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

NCT03034551 | Withdrawn DMC

• 1 other identifier: W000002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 30-Day Cardiac Readmissions

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

  30 Days

Secondary Outcomes (3)

• 90-Day Cardiac Readmissions

  90 Days

• Adherence to Daily Medications

  90 Days

• Adherence to Daily Self-Weighings

  90 Days

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Standard of Care (Control) Arm

NO INTERVENTION

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.

Interventions

Financial Incentive, Mobile Phone App, and Cellular Scale BEHAVIORAL

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wellth Inc.: lead
• Princeton Healthcare System: collaborator

Study Sites (1)

University Medical Center of Princeton at Plainsboro

Plainsboro, New Jersey, 08536, United States

Location

Related Publications (7)

• 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.

  PMID: 19528344 BACKGROUND

• 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.

  PMID: 16230302 BACKGROUND

• 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.

  PMID: 22825412 BACKGROUND

• 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.

  PMID: 19332417 BACKGROUND

• 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.

  PMID: 24865986 BACKGROUND

• 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.

  PMID: 25928816 BACKGROUND

• 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.

  PMID: 17846286 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Stephen R Bergmann, MD, PhD

  Princeton Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 27, 2017
• Study Start: January 30, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 9, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)