Automated Hovering for Congestive Heart Failure Patients: A Pilot Study

NCT ID: NCT02689687

Last Updated: 2016-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-05-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Intervention

All 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.

Group Type: EXPERIMENTAL

Support partner

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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-adherent to this medication.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin G Volpp, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

David A Asch, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Other Identifiers

1R01HL128465-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

824067

Identifier Type: -

Identifier Source: org_study_id