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Trial record 146 of 323 for:    coronary heart disease OR heart disease OR coronary artery disease OR atherosclerosis | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Automated Hovering for Congestive Heart Failure Patients (EMPOWER)

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ClinicalTrials.gov Identifier: NCT02708654
Recruitment Status : Recruiting
First Posted : March 15, 2016
Last Update Posted : December 26, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: Electronic pill bottle Behavioral: Bluetooth scale Behavioral: Support Partner Behavioral: Engagement incentives Not Applicable

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 the total cost of hospitalizations. We 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 weight measurements.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 566 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Automated Hovering for Congestive Heart Failure Management: (EMPOWER) Electronic Monitoring of Patients Offers Way to Enhance Rehabilitation
Actual Study Start Date : May 22, 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Intervention
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
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

Behavioral: 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.

Behavioral: 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.

Behavioral: 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.

No Intervention: Control
Participants will receive usual care.



Primary Outcome Measures :
  1. Hospital readmission rate [ Time Frame: 12 months ]
    To leverage access to the University of Pennsylvania Health System Congestive Heart Failure clinic, the electronic medical record (EMR) resources for identifying eligible patients, and the Way to Health platform to launch and enroll a practical clinical trial powered to detect differences in hospital readmission rates using remote monitoring devices for automated hovering for congestive heart failure management.


Secondary Outcome Measures :
  1. Total cost of hospitalizations [ Time Frame: 12 month ]
    Total cost of hospitalizations for 12 months after enrollment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708654


Contacts
Contact: Laurie Norton, MA 215.573.8799 Laurie.Norton@uphs.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Laurie Norton, MA    215-573-4010    lanorton@mail.med.upenn.edu   
Contact: Noora Marcus, MA    215-746-4429    Noora.Marcus@uphs.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02708654     History of Changes
Other Study ID Numbers: 1R01HL128465-01 ( U.S. NIH Grant/Contract )
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Only aggregate data will be shared, not on individual level

Keywords provided by University of Pennsylvania:
Remote monitoring
Incentives

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Diuretics
Natriuretic Agents
Physiological Effects of Drugs