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Completed

NCT Number: NCT02689687

Automated Hovering for Congestive Heart Failure Patients: A Pilot Study

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Support Partner

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

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

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

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.

Primary outcomes

  1. Number of patients successfully setup on the remote monitoring devices

    Time frame: 30 days

Secondary outcomes

  1. All-cause readmission rate

    Time frame: 30 days

  2. Proportion of weight gain alerts that are opened

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 24, 2016
Registry last updated
May 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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