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Heart Failure Patient Self-Management Web Portal Pilot Study

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heart Self Care Tracker
Heart Care Self Tracker
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Congestive Heart Failure focused on measuring telemonitoring, internet, home monitoring system, heart failure, self management plan, web portal

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inclusion criteria

    1. Clinical diagnosis of heart failure with NYHA II-IV symptoms, or evidence of at least one heart failure hospitalization within the past 12 months.
    2. Provider permission to approach patient for enrollment
    3. Willingness to sign informed consent

Exclusion Criteria:

  • Exclusion criteria include patients who are

    1. Under the age of 19
    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

Sites / Locations

  • University of Michigan Cardiovascular Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Heart Care Self Tracker

Arm Description

Web-based Home Tele-monitoring system

Outcomes

Primary Outcome Measures

Patient adherence to heart failure-specific self care practices, as measured by the self-care practices score.

Secondary Outcome Measures

Patient satisfaction and perceptions regarding utility and acceptability of the system.

Full Information

First Posted
November 5, 2009
Last Updated
May 26, 2015
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT01009151
Brief Title
Heart Failure Patient Self-Management Web Portal Pilot Study
Official Title
University of Michigan Heart Failure Patient Self-Management Web Portal Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The study will be based on a sample of 25 heart failure patients enrolled with the UMHS Heart Failure Program who give informed consent to participate in the study. The clinical protocols and electronic software were developed by the UMHS-CVC Heart Failure Program in collaboration with the UMHS Telemedicine Resource Center. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
telemonitoring, internet, home monitoring system, heart failure, self management plan, web portal

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heart Care Self Tracker
Arm Type
Experimental
Arm Description
Web-based Home Tele-monitoring system
Intervention Type
Behavioral
Intervention Name(s)
Heart Self Care Tracker
Other Intervention Name(s)
web-based self-management system, web portal
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Heart Care Self Tracker
Intervention Description
Web-based Home Tele-monitoring System
Primary Outcome Measure Information:
Title
Patient adherence to heart failure-specific self care practices, as measured by the self-care practices score.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Patient satisfaction and perceptions regarding utility and acceptability of the system.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria 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 Exclusion Criteria: Exclusion criteria include patients who are 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd M Koelling, M.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Cardiovascular Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.umms.med.umich.edu/engage/detail_pub_study.do?show=YES&id=3759&TYPE=F
Description
Michigan Institute for Clinical and Health Research Engage Website

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Heart Failure Patient Self-Management Web Portal Pilot Study

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