Heart Failure Clinical Trial

Automated Hovering for Congestive Heart Failure Patients

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.

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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.

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Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

566

Study ID:

NCT02708654

Recruitment Status:

Completed

Sponsor:

University of Pennsylvania

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There is 1 Location for this study

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University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

566

Study ID:

NCT02708654

Recruitment Status:

Completed

Sponsor:


University of Pennsylvania

How clear is this clinincal trial information?

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