A Behavioral Economics-Based Telehealth Intervention to Improve Post-MI Medication Adherence
NCT ID: NCT03022266
Last Updated: 2019-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
130 participants
INTERVENTIONAL
2017-02-01
2018-11-14
Brief Summary
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Detailed Description
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In addition to measurement of medication adherence using an EM device, the investigators will measure adherence using the Wellth cell phone app in the intervention arm. Participants in the intervention arm will also be asked to track their medication-taking habits by uploading photos of their medications at the appropriate dosage times using the Wellth app.
Readmissions will be measured using the EMR and by interview to capture events outside the Penn system. Events will be classified according to timing (e.g. 30-day readmission) and cause (e.g. cardiac, all-cause). This study is not designed to detect a statistically significant difference in readmissions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Intervention Arm
Participants receiving the Financial Incentive and Mobile Phone App will be given an smartphone app offering pill reminders and $50/month financial incentives for three months to upload photos of medication each day for 90 days. Medication adherence will be measured via a CleverCap(R) electronic monitoring pillbox.
Financial Incentive and Mobile Phone App
Subjects receiving the Financial Incentive and Mobile Phone App will each participate in a 90-day adherence promotion program. When users first log in to the app, the screen will display an incentive of $150 that participants have earned by enrolling in the program. Participants will be told that each missed medication check-in will result in a $2 deduction from the account before it is paid out. Each $50 portion (minus any penalties) of the $150 incentive will be paid out in 30-day installments by remotely crediting a previously distributed debit card. Adherence will be measured simultaneously by app photos and CleverCap(R) electronic monitoring (EM) devices filled with a 90-day supply of aspirin. Claims data will be analyzed for a 90 day period to account for any hospital admissions.
Usual Care Control Arm
Participants in the usual care control arm will receive the usual education about medications provided by hospital staff. Medication adherence will be measured via a CleverCap(R) electronic monitoring pillbox.
No interventions assigned to this group
Interventions
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Financial Incentive and Mobile Phone App
Subjects receiving the Financial Incentive and Mobile Phone App will each participate in a 90-day adherence promotion program. When users first log in to the app, the screen will display an incentive of $150 that participants have earned by enrolling in the program. Participants will be told that each missed medication check-in will result in a $2 deduction from the account before it is paid out. Each $50 portion (minus any penalties) of the $150 incentive will be paid out in 30-day installments by remotely crediting a previously distributed debit card. Adherence will be measured simultaneously by app photos and CleverCap(R) electronic monitoring (EM) devices filled with a 90-day supply of aspirin. Claims data will be analyzed for a 90 day period to account for any hospital admissions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Admitted to one of the University of Pennsylvania hospitals for acute myocardial infarction (ICD-10 codes I21.xx) or unstable angina (ICD 10 codes I20.xxx)
* Prescribed once-per-day aspirin at discharge
* The patient administers his or her own medications
* Own a smartphone with a sufficient data plan or home Wi-Fi to enable app use and avoid overage charges
* Able to speak and understand English
Exclusion Criteria
* Discharge to any facility other than the patient's home
* Cognitive impairment that limits ability to understand and complete questionnaires
* Inability to operate a mobile phone and the Wellth app
* Physician-estimated life expectancy less than 6 months
21 Years
ALL
No
Sponsors
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University of Pennsylvania
OTHER
Wellth Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Barbara J Riegel, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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Ho PM, Bryson CL, Rumsfeld JS. Medication adherence: its importance in cardiovascular outcomes. Circulation. 2009 Jun 16;119(23):3028-35. doi: 10.1161/CIRCULATIONAHA.108.768986.
Zhang Y, Kaplan CM, Baik SH, Chang CC, Lave JR. Medication adherence and readmission after myocardial infarction in the Medicare population. Am J Manag Care. 2014;20(11):e498-505.
Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available.
Choudhry NK, Avorn J, Glynn RJ, Antman EM, Schneeweiss S, Toscano M, Reisman L, Fernandes J, Spettell C, Lee JL, Levin R, Brennan T, Shrank WH; Post-Myocardial Infarction Free Rx Event and Economic Evaluation (MI FREEE) Trial. Full coverage for preventive medications after myocardial infarction. N Engl J Med. 2011 Dec 1;365(22):2088-97. doi: 10.1056/NEJMsa1107913. Epub 2011 Nov 14.
Jackevicius CA, Li P, Tu JV. Prevalence, predictors, and outcomes of primary nonadherence after acute myocardial infarction. Circulation. 2008 Feb 26;117(8):1028-36. doi: 10.1161/CIRCULATIONAHA.107.706820.
Ho PM, Spertus JA, Masoudi FA, Reid KJ, Peterson ED, Magid DJ, Krumholz HM, Rumsfeld JS. Impact of medication therapy discontinuation on mortality after myocardial infarction. Arch Intern Med. 2006 Sep 25;166(17):1842-7. doi: 10.1001/archinte.166.17.1842.
Choudhry NK, Avorn J, Antman EM, Schneeweiss S, Shrank WH. Should patients receive secondary prevention medications for free after a myocardial infarction? An economic analysis. Health Aff (Millwood). 2007 Jan-Feb;26(1):186-94. doi: 10.1377/hlthaff.26.1.186.
Granger BB, Bosworth HB. Medication adherence: emerging use of technology. Curr Opin Cardiol. 2011 Jul;26(4):279-87. doi: 10.1097/HCO.0b013e328347c150.
Volpp KG, Loewenstein G, Troxel AB, Doshi J, Price M, Laskin M, Kimmel SE. A test of financial incentives to improve warfarin adherence. BMC Health Serv Res. 2008 Dec 23;8:272. doi: 10.1186/1472-6963-8-272.
Kimmel SE, Troxel AB, Loewenstein G, Brensinger CM, Jaskowiak J, Doshi JA, Laskin M, Volpp K. Randomized trial of lottery-based incentives to improve warfarin adherence. Am Heart J. 2012 Aug;164(2):268-74. doi: 10.1016/j.ahj.2012.05.005.
Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16.
Riegel B, Jaarsma T, Stromberg A. A middle-range theory of self-care of chronic illness. ANS Adv Nurs Sci. 2012 Jul-Sep;35(3):194-204. doi: 10.1097/ANS.0b013e318261b1ba.
Galloway GP, Coyle JR, Guillen JE, Flower K, Mendelson JE. A simple, novel method for assessing medication adherence: capsule photographs taken with cellular telephones. J Addict Med. 2011 Sep;5(3):170-4. doi: 10.1097/ADM.0b013e3181fcb5fd.
Patel MS, Asch DA, Volpp KG. Framing Financial Incentives to Increase Physical Activity Among Overweight and Obese Adults. Ann Intern Med. 2016 Oct 18;165(8):600. doi: 10.7326/L16-0280. No abstract available.
Other Identifiers
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W000001
Identifier Type: -
Identifier Source: org_study_id
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