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

Completed · Not applicable

Conditions studied: Congestive Heart Failure

In brief

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.

Key facts

Study ID

NCT03234088

Run by

University of Pennsylvania

People needed

13

Starts

2011-04-01

Expected to finish

2012-08-01

Last updated by the study team

2017-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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