Automated Hovering for Congestive Heart Failure Patients (EMPOWER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02708654|
Recruitment Status : Recruiting
First Posted : March 15, 2016
Last Update Posted : December 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Behavioral: Electronic pill bottle Behavioral: Bluetooth scale Behavioral: Support Partner Behavioral: Engagement incentives||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||566 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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.
- Total cost of hospitalizations [ Time Frame: 12 month ]Total cost of hospitalizations for 12 months after enrollment
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
|Contact: Laurie Norton, MA||215.573.8799||Laurie.Norton@uphs.upenn.edu|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Laurie Norton, MA 215-573-4010 email@example.com|
|Contact: Noora Marcus, MA 215-746-4429 Noora.Marcus@uphs.upenn.edu|