Study Summary
This trial is testing whether monetary incentives can improve medication adherence in patients with familial hypercholesterolemia, a genetic disorder that greatly increases the risk of heart disease.
Eligible Conditions
- High Cholesterol
- Medication Adherence
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
3 Primary · 0 Secondary · Reporting Duration: Days 75-134
Day 0
1.1: Baseline adherence level
Days 14-74
1.2: Change in adherence with monetary incentives
Days 75-134
1.3: Change in adherence withOUT monetary incentives
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
1 Treatment Group
Interventions
1 of 1
Experimental Treatment
30 Total Participants · 1 Treatment Group
Primary Treatment: Monetary incentives · No Placebo Group · N/A
Interventions
Behavioral
Experimental Group · 1 Intervention: Monetary incentives · Intervention Types: BehavioralTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Monetary incentives
2015
N/A
~70
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: days 75-134
Who is running the clinical trial?
MMAS Research LLCUNKNOWN
Boston Children's HospitalLead Sponsor
726 Previous Clinical Trials
5,432,024 Total Patients Enrolled
Wellth Inc.Industry Sponsor
5 Previous Clinical Trials
618 Total Patients Enrolled
MMAS-8 with permission from Dr Donald Morisky. as written belowUNKNOWN
Eligibility Criteria
Age 12 - 21 · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are taking a medication called a statin.
You have a history of not taking your medication as directed.
References
- Burton, Wayne N., Chin-Yu Chen, Alyssa B. Schultz, and Dee W. Edington. 2010. “The Association Between Achieving Low-density Lipoprotein Cholesterol (LDL-C) Goal and Statin Treatment in an Employee Population”. Population Health Management. Mary Ann Liebert Inc. doi:10.1089/pop.2009.0020.
- Pittman, Donald G., William Chen, Steven J. Bowlin, and JoAnne M. Foody. 2011. “Adherence to Statins, Subsequent Healthcare Costs, and Cardiovascular Hospitalizations”. The American Journal of Cardiology. Elsevier BV. doi:10.1016/j.amjcard.2011.01.052.
- Braamskamp, Marjet J. A. M., D. Meeike Kusters, Hans J. Avis, Ellen M. A. Smets, Frits A. Wijburg, John J. P. Kastelein, Albert Wiegman, and Barbara A. Hutten. 2015. “Long-term Statin Treatment in Children with Familial Hypercholesterolemia: More Insight into Tolerability and Adherence”. Pediatric Drugs. Springer Science and Business Media LLC. doi:10.1007/s40272-014-0116-y.
- de Jongh, Saskia, Leiv Ose, Tamás Szamosi, Claude Gagné, M. Lambert, Russell Scott, P. Perron, et al.. 2002. “Efficacy and Safety of Statin Therapy in Children with Familial Hypercholesterolemia”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/01.cir.0000035247.42888.82.
- Nawrocki, James W., Stuart R. Weiss, Michael H. Davidson, Dennis L. Sprecher, Sherwyn L. Schwartz, Paul-J. Lupien, Peter H. Jones, Harry E. Haber, and Donald M. Black. 1995. “Reduction of LDL Cholesterol by 25% to 60% in Patients with Primary Hypercholesterolemia by Atorvastatin, a New Hmg-coa Reductase Inhibitor”. Arteriosclerosis, Thrombosis, and Vascular Biology. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/01.atv.15.5.678.
- Rodenburg, Jessica, Maud N. Vissers, Albert Wiegman, A. S. Paul van Trotsenburg, Anouk van der Graaf, Eric de Groot, Frits A. Wijburg, John J.P. Kastelein, and Barbara A. Hutten. 2007. “Statin Treatment in Children with Familial Hypercholesterolemia”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.106.671016.
- Lynagh, Marita C., Rob W. Sanson-Fisher, and Billie Bonevski. 2011. “What’s Good for the Goose Is Good for the Gander. Guiding Principles for the Use of Financial Incentives in Health Behaviour Change”. International Journal of Behavioral Medicine. Springer Science and Business Media LLC. doi:10.1007/s12529-011-9202-5.
- Wei, L. 2002. “Adherence to Statin Treatment and Readmission of Patients After Myocardial Infarction: A Six Year Follow up Study”. Heart. BMJ. doi:10.1136/heart.88.3.229.
