Clinical trial NCT03022266: A Behavioral Economics-Based Telehealth Intervention to Improve Post-MI Medication Adherence
Official title: A Behavioral Economics-Based Telehealth Intervention to Improve Post-MI Medication Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction, Acute
Myocardial Infarction
Keywords: Adherence
CleverCap® Lite BLE C035
Smartphone App
Telehealth
Digital Health
Mobile Phone App
Behavioral Economics
Aspirin
Wellth App
Lead sponsor: Wellth Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Pennsylvania
First posted: 2017-01-16
Enrollment: 130
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The proposed study is a pilot randomized clinical trial (RCT). Participants in the intervention arm will participate in a 90-day adherence promotion program based on the theory of behavioral economics and administered through the Wellth mobile phone application. Subjects will be provided a CleverCap® Lite BLE C035 smart pill bottle (electronic monitoring (EM), device) containing a 90-day supply of aspirin (90 pills) and those in the intervention arm will be offered $150 for app-based medication check-ins, which consist of uploading daily photos of pills at the time of administration through the Wellth app. Subjects will have $2 deducted from total rewards for each day that a medication check-in is missed. Subjects in the control arm will receive usual care and be monitored with the same EM device types used in the intervention arm.

Detailed description: Medication adherence is a quantifiable parameter detailing when and how consistently doses are taken. Elements of medication adherence include: 1) the proportion of prescribed drug taken or %PDT (primary outcome); 2) the proportion of days with the correct number of doses taken; 3) the proportion of doses taken on time, in relation to a prescription-defined time interval between successive doses; 4) the distribution of inter-dose intervals; 5) the number of drug holidays; and 6) the longest interval between two doses \[Vrijens et al. British journal of clinical pharmacology. 2012;73(5):691-705\]. Medication adherence will be assessed in all participants using EM technology manufactured by CleverCaps®. Electronic Monitoring (EM) is more sensitive, reliable and valid than other measurement techniques such as pill counts, self-reports, or clinical judgment \[Vrijens et al. Expert review of clinical pharmacology. 2014;7(5):633-644\]. In this study the investigators will monitor a single drug, aspirin, in MI patients prescribed aspirin on hospital discharge.

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.

Eligibility criteria: Inclusion Criteria:

* Over 21 years of age
* 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:

* Diagnosis of MI following non-cardiac admission
* 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

Primary outcomes:
measure: Medication Adherence
timeFrame: 90 Days
Secondary outcomes:
measure: 30-Day All-cause Readmissions
timeFrame: 30 Days
measure: 90-Day All-cause Readmissions
timeFrame: 90 Days
measure: Medication adherence assessed using patient smartphone photos
timeFrame: 90 Days
measure: Self-reported self-care
timeFrame: 90 Days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Barbara J Riegel, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Granger BB, Bosworth HB. Medication adherence: emerging use of technology. Curr Opin Cardiol. 2011 Jul;26(4):279-87. doi: 10.1097/HCO.0b013e328347c150.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.