Automated Hovering for Congestive Heart Failure Patients: A Pilot Study

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Behavioral: Support partner; Behavioral: Engagement incentives; Behavioral: Electronic pill bottle; Behavioral: Bluetooth scale

• Registration Number: NCT02689687
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-01-28
• Status Verified: 2016-02
• Study Start: 2016-02
• Study First Submitted QC: 2016-02-18
• Study First Posted: 2016-02-24
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Engagement incentives	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.
Intervention	Electronic pill bottle	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.
Intervention	Support partner	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.
Intervention	Bluetooth scale	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.

Primary Outcome Measures

Name	Time	Method
Number of patients successfully setup on the remote monitoring devices	30 days

Secondary Outcome Measures

Name	Time	Method
Proportion of weight gain alerts that are opened	30 days
All-cause readmission rate	30 days