- Halpern, Scott D., Benjamin French, Dylan S. Small, Kathryn Saulsgiver, Michael O. Harhay, Janet Audrain-McGovern, George Loewenstein, Troyen A. Brennan, David A. Asch, and Kevin G. Volpp. 2015. “Randomized Trial of Four Financial-incentive Programs for Smoking Cessation”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1414293.
- Baranowski, Tom, Karen Weber Cullen, Karen Basen-Engquist, David W. Wetter, Scott Cummings, Daniel S. Martineau, Alexander V. Prokhorov, Joe Chorley, Bettina Beech, and Albert C. Hergenroeder. 1997. “Transitions Out of High School: Time of Increased Cancer Risk?”. Preventive Medicine. Elsevier BV. doi:10.1006/pmed.1997.0193.
- Neil, A., J. Cooper, J. Betteridge, N. Capps, I. McDowell, P. Durrington, M. Seed, S. E. Humphries, and on behalf of the Simon Broome Familial Hyperlipidaemia Register Group. 2008. “Reductions in All-cause, Cancer, and Coronary Mortality in Statin-treated Patients with Heterozygous Familial Hypercholesterolaemia: A Prospective Registry Study”. European Heart Journal. Oxford University Press (OUP). doi:10.1093/eurheartj/ehn422.
- Wiegman, Albert, Samuel S. Gidding, Gerald F. Watts, M. John Chapman, Henry N. Ginsberg, Marina Cuchel, Leiv Ose, et al.. 2015. “Familial Hypercholesterolaemia in Children and Adolescents: Gaining Decades of Life by Optimizing Detection and Treatment”. European Heart Journal. Oxford University Press (OUP). doi:10.1093/eurheartj/ehv157.
- Wiegman, Albert, Barbara A. Hutten, Eric de Groot, Jessica Rodenburg, Henk D. Bakker, Harry R. Büller, Eric J. G. Sijbrands, and John J. P. Kastelein. 2004. “Efficacy and Safety of Statin Therapy in Children with Familial Hypercholesterolemia”. Jama. American Medical Association (AMA). doi:10.1001/jama.292.3.331.
- Falkenstein, Kathleen, Louise Flynn, Beverly Kirkpatrick, Adela Casa-Melley, and Stephen Dunn. 2004. “Non-compliance in Children Post-liver Transplant. Who Are the Culprits?”. Pediatric Transplantation. Wiley. doi:10.1111/j.1399-3046.2004.00136.x.
- Mulvaney, Shelagh, and Joyce M. Lee. 2017. “Motivating Health Behaviors in Adolescents Through Behavioral Economics”. JAMA Pediatrics. American Medical Association (AMA). doi:10.1001/jamapediatrics.2017.3464.
- Blakemore, Sarah-Jayne, and Trevor W Robbins. 2012. “Decision-making in the Adolescent Brain”. Nature Neuroscience. Springer Science and Business Media LLC. doi:10.1038/nn.3177.
- van Driel ML, Morledge MD, Ulep R, Shaffer JP, Davies P, Deichmann R. Interventions to improve adherence to lipid-lowering medication. Cochrane Database Syst Rev. 2016 Dec 21;12:CD004371. doi: 10.1002/14651858.CD004371.pub4. Review.
- Molfenter, Todd, Bhattacharya, and Gustafson. 2012. “The Roles of Past Behavior and Health Beliefs in Predicting Medication Adherence to a Statin Regimen”. Patient Preference and Adherence. Informa UK Limited. doi:10.2147/ppa.s34711.
- Kavey, Rae-Ellen W., Vivek Allada, Stephen R. Daniels, Laura L. Hayman, Brian W. McCrindle, Jane W. Newburger, Rulan S. Parekh, and Julia Steinberger. 2006. “Cardiovascular Risk Reduction in High-risk Pediatric Patients”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.106.179568.
- De Vera, Mary A., Vidula Bhole, Lindsay C. Burns, and Diane Lacaille. 2014. “Impact of Statin Adherence on Cardiovascular Disease and Mortality Outcomes: A Systematic Review”. British Journal of Clinical Pharmacology. Wiley. doi:10.1111/bcp.12339.
- Normansell R, Kew KM, Stovold E. Interventions to improve adherence to inhaled steroids for asthma. Cochrane Database Syst Rev. 2017 Apr 18;4:CD012226. doi: 10.1002/14651858.CD012226.pub2. Review.
- Burke, Lora E., Jun Ma, Kristen M.J. Azar, Gary G. Bennett, Eric D. Peterson, Yaguang Zheng, William Riley, et al.. 2015. “Current Science on Consumer Use of Mobile Health for Cardiovascular Disease Prevention”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/cir.0000000000000232.
- “Efficacy and Safety of Cholesterol-lowering Treatment: Prospective Meta-analysis of Data from 90 056 Participants in 14 Randomised Trials of Statins”. 2005. “Efficacy and Safety of Cholesterol-lowering Treatment: Prospective Meta-analysis of Data from 90 056 Participants in 14 Randomised Trials of Statins”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(05)67394-1.
- Braamskamp, Marjet J.A.M., Gisle Langslet, Brian W. McCrindle, David Cassiman, Gordon A. Francis, Claude Gagné, Daniel Gaudet, et al.. 2015. “Efficacy and Safety of Rosuvastatin Therapy in Children and Adolescents with Familial Hypercholesterolemia: Results from the CHARON Study”. Journal of Clinical Lipidology. Elsevier BV. doi:10.1016/j.jacl.2015.07.011.
- Gatwood, Justin, and James Bailey. 2014. “Improving Medication Adherence in Hypercholesterolemia: Challenges and Solutions”. Vascular Health and Risk Management. Informa UK Limited. doi:10.2147/vhrm.s56056.
- Telama, Risto, Xiaolin Yang, Jorma Viikari, Ilkka Välimäki, Olli Wanne, and Olli Raitakari. 2005. “Physical Activity from Childhood to Adulthood”. American Journal of Preventive Medicine. Elsevier BV. doi:10.1016/j.amepre.2004.12.003.
- Gidding, Samuel S., Mary Ann Champagne, Sarah D. de Ferranti, Joep Defesche, Matthew K. Ito, Joshua W. Knowles, Brian McCrindle, et al.. 2015. “The Agenda for Familial Hypercholesterolemia”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/cir.0000000000000297.
- Jacobson, Terry A., Kevin C. Maki, Carl E. Orringer, Peter H. Jones, Penny Kris-Etherton, Geeta Sikand, Ralph La Forge, et al.. 2015. “National Lipid Association Recommendations for Patient-centered Management of Dyslipidemia: Part 2”. Journal of Clinical Lipidology. Elsevier BV. doi:10.1016/j.jacl.2015.09.002.
- Rausch, Joseph R., Korey K. Hood, Alan Delamater, Jennifer Shroff Pendley, Jennifer M. Rohan, Grafton Reeves, Lawrence Dolan, and Dennis Drotar. 2012. “Changes in Treatment Adherence and Glycemic Control During the Transition to Adolescence in Type 1 Diabetes”. Diabetes Care. American Diabetes Association. doi:10.2337/dc11-2163.
- Badawy, Sherif M, and Lisa M Kuhns. 2017. “Texting and Mobile Phone App Interventions for Improving Adherence to Preventive Behavior in Adolescents: A Systematic Review”. JMIR Mhealth and Uhealth. JMIR Publications Inc.. doi:10.2196/mhealth.6837.
- Meredith, Steven, Brantley Jarvis, Bethany Raiff, Alana Rojewski, Rachel Cassidy, Philip Erb, Jolene Sy, Jesse Dallery, and Allison Kurti. 2014. “The Abcs of Incentive-based Treatment in Health Care: A Behavior Analytic Framework to Inform Research and Practice”. Psychology Research and Behavior Management. Informa UK Limited. doi:10.2147/prbm.s59792.
- Sen, Aditi P., Taylor B. Sewell, E. Brooks Riley, Beth Stearman, Scarlett L. Bellamy, Michelle F. Hu, Yuanyuan Tao, et al.. 2014. “Financial Incentives for Home-based Health Monitoring: A Randomized Controlled Trial”. Journal of General Internal Medicine. Springer Science and Business Media LLC. doi:10.1007/s11606-014-2778-0.
