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A Behavioral Economics-Based Telehealth Intervention to Improve Post-MI Medication Adherence

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ClinicalTrials.gov Identifier: NCT03022266
Recruitment Status : Active, not recruiting
First Posted : January 16, 2017
Last Update Posted : October 3, 2018
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Wellth Inc.

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction, Acute Myocardial Infarction Behavioral: Financial Incentive and Mobile Phone App Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: A Behavioral Economics-Based Telehealth Intervention to Improve Post-MI Medication Adherence
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : December 31, 2018

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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 Names:
  • Smartphone App
  • Wellth App
  • Adherence
  • Mobile Phone App

No Intervention: 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.



Primary Outcome Measures :
  1. Medication Adherence [ Time Frame: 90 Days ]
    Better medication adherence at 90 days as Percentage of Doses Taken (%PDT) using CleverCap(R) electronic monitoring devices


Secondary Outcome Measures :
  1. 30-Day All-cause Readmissions [ Time Frame: 30 Days ]
    Average rates of hospital readmissions within 30 days assessed by medical record review and patient interviews

  2. 90-Day All-cause Readmissions [ Time Frame: 90 Days ]
    Average rates of hospital readmissions within 90 days assessed by medical record review and patient interviews

  3. Medication adherence assessed using patient smartphone photos [ Time Frame: 90 Days ]
    % PDT will not differ between the app and electronic monitoring measurement approaches

  4. Self-reported self-care [ Time Frame: 90 Days ]
    Self-care of coronary heart disease inventory



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022266


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Wellth Inc.
University of Pennsylvania
Investigators
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Principal Investigator: Barbara J Riegel, PhD, RN University of Pennsylvania

Additional Information:
Publications:
Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Després 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. Erratum in: Circulation. 2016 Feb 23;133(8):e417. Circulation. 2015 Jun 16;131(24):e535.

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Responsible Party: Wellth Inc.
ClinicalTrials.gov Identifier: NCT03022266     History of Changes
Other Study ID Numbers: W000001
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wellth Inc.:
Adherence
CleverCap® Lite BLE C035
Smartphone App
Telehealth
Digital Health
Mobile Phone App
Behavioral Economics
Aspirin
Wellth App

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases