Skip to main content
OpenTrials
Completed

NCT Number: NCT03234088

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Daily weight measured by digital scale and symptom reporting

Behavioral

All subjects will be provided the intervention.

Other names: MedApps Healthcom wireless digital scale is being utilized

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Home Based Health Monitoring for Congestive Heart Failure Pilot

Acronym: CHF

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jul 31, 2017
Registry last updated
Jul 31, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.