Heart Failure Patient Self-Management Web Portal Pilot Study
NCT ID: NCT01009151
Last Updated: 2015-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
43 participants
INTERVENTIONAL
2009-11-30
2012-01-31
Brief Summary
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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.
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Detailed Description
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The UMHS Heart Failure Disease Management Program contains a registry of more than 3000 patients with heart failure problems. Currently, a multidisciplinary nursing team maintains routine contacts with these patients through telephone calls and paper records. The program has been acknowledged for its adherence to quality of care measures, and was the first to be awarded accreditation by JCAHO for ambulatory heart failure care. Despite its relative success, patients continue to be at high risk for re-hospitalization due to worsened heart function. The proposed tele-monitoring system is expected to reduce the need for re-hospitalization and to improve health outcomes by virtue of automated daily reporting and greater patient involvement in self-management. Because of its high promise, this area of research has been receiving increased attention, but so far without definitive results. Previous research has provided evidence of reduced emergency room visits and hospitalizations, improved patient compliance with care and overall cost containment among high-risk patient populations. But the studies relied on relatively expensive systems involving specialized hardware and proprietary software. The cost of these interventions presents a limitation to the broad adoption and use of the technology. The proposed project is an attempt to ascertain the optimal method from a clinical and cost standpoint for in-home telemonitoring for this large patient population that is likely to grow with the aging of the population.
The primary end-points of this pilot are: (1) patient willingness to use the system, perceptions regarding its efficacy and effectiveness and problems encountered in its use; (2) patient adherence to heart failure-specific self care practices; (3) patient health literacy and quality of life; and (4) provider perceptions of the efficacy and effectiveness of the system and problems encountered in its use.
The findings should be helpful in refining the clinical protocols and data management algorithms and establishing a solid foundation for large-scale randomized clinical trials for obtaining the necessary evidence for wide-scale adoption of these systems in the United States and elsewhere.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Heart Care Self Tracker
Web-based Home Tele-monitoring system
Heart Self Care Tracker
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.
Heart Care Self Tracker
Web-based Home Tele-monitoring System
Interventions
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Heart Self Care Tracker
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.
Heart Care Self Tracker
Web-based Home Tele-monitoring System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Provider permission to approach patient for enrollment
3. Willingness to sign informed consent
Exclusion Criteria
2. Asymptomatic heart failure
3. Prisoners
4. Residents of long term nursing facilities
5. Receiving dialysis
6. Serum creatinine ≥ 3.5 mg/dL
7. Candidates for revascularization
8. Candidates for valve replacement or repair
9. With comorbidity (i.e. metastatic cancer) that is likely to lead to rehospitalization or death within a 12 month period
10. Due to a reversible cause (i.e. hypothyroidism, anemia, etc)
11. With pulmonary arterial hypertension that is not due to left ventricular dysfunction.
12. Pregnant women or women of child bearing potential who are actively attempting to become pregnant or are not using an accepted form of contraception
19 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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Todd M. Koelling, M.D.
Associate Professor
Principal Investigators
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Todd M Koelling, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan Cardiovascular Center
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00024778
Identifier Type: -
Identifier Source: org_study_id
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