Automated Hovering for Congestive Heart Failure Patients: A Pilot Study

University of Pennsylvania

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: Bluetooth scale; Behavioral: Support partner; Behavioral: Electronic pill bottle; Behavioral: Engagement incentives

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02689687

824067

1R01HL128465-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Engagement incentives

Behavioral: Electronic pill bottle

Behavioral: Support partner

Behavioral: Bluetooth scale