- “Risk of Fatal Coronary Heart Disease in Familial Hypercholesterolaemia. Scientific Steering Committee on Behalf of the Simon Broome Register Group.”. 1991. “Risk of Fatal Coronary Heart Disease in Familial Hypercholesterolaemia. Scientific Steering Committee on Behalf of the Simon Broome Register Group.”. Bmj. BMJ. doi:10.1136/bmj.303.6807.893.
- Marcano Belisario JS, Huckvale K, Greenfield G, Car J, Gunn LH. Smartphone and tablet self management apps for asthma. Cochrane Database Syst Rev. 2013 Nov 27;(11):CD010013. doi: 10.1002/14651858.CD010013.pub2. Review.
- Sardi, Lamyae, Ali Idri, and José Luis Fernández-Alemán. 2017. “A Systematic Review of Gamification in E-health”. Journal of Biomedical Informatics. Elsevier BV. doi:10.1016/j.jbi.2017.05.011.
- Braamskamp, Marjet J.A.M., John J.P. Kastelein, D. Meeike Kusters, Barbara A. Hutten, and Albert Wiegman. 2016. “Statin Initiation During Childhood in Patients with Familial Hypercholesterolemia”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2015.11.021.
- Fung, Vicki, Ilana Graetz, Mary Reed, and Marc G. Jaffe. 2018. “Patient-reported Adherence to Statin Therapy, Barriers to Adherence, and Perceptions of Cardiovascular Risk”. Edited by Katriina Aalto-Setala. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0191817.
- Joyce, Nina R., Gregory A. Wellenius, Charles B. Eaton, Amal N. Trivedi, and Justin P. Zachariah. 2016. “Patterns and Predictors of Medication Adherence to Lipid-lowering Therapy in Children Aged 8 to 20 Years”. Journal of Clinical Lipidology. Elsevier BV. doi:10.1016/j.jacl.2016.03.002.
- Osterberg, Lars, and Terrence Blaschke. 2005. “Adherence to Medication”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmra050100.
- Taddeo, Danielle, Maud Egedy, and Jean-Yves Frappier. 2008. “Adherence to Treatment in Adolescents”. Paediatrics & Child Health. Oxford University Press (OUP). doi:10.1093/pch/13.1.19.
- Patel, Mitesh S., David A. Asch, Roy Rosin, Dylan S. Small, Scarlett L. Bellamy, Jack Heuer, Susan Sproat, et al.. 2016. “Framing Financial Incentives to Increase Physical Activity Among Overweight and Obese Adults”. Annals of Internal Medicine. American College of Physicians. doi:10.7326/m15-1635.
- Bénabou R and Tirole J. Intrinsic and extrinsic motivation. Review of Economic Studies. 2003;30:489-520.
- 1. National Institute for Health and Clinical Excellence. Statins for the prevention of cardiovascular events. Technology Appraisal. London: National Institute for Health and Clinical Excellence, 2006.
- Pew Research Internet Project: cell phone and smartphone ownership demographics. 2014. http://www.pewinternet.org/data-trend/mobile/cell-phone-and-smartphone-ownership-demographics. Accessed January 22, 2018.
- Jacobson, Terry A., Kevin C. Maki, Carl E. Orringer, Peter H. Jones, Penny Kris-Etherton, Geeta Sikand, Ralph La Forge, et al.. 2015. “National Lipid Association Recommendations for Patient-centered Management of Dyslipidemia: Part 2”. Journal of Clinical Lipidology. Elsevier BV. doi:10.1016/j.jacl.2015.09.002.
- O'Donoghue T and Rabin M. Doing it now or later. Am Econ Rev. 1999;89:103-124.
- Gächter S, Orzen H, Renner E and Starmer C. Are experimental economists prone to framing effects? A natural field experiment. . Journal of Economic Behavior & Organization. 2009;70.
- Sen, Aditi P., Taylor B. Sewell, E. Brooks Riley, Beth Stearman, Scarlett L. Bellamy, Michelle F. Hu, Yuanyuan Tao, et al.. 2014. “Financial Incentives for Home-based Health Monitoring: A Randomized Controlled Trial”. Journal of General Internal Medicine. Springer Science and Business Media LLC. doi:10.1007/s11606-014-2778-0.
- Riekert K. Promoting Adherence And Increasing Life Span. Johns Hopkins Advanced Studies in Medicine. 2009;9.
