Mobile App With Patient Financial Incentives for Adherence to Heart Failure Medications & Daily Self-Weighing



Status:Suspended
Conditions:Obesity Weight Loss, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:18 - Any
Updated:9/2/2018
Start Date:January 30, 2017
End Date:December 31, 2019

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Randomized Controlled Trial of a Mobile App With Patient Financial Incentives for Tracking and Improving Adherence to Medications & Daily Self-Weighing to Reduce Heart Failure Readmissions

The goal of this study is to test the efficacy of a financial incentives-based telehealth
intervention to reduce 30- and 90-day heart failure (HF) readmissions by tracking and
increasing adherence to patient self-care - specifically by incentivizing adherence to
prescribed cardiac medication regimen and daily self-weighing. Patients randomized to the
treatment arm will be given a cellular-connected scale to use at home, as well as a mobile
app on their smartphone that tracks their adherence to daily self-weighing through the scale
and cardiac medications via patient photo submission. The health care team will intervene if
a sudden increase in weight is detected (2 lbs/day or 5 lbs/week). Financial incentives of
$150 are offered for full adherence over 90 days. Each day where the patient does not step on
the scale and complete a medication check-in will result in a deduction of $2 per day from
the incentive amount to be paid out. The control group will receive the usual discharge
instructions as prescribed by their health care team.

Nonadherence to cardiovascular medications and daily weight monitoring are critical issues in
readmissions to the hospital for heart failure. Only 60% of patients adhere to prescribed
cardiovascular medications on at least 80% of days, and only 40% monitor their weight daily,
despite owning scales. Nationally, nonadherence contributes to excessive HF readmission rates
of 50% within 6 months, and 24% within 30 days of discharge. To raise awareness and
accountability, the Centers for Medicare & Medicaid Services (CMS) began reporting these
rates in 2009, and the Affordable Care Act and value-based contracts with payers have
established financial penalties to spur provider-based solutions.

Telehealth interventions are an ideal, low-cost, scalable method to reduce readmissions by
remotely enhancing patient support. Telehealth interventions for HF that target medication
compliance and self-weighing have demonstrated reductions in readmission rates by 80% or
more, but these are not yet widely adopted in clinical practice due to a lack of randomized,
controlled studies. We are thus proposing a randomized, controlled study of a proprietary
telehealth platform at University Medical Center of Princeton at Plainsboro (UMCPP) to enable
remote support for HF patients through a mobile app combined with financial incentives to
motivate adherence to medication and self-weighing. Patients admitted to UMCPP with the
primary admitting or discharge diagnosis of heart failure with reduced ejection fraction
(EF<40%) (ICD-10 codes I50.2_) will be invited to participate in the study.

Each patient in the intervention arm will be offered $150 in incentives along with the Wellth
app loaded on to his or her smartphone. When users first log in to the app, which will occur
with the guidance of a healthcare provider trained in its use, they will be shown a large
dollar amount that they have earned by enrolling in the program - in this study $150 will be
offered for 90 days of perfect adherence to medications and daily self-weighing using
connected digital scales provided by Wellth. Instructions will also be given stating that
missed weight and medication check-ins will result in a $2 deduction per day from the account
to be paid out at each monthly pay period.

If a 2 lb. or greater daily increase in weight, or a 5 lb. weekly increase in weight, is
detected in any patient, a UMCPP physician or nurse will be alerted via automatic email and
text. A physician or a nurse will then call the patient to assess the patient's symptoms
(i.e. increasing shortness of breath or decreases in exertional tolerance, medication and
dietary adherence). Once a weight gain alert has been triggered, the team will continue to
receive additional data about the patient for the next 7 days to see if weight continues to
increase which would trigger an additional phone call and patient physician notification.

After a call is made to the patient, if, in the clinical judgment of the physician or nurse
that there are increasing heart failure symptoms, the physician or nurse will suggest to the
patient that they make an appointment and see their doctor within the next 48 hours.

Benefits of this study to the intervention arm include better health, reduced risk of
readmission, and concomitant reduction in healthcare burden, as well as a small but tangible
financial gain. Benefits for society, assuming widely applicable success, include reduction
in population-wide readmission rates due to greater health, and reduction in healthcare
spending.

Inclusion Criteria:

- Admitted to or discharged from University Medical Center of Princeton at Plainsboro
(UMPCC) with the primary diagnosis of heart failure with reduced ejection fraction
(ICD-10 code I50.2x)

- Standard of care medications for heart failure with reduced ejection fraction

- Own a smart phone with a sufficient data plan or home Wi-Fi. Up to 30 phones can be
provided if needed.

- Able to speak and understand either English or Spanish and able to learn the Wellth
app.

Exclusion Criteria:

- Diagnosis of HF following non-cardiac admission

- Discharge to a care facility (anywhere that is not home)

- Inability to step on a scale and steady oneself to obtain an accurate weight

- Cognitive impairment or documented psychiatric illness that limits ability to
understand and respond to health-related questions

- Inability to operate a mobile phone
We found this trial at
1
site
1 Plainsboro Road
Plainsboro, New Jersey 08536
Principal Investigator: Stephen R Bergmann, MD, PhD
Phone: 609-853-7220
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mi
from
Plainsboro, NJ
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