Automated Hovering for Congestive Heart Failure Patients

Heart Failure Clinical Trial

— EMPOWER  

Official title:

Automated Hovering for Congestive Heart Failure Management: (EMPOWER) Electronic Monitoring of Patients Offers Way to Enhance Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708654
• Other study ID #: 824816
• Secondary ID: 1R01HL128465-01
• Status: Completed
• Phase: N/A
• Start date: May 22, 2016
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 566
• Est. completion date: December 31, 2021
• Est. primary completion date: April 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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-adherence to this medication
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital readmission rate	Our primary outcome is time to readmission for any cause.The primary comparison will be the times to events compared between the intervention arm and the usual care arm; that is, the primary hypothesis is whether a series of interventions, adapted to the behavior and outcomes of each particular patient, will reduce readmission rates compared to usual care.	12 months
Secondary	Cost	To assess the cost-effectiveness of the intervention, the investigators will use analytic methods for economic evaluations in clinical trials.	12 months
Secondary	Medication adherence to diuretic as measured by electronic pill bottle	Days adherent to medication adherence to diuretic, as measured by electronic pill bottle	12 months
Secondary	Deaths	Deaths	12 months