Heart Failure Patient Self-Management Web Portal Pilot Study
University of Michigan Heart Failure Patient Self-Management Web Portal Pilot Study
1 other identifier
interventional
43
1 country
1
Brief Summary
The proposed pilot project is aimed at assessing the feasibility, acceptability and impact of a web-based home tele-monitoring system among congestive heart failure patients at the University of Michigan Health System. The intervention consists of daily reporting via the internet on health parameters, such as weight, blood pressure, heart rate and heart failure symptoms. In addition to symptom and data reporting, the system provides links to educational material on heart failure and reminders for self-care measures. It is designed as an inexpensive, user-friendly, and clinically effective system. Each patient will be provided with a unique name and password, and will be instructed on how to use the self-management website. The proposed home monitoring system study holds the potential to improve the lives of heart failure patients treated at the University of Michigan Health System by empowering them to participate actively in their care and to reduce the risk of hospitalization. As heart failure represents the most common hospital diagnosis related group (DRG)among the elderly, this study offers a significant public health benefit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 5, 2009
CompletedFirst Posted
Study publicly available on registry
November 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedMay 27, 2015
May 1, 2015
2.2 years
November 5, 2009
May 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient adherence to heart failure-specific self care practices, as measured by the self-care practices score.
12 weeks
Secondary Outcomes (1)
Patient satisfaction and perceptions regarding utility and acceptability of the system.
12 weeks
Study Arms (1)
Heart Care Self Tracker
EXPERIMENTALWeb-based Home Tele-monitoring system
Interventions
Web-based home tele-monitoring system serving congestive heart failure patients at the University of Michigan Health System. The intervention consists of daily reporting via the Internet on parameters specified in clinical protocols, including weight, blood pressure, heart rate and heart failure symptoms. These protocols contain automated trigger mechanisms when certain values are exceeded to alert the provider and the patient for the need to take appropriate remedial action. The system provides links to educational material on heart failure and reminders for self-care measures.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of heart failure with NYHA II-IV symptoms, or evidence of at least one heart failure hospitalization within the past 12 months.
- Provider permission to approach patient for enrollment
- Willingness to sign informed consent
You may not qualify if:
- Under the age of 19
- Asymptomatic heart failure
- Prisoners
- Residents of long term nursing facilities
- Receiving dialysis
- Serum creatinine ≥ 3.5 mg/dL
- Candidates for revascularization
- Candidates for valve replacement or repair
- With comorbidity (i.e. metastatic cancer) that is likely to lead to rehospitalization or death within a 12 month period
- Due to a reversible cause (i.e. hypothyroidism, anemia, etc)
- With pulmonary arterial hypertension that is not due to left ventricular dysfunction.
- Pregnant women or women of child bearing potential who are actively attempting to become pregnant or are not using an accepted form of contraception
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan Cardiovascular Center
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Todd M Koelling, M.D.
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 5, 2009
First Posted
November 6, 2009
Study Start
November 1, 2009
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
May 27, 2015
Record last verified: 2015-05