Automated Hovering for Congestive Heart Failure Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Electronic pill bottle
* Behavioral: Bluetooth scale
* Behavioral: Support Partner
* Behavioral: Engagement incentives


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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 | Behavioral: Electronic pill bottle<br>* 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<br>Behavioral: Bluetooth scale<br>* 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.<br>Behavioral: Support Partner<br>* Participants will identify a support partner who will be contacted if the participant is non-adherent to their diuretic and/or weighing-in.<br>Behavioral: Engagement incentives<br>* 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.<br>|
| No Intervention: Control<br>Participants will receive usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost | To assess the cost-effectiveness of the intervention, the investigators will use analytic methods for economic evaluations in clinical trials. | 12 months | 
| 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 | 
| Deaths | Deaths | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remote monitoring, Incentives