Automated Hovering for Congestive Heart Failure Patients (EMPOWER)

University of Pennsylvania

Status: Completed

Conditions: Heart Failure

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02708654

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

824816

Details and patient eligibility

About

Using a 2-arm, randomized controlled trial (RCT) among CHF patients at the University of Pennsylvania Health System (UPHS), to test the effectiveness of applying automated hovering to improve outcomes among CHF patients at high risk of readmission.

Full description

Using a 2-arm, randomized, controlled trial (RCT) among congestive heart failure (CHF) patients at the University of Pennsylvania Health System (UPHS), to test the effectiveness of applying automated hovering to improve outcomes among CHF patients at high risk of readmission. This will leverage the electronic medical record (EMR), the Penn Data Store (an electronic repository that can be used to identify study cohorts), and the NIH-funded Way to Health platform, which provides linkages between home-based remote monitoring devices and a server that can provide automated feedback to patients. The primary outcome will be hospital readmission rate during the 12 months of study enrollment. Secondary outcomes will include cost, medication adherence and death. The investigators will enroll CHF patients discharged from UPHS and randomize them to either: usual care with no additional intervention; or 1) the provision of wireless pill bottles and scales with daily lottery incentives to encourage daily adherence 2) asked to provide the name and contact information of a family member or friend to serve as their support partner 3) have their weights monitored for clinically significant threshold, with verified weight gains alerts sent to the managing physician through the EMR. Managing providers will also be sent a weekly report of all weight measurements from the electronic scale.

Enrollment: 566 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with a recent University of Pennsylvania Health System hospital (UPHS) discharge of congestive heart failure (CHF) aged 18-80 who will receive follow-up in a UPHS outpatient clinic.

Exclusion criteria

• Patients will be excluded if they will not or cannot give consent or have a markedly shortened life expectancy (listed for heart transplant,have a ventricular assist device, are inotrope dependent, metastatic cancer, or dementia)
• end-stage renal disease (since they may not produce urine and be responsive to diuretics).
• on dialysis
• Heart failure managed with a CardioMEMS monitor
• Receiving another remote monitoring/telemedicine intervention
• Receiving follow up care outside of UPHS

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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566 participants in 2 patient groups

Intervention

Experimental group

Description:

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.(5) Research coordinators to remotely monitor weight gain thresholds and add alert into the participant's electronic health record for verified weight gain

Treatment:

Behavioral: Support Partner

Behavioral: Electronic pill bottle

Behavioral: Engagement incentives

Behavioral: Bluetooth scale

Control

No Intervention group

Description:

Participants will receive usual care.