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

May 8, 2019 updated by: Wellth Inc.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Plainsboro, New Jersey, United States, 08536
        • University Medical Center of Princeton at Plainsboro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention Arm
Subjects in the treatment arm will be offered a $150 incentive to use the Wellth app each day to log one daily self-weighing and one medication check-in. If a sudden jump in weight is detected among any subjects receiving the Financial Incentive, Mobile Phone App, and Cellular Scale, a UMCPP physician or 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).
Behavioral: Financial Incentive, Mobile Phone App, and Cellular Scale
Subjects will be provided a cellular-connected digital scale and will be offered $150 to use the app each day to log one daily self-weighing and one medication check-in. Medication check-ins consist of uploading daily photos of pills at the time of self-administration through the Wellth app. 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. If there are increasing heart failure symptoms, the physician or nurse will suggest the patient see their doctor within the next 48 hours and will notify the patient's primary care physician and cardiologist.
NO_INTERVENTION: Standard of Care (Control) Arm
Patients randomized to the standard of care arm will not receive the Wellth app or scale. They will have the usual discharge instructions as prescribed by their health care team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-Day Cardiac Readmissions
Time Frame: 30 Days
Average rates of hospital readmissions within 30 days assessed by medical record review and patient interviews
30 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
90-Day Cardiac Readmissions
Time Frame: 90 Days
Average rates of hospital readmissions within 90 days assessed by medical record review and patient interviews
90 Days
Adherence to Daily Medications
Time Frame: 90 Days
The percentage of days for which a patient submitted medication photos in the 90 days following discharge
90 Days
Adherence to Daily Self-Weighings
Time Frame: 90 Days
The percentage of days for which a patient completed a self-weighing using the provided cellular-connected scale in the 90 days following discharge
90 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wellth Inc.

Collaborators

Princeton Healthcare System

Investigators

  • Principal Investigator: Stephen R Bergmann, MD, PhD, Princeton Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 30, 2017

Primary Completion (ANTICIPATED)

December 31, 2019

Study Completion (ANTICIPATED)

December 31, 2019

Study Registration Dates

First Submitted

January 25, 2017

First Submitted That Met QC Criteria

January 26, 2017

First Posted (ESTIMATE)

January 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 9, 2019

Last Update Submitted That Met QC Criteria

May 8, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W000002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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