Automated Hovering for Congestive Heart Failure Patients: A Pilot Study

Heart Failure Clinical Trial

Official title:

Automated Hovering to Improve Medication Adherence and Weight Management Among Congestive Heart Failure Patients: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689687
• Other study ID #: 824067
• Secondary ID: 1R01HL128465-01
• Status: Completed
• Phase: N/A
• First received: January 28, 2016
• Last updated: May 10, 2016
• Start date: February 2016
• Est. completion date: May 2016

Study information

• Verified date: February 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study offers remote monitoring devices for weight and medication adherence, combined with behavioral economic approaches, to patients with congestive heart failure (CHF). This pilot study aims to evaluate the feasibility of enrollment processes and intervention roll-out to inform a randomized controlled trial, to estimate the readmission rate of participants, and to assess if and how managing clinicians respond to weight gain alerts entered into a participant's electronic medical record.

Description:

The specific aims of this study are: (1) To leverage access to the University of Pennsylvania Health System (UPHS) CHF clinic, PennChart (electronic medical record system) resources for identifying eligible patients, and the Way to Health (WTH) platform to launch a pilot study that will inform a randomized controlled trial; (2) to evaluate the feasibility of the enrollment processes and intervention roll-out to inform a randomized controlled trial; (3) to estimate the readmission rate of participants; and, (4) to assess if and how managing physicians respond to weight gain alerts entered into participant charts in PennChart. In this pilot study, no randomization will occur and all participants will receive the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Discharged to home within the past 30 days from a UPHS hospital with a principal diagnosis of CHF

• Aged 18 to 80 years old

• Will receive follow-up in a UPHS outpatient clinic by a cardiologist or primary care physician

Exclusion Criteria:

• Less than 18 years old or older than 80 years old

• Will not or cannot provide informed consent

• Have a markedly shortened life expectancy (listed for heart transplant, have ventricular assist device, are inotrope dependent, have metastatic cancer, or have dementia)

• Have end-stage renal disease

• Have a glomerular filtration rate <25 ml/min

• On dialysis

• Heart failure is managed with a CardioMEMS monitor

• Receiving another remote monitoring/telemedicine intervention

• Receiving follow-up care outside of UPHS

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.
• 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.
• Electronic pill bottle
Participant adherence to their diuretic will be monitored on a daily basis and participants will be contacted if they are non-adherent to this medication.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients successfully setup on the remote monitoring devices		30 days	No
Secondary	All-cause readmission rate		30 days	No
Secondary	Proportion of weight gain alerts that are opened		30 days	No