Automated Hovering for Congestive Heart Failure Patients: A Pilot Study

Automated Hovering to Improve Medication Adherence and Weight Management Among Congestive Heart Failure Patients: A Pilot Study

This study offers remote monitoring devices for weight and medication adherence, combined with behavioral economic approaches, to patients with congestive heart failure (CHF). This pilot study aims to evaluate the feasibility of enrollment processes and intervention roll-out to inform a randomized controlled trial, to estimate the readmission rate of participants, and to assess if and how managing clinicians respond to weight gain alerts entered into a participant's electronic medical record.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: Bluetooth scale; Behavioral: Engagement incentives; Behavioral: Support partner; Behavioral: Electronic pill bottle

Detailed Description

The specific aims of this study are: (1) To leverage access to the University of Pennsylvania Health System (UPHS) CHF clinic, PennChart (electronic medical record system) resources for identifying eligible patients, and the Way to Health (WTH) platform to launch a pilot study that will inform a randomized controlled trial; (2) to evaluate the feasibility of the enrollment processes and intervention roll-out to inform a randomized controlled trial; (3) to estimate the readmission rate of participants; and, (4) to assess if and how managing physicians respond to weight gain alerts entered into participant charts in PennChart. In this pilot study, no randomization will occur and all participants will receive the intervention.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Discharged to home within the past 30 days from a UPHS hospital with a principal diagnosis of CHF
• Aged 18 to 80 years old
• Will receive follow-up in a UPHS outpatient clinic by a cardiologist or primary care physician

Exclusion Criteria:

• Less than 18 years old or older than 80 years old
• Will not or cannot provide informed consent
• Have a markedly shortened life expectancy (listed for heart transplant, have ventricular assist device, are inotrope dependent, have metastatic cancer, or have dementia)
• Have end-stage renal disease
• Have a glomerular filtration rate <25 ml/min
• On dialysis
• Heart failure is managed with a CardioMEMS monitor
• Receiving another remote monitoring/telemedicine intervention
• Receiving follow-up care outside of UPHS

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; All participants will be (1) given an electronic pill bottle for their diuretic and a Bluetooth scale; (2) asked to provide the coordinator with name and contact information of a family member or friend to serve as a support partner; (3) will be assigned a 2-digit number to be used as part of the lottery-based engagement incentives in which eligibility to win will be conditional on medication adherence and registering a weight measurement; and, (4) will determine their preferences for Way to Health platform communication methods during the study.

Behavioral: Bluetooth scale; Participant adherence to stepping on their scale will be monitored on a daily basis and participants will be contacted if they are non-adherent to weighing-in. Participant weight gain will also be monitored, and if weight gain exceeds a specific threshold, the managing physician will be notified through the electronic medical record system. Managing providers will also be sent a weekly report of weight measurements.; Behavioral: Engagement incentives; Participants will be entered into a daily lottery, for which their participation is contingent on adhering to their diuretic and to weighing-in on the previous day.; Behavioral: Support partner; Participants will identify a support partner who will be contacted if the participant is non-adherent to their diuretic and/or weighing-in.; Behavioral: Electronic pill bottle; Participant adherence to their diuretic will be monitored on a daily basis and participants will be contacted if they are non-adherent to this medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients successfully setup on the remote monitoring devices	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
All-cause readmission rate	30 days
Proportion of weight gain alerts that are opened	30 days

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Kevin G Volpp, MD, PhD, University of Pennsylvania; Principal Investigator: David A Asch, MD, MBA, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: January 28, 2016
• First Submitted That Met QC Criteria: February 18, 2016
• First Posted (Estimate): February 24, 2016

Study Record Updates

• Last Update Posted (Estimate): May 11, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 824067; 1R01HL128465-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO