haas JS, Phillips KA, Sonneborn D, McCulloch CE, Baker LC, Kaplan CP, Perez , Stable EJ, Liang SY: Variation in access to health care for different racial/ethnic groups by the racial/ethnic composition of an individual’s county of residence. Med Care 2004, 42:707-714.
• [44]Federico SG, Steiner JF, Beaty B, Crane L, Kempe A: Disruptions in insurance coverage: patterns and relationship to health care access, unmet need, and utilization before enrollment in the State Children’s Health Insurance Program. Pediatrics 2007, 120:e1009-e1016.
• [45]Modi AC, Rausch JR, Glauser TA: Patterns of nonadherence to antiepileptic drug therapy in children with newly diagnosed epilepsy. JAMA 2011, 305:1669-1676.
• [46]Klein A, Otto G, Kramer I: Impact of a pharmaceutical care program on liver transplant patients’ compliance with immunosuppressive medication: a prospective, randomized, controlled trial using electronic monitoring. Transplantation 2009, 87:839-847.
• [47]Dejean NB, Rontaing L, Lapeyre-Mestre M, Roge B, Durand D: Educational Program to Reduce Noncompliance after Renal Transplantation. In European Renal Association and European Dialysis and Transplantation Association. Lisbon, Portugal; 2004.
• [48]Fennell RS, Foulkes LM, Boggs SR: Family-based program to promote medication compliance in renal transplant children. Transplant Proc 1994, 26:102-103.
• [49]De Geest S, Schafer-Keller P, Denhaerynck K, Thannberger N, Kofer S, Bock A, Surber C, Steiger J: Supporting medication adherence in renal transplantation (SMART): a pilot RCT to improve adherence to immunosuppressive regimens. Clin Transplant 2006, 20:359-368.
• [50]Russell C, Conn V, Ashbaugh C, Madsen R, Wakefield M, Webb A, Coffey D, Peace L: Taking immunosuppressive medications effectively (TIMELink): a pilot randomized controlled trial in adult kidney transplant recipients. Clin Transplant 2011, 25:864-870.