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

NCT03234088 | Completed

• 1 other identifier: RC2AG036592
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Congestive Heart Failure

Keywords

Congestive Heart Failure; Heart Failure; Home telemonitoring; Telehealth; HF Disease Management; Heart failure remote self management

Outcome Measures

Primary Outcomes (1)

• Usage of home-health monitoring devices for weight

  Monitoring daily weights and heart failure symptoms

  Baseline through study completion, an average of four months

Secondary Outcomes (2)

• Patient and Provider Questionnaires on usability and functionality of the study's online web portal (Way to Health)

  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

  Baseline through study completion, an average of four months

Study Arms (1)

Home HF monitoring

OTHER

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

Interventions

Daily weight measured by digital scale and symptom reporting BEHAVIORAL

All subjects will be provided the intervention.

Also known as: MedApps Healthcom wireless digital scale is being utilized

Home HF monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• Caveat emptor: the need for evidence, regulation, and certification of home telehealth systems for the management of chronic conditions.
• Randomized trial of a daily electronic home monitoring system in patients with advanced heart failure: the Weight Monitoring in Heart Failure (WHARF) trial.
• Validation of prognostic models among patients with advanced heart failure.
• Electronic and telemedicine techniques to manage heart failure.
• Baseline differences in the HF-ACTION trial by sex.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Lee R Goldberg, MD, MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: July 31, 2017
• Study Start: April 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2012
• Last Updated: July 31, 2017

Record last verified: 2017-07

Locations

US (1)