- Wiegman A, Gidding SS, Watts GF, Chapman MJ, Ginsberg HN, Cuchel M, Ose L, Averna M, Boileau C, Boren J, Bruckert E, Catapano AL, Defesche JC, Descamps OS, Hegele RA, Hovingh GK, Humphries SE, Kovanen PT, Kuivenhoven JA, Masana L, Nordestgaard BG, Pajukanta P, Parhofer KG, Raal FJ, Ray KK, Santos RD, Stalenhoef AF, Steinhagen-Thiessen E, Stroes ES, Taskinen MR, Tybjaerg-Hansen A, Wiklund O; European Atherosclerosis Society Consensus Panel. Familial hypercholesterolaemia in children and adolescents: gaining decades of life by optimizing detection and treatment. Eur Heart J. 2015 Sep 21;36(36):2425-37. doi: 10.1093/eurheartj/ehv157. Epub 2015 May 25.
- Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
- Marcano Belisario JS, Huckvale K, Greenfield G, Car J, Gunn LH. Smartphone and tablet self management apps for asthma. Cochrane Database Syst Rev. 2013 Nov 27;2013(11):CD010013. doi: 10.1002/14651858.CD010013.pub2.
- Wei L, Wang J, Thompson P, Wong S, Struthers AD, MacDonald TM. Adherence to statin treatment and readmission of patients after myocardial infarction: a six year follow up study. Heart. 2002 Sep;88(3):229-33. doi: 10.1136/heart.88.3.229.
- Lynagh MC, Sanson-Fisher RW, Bonevski B. What's good for the goose is good for the gander. Guiding principles for the use of financial incentives in health behaviour change. Int J Behav Med. 2013 Mar;20(1):114-20. doi: 10.1007/s12529-011-9202-5.
- Jacobson TA, Maki KC, Orringer CE, Jones PH, Kris-Etherton P, Sikand G, La Forge R, Daniels SR, Wilson DP, Morris PB, Wild RA, Grundy SM, Daviglus M, Ferdinand KC, Vijayaraghavan K, Deedwania PC, Aberg JA, Liao KP, McKenney JM, Ross JL, Braun LT, Ito MK, Bays HE, Brown WV, Underberg JA; NLA Expert Panel. National Lipid Association Recommendations for Patient-Centered Management of Dyslipidemia: Part 2. J Clin Lipidol. 2015 Nov-Dec;9(6 Suppl):S1-122.e1. doi: 10.1016/j.jacl.2015.09.002. Epub 2015 Sep 18. Erratum In: J Clin Lipidol. 2016 Jan-Feb;10(1):211. Underberg, James A [added].
- Baigent C, Keech A, Kearney PM, Blackwell L, Buck G, Pollicino C, Kirby A, Sourjina T, Peto R, Collins R, Simes R; Cholesterol Treatment Trialists' (CTT) Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005 Oct 8;366(9493):1267-78. doi: 10.1016/S0140-6736(05)67394-1. Epub 2005 Sep 27. Erratum In: Lancet. 2005 Oct 15-21;366(9494):1358. Lancet. 2008 Jun 21;371(9630):2084.
- Blakemore SJ, Robbins TW. Decision-making in the adolescent brain. Nat Neurosci. 2012 Sep;15(9):1184-91. doi: 10.1038/nn.3177. Epub 2012 Aug 28.
- Taddeo D, Egedy M, Frappier JY. Adherence to treatment in adolescents. Paediatr Child Health. 2008 Jan;13(1):19-24. doi: 10.1093/pch/13.1.19.
- Rodenburg J, Vissers MN, Wiegman A, van Trotsenburg AS, van der Graaf A, de Groot E, Wijburg FA, Kastelein JJ, Hutten BA. Statin treatment in children with familial hypercholesterolemia: the younger, the better. Circulation. 2007 Aug 7;116(6):664-8. doi: 10.1161/CIRCULATIONAHA.106.671016. Epub 2007 Jul 30.
- Meredith SE, Jarvis BP, Raiff BR, Rojewski AM, Kurti A, Cassidy RN, Erb P, Sy JR, Dallery J. The ABCs of incentive-based treatment in health care: a behavior analytic framework to inform research and practice. Psychol Res Behav Manag. 2014 Mar 19;7:103-14. doi: 10.2147/PRBM.S59792. eCollection 2014.
