Clinical trial NCT02689687: Automated Hovering for Congestive Heart Failure Patients: A Pilot Study
Official title: Automated Hovering to Improve Medication Adherence and Weight Management Among Congestive Heart Failure Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-02-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients successfully setup on the remote monitoring devices
timeFrame: 30 days
Secondary outcomes:
measure: All-cause readmission rate
timeFrame: 30 days
measure: Proportion of weight gain alerts that are opened
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: Kevin G Volpp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: David A Asch, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: