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
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction, Acute Myocardial Infarction||Behavioral: Financial Incentive and Mobile Phone App||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
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.
- Medication Adherence [ Time Frame: 90 Days ]Better medication adherence at 90 days as Percentage of Doses Taken (%PDT) using CleverCap(R) electronic monitoring devices
- 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
- 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
- Medication adherence assessed using patient smartphone photos [ Time Frame: 90 Days ]% PDT will not differ between the app and electronic monitoring measurement approaches
- Self-reported self-care [ Time Frame: 90 Days ]Self-care of coronary heart disease inventory
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
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Barbara J Riegel, PhD, RN||University of Pennsylvania|