- Gidding SS, Champagne MA, de Ferranti SD, Defesche J, Ito MK, Knowles JW, McCrindle B, Raal F, Rader D, Santos RD, Lopes-Virella M, Watts GF, Wierzbicki AS; American Heart Association Atherosclerosis, Hypertension, and Obesity in Young Committee of Council on Cardiovascular Disease in Young, Council on Cardiovascular and Stroke Nursing, Council on Functional Genomics and Translational Biology, and Council on Lifestyle and Cardiometabolic Health. The Agenda for Familial Hypercholesterolemia: A Scientific Statement From the American Heart Association. Circulation. 2015 Dec 1;132(22):2167-92. doi: 10.1161/CIR.0000000000000297. Epub 2015 Oct 28. No abstract available. Erratum In: Circulation. 2015 Dec 22;132(25):e397.
- Sardi L, Idri A, Fernandez-Aleman JL. A systematic review of gamification in e-Health. J Biomed Inform. 2017 Jul;71:31-48. doi: 10.1016/j.jbi.2017.05.011. Epub 2017 May 20.
- Braamskamp MJAM, Langslet G, McCrindle BW, Cassiman D, Francis GA, Gagne C, Gaudet D, Morrison KM, Wiegman A, Turner T, Kusters DM, Miller E, Raichlen JS, Wissmar J, Martin PD, Stein EA, Kastelein JJP. Efficacy and safety of rosuvastatin therapy in children and adolescents with familial hypercholesterolemia: Results from the CHARON study. J Clin Lipidol. 2015 Nov-Dec;9(6):741-750. doi: 10.1016/j.jacl.2015.07.011. Epub 2015 Aug 1.
- Falkenstein K, Flynn L, Kirkpatrick B, Casa-Melley A, Dunn S. Non-compliance in children post-liver transplant. Who are the culprits? Pediatr Transplant. 2004 Jun;8(3):233-6. doi: 10.1111/j.1399-3046.2004.00136.x.
- van Driel ML, Morledge MD, Ulep R, Shaffer JP, Davies P, Deichmann R. Interventions to improve adherence to lipid-lowering medication. Cochrane Database Syst Rev. 2016 Dec 21;12(12):CD004371. doi: 10.1002/14651858.CD004371.pub4.
- Braamskamp MJAM, Kastelein JJP, Kusters DM, Hutten BA, Wiegman A. Statin Initiation During Childhood in Patients With Familial Hypercholesterolemia: Consequences for Cardiovascular Risk. J Am Coll Cardiol. 2016 Feb 2;67(4):455-456. doi: 10.1016/j.jacc.2015.11.021. No abstract available.
- Kavey RE, Allada V, Daniels SR, Hayman LL, McCrindle BW, Newburger JW, Parekh RS, Steinberger J; American Heart Association Expert Panel on Population and Prevention Science; American Heart Association Council on Cardiovascular Disease in the Young; American Heart Association Council on Epidemiology and Prevention; American Heart Association Council on Nutrition, Physical Activity and Metabolism; American Heart Association Council on High Blood Pressure Research; American Heart Association Council on Cardiovascular Nursing; American Heart Association Council on the Kidney in Heart Disease; Interdisciplinary Working Group on Quality of Care and Outcomes Research. Cardiovascular risk reduction in high-risk pediatric patients: a scientific statement from the American Heart Association Expert Panel on Population and Prevention Science; the Councils on Cardiovascular Disease in the Young, Epidemiology and Prevention, Nutrition, Physical Activity and Metabolism, High Blood Pressure Research, Cardiovascular Nursing, and the Kidney in Heart Disease; and the Interdisciplinary Working Group on Quality of Care and Outcomes Research: endorsed by the American Academy of Pediatrics. Circulation. 2006 Dec 12;114(24):2710-38. doi: 10.1161/CIRCULATIONAHA.106.179568. Epub 2006 Nov 27.
