Congestive Heart Failure Pilot Study Utilizing Wireless Home Scale and Daily Symptom Monitoring (CHF)

July 27, 2017 updated by: University of Pennsylvania

Home Based Health Monitoring for Congestive Heart Failure Pilot

As the population ages and medicine advances, there has been a significant shift to the management of chronic diseases. Most chronic diseases are managed using evidence based consensus guidelines but clinician and patient compliance with these guidelines is sub-optimal. In addition, due to the nature of chronic diseases, patients need to make long-term lifestyle changes in order to effectively control their disease in order to minimize complications, disability and cost. It is these two factors, consistent implementation of evidence-based guidelines and supporting patients in a way that encourages self-management and lifestyle change, that disease management attempts to impact. There are areas of design, implementation, testing and final-result-reporting to the patient and clinician that require collaboration among information technology (IT) and software design engineers and clinicians to achieve several goals:

  1. Ensure patient safety.
  2. Protect the security and integrity of clinical data.
  3. Provide patient specific education to promote self-management.
  4. Provide actionable data to clinicians in order to improve clinical care and minimize the risk of adverse events.
  5. Provide both patient and clinician satisfaction with the system of care.

In order to achieve these goals, testing and development of home technology under a controlled clinical trial is critical.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will consist of: Specific Aim 1, Perform a pilot study to evaluate the initial performance of the wireless scale and symptom monitoring system on a select number of presumed normal volunteers (five). The purpose of this will be to determine design and process changes prior to the use of the device in subjects with chronic heart failure (HF). The investigators will have each normal volunteer (all part of the key research team) perform scenarios to test the performance of the system. Specific Aim 2 will incorporate changes into the prototype system adapting both the technology as well as the clinical workflows surrounding its use based on the information collected in Specific Aim 1. Specific Aim 3 will evaluate the revised system enrolling 40 volunteer subjects that have provided written voluntary consent with the documented primary diagnosis of HF (systolic or diastolic) to participate in the intervention over a 4-month period with the primary outcome measure being reduction in HF related ER visit or hospitalization.

The objective of this study is to pilot test and refine a new home-based telemedicine health monitoring system that provides wireless, low cost measurement of body weight as well as self-reported responses, including symptoms and medication compliance for the purpose of managing chronic heart failure (HF) within the home. This pilot will test the functionality of the research infrastructure first on 5 healthy volunteers and then on 40 patients with heart failure over 4 months, testing the receipt of accurate input from the wireless scale and then assessing the effectiveness of the scale intervention in reducing ER visits and hospitalizations.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary diagnosis of heart failure (either systolic or diastolic) NYHA class II, III and IV
  • Physical and cognitive ability to use the device
  • Cellular phone or other portable device with "text" communication capability or daily access to the internet using a computer or laptop

Exclusion Criteria:

  • Subject with life expectancy less than 6 months from any cause, or enrolled in hospice care.
  • Subject not competent or unwilling to give voluntary informed consent.
  • Subject currently participating in another home telemedicine intervention trial
  • Subjects with a left ventricular assist device or who have had a cardiac transplant
  • Dialysis upon screening or creatinine >2.5

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Home HF monitoring
Digital scale readings are transmitted wirelessly to the handheld device. Patients will remotely log on to a secure server to answer daily symptom questions. Patients will complete surveys after voluntarily completing the informed consent process and at study closeout.
Behavioral: Daily weight measured by digital scale and symptom reporting
All subjects will be provided the intervention.
Other Names:
  • MedApps Healthcom wireless digital scale is being utilized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usage of home-health monitoring devices for weight
Time Frame: Baseline through study completion, an average of four months
Monitoring daily weights and heart failure symptoms
Baseline through study completion, an average of four months

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient and Provider Questionnaires on usability and functionality of the study's online web portal (Way to Health)
Time Frame: Baseline through study completion, an average of four months
Baseline through study completion, an average of four months
Patient and Provider Questionnaires on usability and functionality of the study's wifi-enabled home health monitoring devices
Time Frame: Baseline through study completion, an average of four months
Baseline through study completion, an average of four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Lee R Goldberg, MD, MPH, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

January 21, 2011

First Submitted That Met QC Criteria

July 27, 2017

First Posted (Actual)

July 31, 2017

Study Record Updates

Last Update Posted (Actual)

July 31, 2017

Last Update Submitted That Met QC Criteria

July 27, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC2AG036592 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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