NCT03022266

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2018

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

1.5 years

First QC Date

January 12, 2017

Last Update Submit

May 8, 2019

Conditions

Myocardial Infarction, AcuteMyocardial Infarction

Keywords

AdherenceCleverCap® Lite BLE C035Smartphone AppTelehealthDigital HealthMobile Phone AppBehavioral EconomicsAspirinWellth App

Outcome Measures

Primary Outcomes (1)

  • Medication Adherence

    Better medication adherence at 90 days as Percentage of Doses Taken (%PDT) using CleverCap(R) electronic monitoring devices

    90 Days

Secondary Outcomes (4)

  • 30-Day All-cause Readmissions

    30 Days

  • 90-Day All-cause Readmissions

    90 Days

  • Medication adherence assessed using patient smartphone photos

    90 Days

  • Self-reported self-care

    90 Days

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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.

Behavioral: Financial Incentive and Mobile Phone App

Usual Care Control Arm

NO INTERVENTION

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.

Interventions

Financial Incentive and Mobile Phone AppBEHAVIORAL

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.

Also known as: Smartphone App, Wellth App, Adherence, Mobile Phone App
Intervention Arm

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (14)

  • 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.

    PMID: 19528344BACKGROUND

  • 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.

    PMID: 25651604BACKGROUND

  • 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.

    PMID: 25520374BACKGROUND

  • 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.

    PMID: 22080794BACKGROUND

  • 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.

    PMID: 18299512BACKGROUND

  • 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.

    PMID: 17000940BACKGROUND

  • 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.

    PMID: 17211028BACKGROUND

  • Granger BB, Bosworth HB. Medication adherence: emerging use of technology. Curr Opin Cardiol. 2011 Jul;26(4):279-87. doi: 10.1097/HCO.0b013e328347c150.

    PMID: 21597368BACKGROUND

  • 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.

    PMID: 19102784BACKGROUND

  • 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.

    PMID: 22877814BACKGROUND

  • 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.

    PMID: 21080835BACKGROUND

  • 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.

    PMID: 22739426BACKGROUND

  • 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.

    PMID: 21844832BACKGROUND

  • 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.

    PMID: 27750316BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Barbara J Riegel, PhD, RN

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 16, 2017

Study Start

February 1, 2017

Primary Completion

August 16, 2018

Study Completion

November 14, 2018

Last Updated

May 9, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)