- de Jongh S, Ose L, Szamosi T, Gagne C, Lambert M, Scott R, Perron P, Dobbelaere D, Saborio M, Tuohy MB, Stepanavage M, Sapre A, Gumbiner B, Mercuri M, van Trotsenburg AS, Bakker HD, Kastelein JJ; Simvastatin in Children Study Group. Efficacy and safety of statin therapy in children with familial hypercholesterolemia: a randomized, double-blind, placebo-controlled trial with simvastatin. Circulation. 2002 Oct 22;106(17):2231-7. doi: 10.1161/01.cir.0000035247.42888.82.
- Normansell R, Kew KM, Stovold E. Interventions to improve adherence to inhaled steroids for asthma. Cochrane Database Syst Rev. 2017 Apr 18;4(4):CD012226. doi: 10.1002/14651858.CD012226.pub2.
- De Vera MA, Bhole V, Burns LC, Lacaille D. Impact of statin adherence on cardiovascular disease and mortality outcomes: a systematic review. Br J Clin Pharmacol. 2014 Oct;78(4):684-98. doi: 10.1111/bcp.12339.
- Wiegman A, Hutten BA, de Groot E, Rodenburg J, Bakker HD, Buller HR, Sijbrands EJ, Kastelein JJ. Efficacy and safety of statin therapy in children with familial hypercholesterolemia: a randomized controlled trial. JAMA. 2004 Jul 21;292(3):331-7. doi: 10.1001/jama.292.3.331.
- Gatwood J, Bailey JE. Improving medication adherence in hypercholesterolemia: challenges and solutions. Vasc Health Risk Manag. 2014 Nov 6;10:615-25. doi: 10.2147/VHRM.S56056. eCollection 2014.
- Mulvaney S, Lee JM. Motivating Health Behaviors in Adolescents Through Behavioral Economics. JAMA Pediatr. 2017 Dec 1;171(12):1145-1146. doi: 10.1001/jamapediatrics.2017.3464. No abstract available.
- Burke LE, Ma J, Azar KM, Bennett GG, Peterson ED, Zheng Y, Riley W, Stephens J, Shah SH, Suffoletto B, Turan TN, Spring B, Steinberger J, Quinn CC; American Heart Association Publications Committee of the Council on Epidemiology and Prevention, Behavior Change Committee of the Council on Cardiometabolic Health, Council on Cardiovascular and Stroke Nursing, Council on Functional Genomics and Translational Biology, Council on Quality of Care and Outcomes Research, and Stroke Council. Current Science on Consumer Use of Mobile Health for Cardiovascular Disease Prevention: A Scientific Statement From the American Heart Association. Circulation. 2015 Sep 22;132(12):1157-213. doi: 10.1161/CIR.0000000000000232. Epub 2015 Aug 13. No abstract available. Erratum In: Circulation. 2015 Nov 10;132(19):e233.
- Nawrocki JW, Weiss SR, Davidson MH, Sprecher DL, Schwartz SL, Lupien PJ, Jones PH, Haber HE, Black DM. Reduction of LDL cholesterol by 25% to 60% in patients with primary hypercholesterolemia by atorvastatin, a new HMG-CoA reductase inhibitor. Arterioscler Thromb Vasc Biol. 1995 May;15(5):678-82. doi: 10.1161/01.atv.15.5.678.
- Jacob Hartz 2021. "The Use of Mobile Health Technology and Behavioral Economics to Encourage Adherence in Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04458766.
Frequently Asked Questions
How many participants are being accepted for this clinical trial?
"Affirmative, the information found on clinicaltrials.gov verifies that recruitment for this medical experiment is ongoing. This research was initially posted on January 1st 2021 and has been updated as recently as July 7th 2022. The study requires 30 test subjects from a single clinic to participate in it." - Anonymous Online Contributor
Unverified Answer
Is this experiment actively seeking participants?
"Clinicaltrials.gov confirms that this clinical trial is actively searching for participants, with the initial posting on January 1st 2021 and a recent edit made on July 7th 2022." - Anonymous Online Contributor
Unverified Answer
Does the age qualification for this experiment extend to those under 45 years of age?
"As stipulated by the study's selection criteria, participants should fall within a range of 12 and 21 years old." - Anonymous Online Contributor
Unverified Answer
To what extent is participation in this research project open?
"This clinical trial, which is recruiting 30 participants, requires that all applicants have primary hypercholesterolemia and be between the ages of 12 to 21." - Anonymous Online Contributor
Unverified Answer