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

Primary Purpose

Heart Failure, Heart Failure, Congestive, Heart Failure, Systolic

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Financial Incentive, Mobile Phone App, and Cellular Scale
Sponsored by
Wellth Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring Adherence, Financial Incentives, Remote Monitoring, Self-Weighing, Behavioral Economics, Telehealth, mobile health (mHealth), Smartphone App, Wellth App

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Medical Center of Princeton at Plainsboro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm

Standard of Care (Control) Arm

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

30-Day Cardiac Readmissions
Average rates of hospital readmissions within 30 days assessed by medical record review and patient interviews

Secondary Outcome Measures

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

Full Information

First Posted
January 25, 2017
Last Updated
May 8, 2019
Sponsor
Wellth Inc.
Collaborators
Princeton Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT03034551
Brief Title
Mobile App With Patient Financial Incentives for Adherence to Heart Failure Medications & Daily Self-Weighing
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Insufficient recruitment
Study Start Date
January 30, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wellth Inc.
Collaborators
Princeton Healthcare System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Heart Failure, Congestive, Heart Failure, Systolic
Keywords
Adherence, Financial Incentives, Remote Monitoring, Self-Weighing, Behavioral Economics, Telehealth, mobile health (mHealth), Smartphone App, Wellth App

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
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).
Arm Title
Standard of Care (Control) Arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Financial Incentive, Mobile Phone App, and Cellular Scale
Intervention Description
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.
Primary Outcome Measure Information:
Title
30-Day Cardiac Readmissions
Description
Average rates of hospital readmissions within 30 days assessed by medical record review and patient interviews
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
90-Day Cardiac Readmissions
Description
Average rates of hospital readmissions within 90 days assessed by medical record review and patient interviews
Time Frame
90 Days
Title
Adherence to Daily Medications
Description
The percentage of days for which a patient submitted medication photos in the 90 days following discharge
Time Frame
90 Days
Title
Adherence to Daily Self-Weighings
Description
The percentage of days for which a patient completed a self-weighing using the provided cellular-connected scale in the 90 days following discharge
Time Frame
90 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen R Bergmann, MD, PhD
Organizational Affiliation
Princeton Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center of Princeton at Plainsboro
City
Plainsboro
State/Province
New Jersey
ZIP/Postal Code
08536
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19528344
Citation
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.
Results Reference
background
PubMed Identifier
16230302
Citation
van der Wal MH, Jaarsma T, Moser DK, Veeger NJ, van Gilst WH, van Veldhuisen DJ. Compliance in heart failure patients: the importance of knowledge and beliefs. Eur Heart J. 2006 Feb;27(4):434-40. doi: 10.1093/eurheartj/ehi603. Epub 2005 Oct 17.
Results Reference
background
PubMed Identifier
22825412
Citation
Desai AS, Stevenson LW. Rehospitalization for heart failure: predict or prevent? Circulation. 2012 Jul 24;126(4):501-6. doi: 10.1161/CIRCULATIONAHA.112.125435. No abstract available.
Results Reference
background
PubMed Identifier
19332417
Citation
Maric B, Kaan A, Ignaszewski A, Lear SA. A systematic review of telemonitoring technologies in heart failure. Eur J Heart Fail. 2009 May;11(5):506-17. doi: 10.1093/eurjhf/hfp036. Epub 2009 Mar 29.
Results Reference
background
PubMed Identifier
24865986
Citation
Maeng DD, Starr AE, Tomcavage JF, Sciandra J, Salek D, Griffith D. Can telemonitoring reduce hospitalization and cost of care? A health plan's experience in managing patients with heart failure. Popul Health Manag. 2014 Dec;17(6):340-4. doi: 10.1089/pop.2013.0107.
Results Reference
background
PubMed Identifier
25928816
Citation
Haff N, Patel MS, Lim R, Zhu J, Troxel AB, Asch DA, Volpp KG. The role of behavioral economic incentive design and demographic characteristics in financial incentive-based approaches to changing health behaviors: a meta-analysis. Am J Health Promot. 2015 May-Jun;29(5):314-23. doi: 10.4278/ajhp.140714-LIT-333.
Results Reference
background
PubMed Identifier
17846286
Citation
Chaudhry SI, Wang Y, Concato J, Gill TM, Krumholz HM. Patterns of weight change preceding hospitalization for heart failure. Circulation. 2007 Oct 2;116(14):1549-54. doi: 10.1161/CIRCULATIONAHA.107.690768. Epub 2007 Sep 10.
Results Reference
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Mobile App With Patient Financial Incentives for Adherence to Heart Failure Medications & Daily Self-Weighing

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