Automated Hovering for Congestive Heart Failure Management: (EMPOWER) Electronic Monitoring of Patients Offers Way to Enhance Rehabilitation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 566
- Locations
- 2
- Primary Endpoint
- Hospital readmission rate
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Hospital readmission rate
Time Frame: 12 months
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.
Secondary Outcomes
- Medication adherence to diuretic as measured by electronic pill bottle(12 months)
- Cost(12 months)
- Deaths(12 months)