Back to resultsA Trial of Telemonitoring in Adults With Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Honeywell HomMed Telemonitor
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Heart Failure (primary or secondary) diagnosis regardless of ejection fraction (EF) and New York Heart Association (NYHA) class II- IV at the time of Home Health Care (HHC) admission and HHC services initiated following a hospital stay
Exclusion Criteria:
- Inability to stand on a scale, weight over 500 pounds, unable to hear and/or see, or no working land line phone in the residence.
- Additional exclusion criteria were: patients with severe ischemic heart disease, Myocardial Infarction (MI) and/or Coronary artery bypass graft surgery(CABG) in the last 6 weeks, severe uncorrected valvular disease, home inotropic therapy, severe lung disease (oxygen dependent), active cancer, uncorrected thyroid disease, AIDS, or end stage renal disease on dialysis.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Honeywell HomMed Telemonitor
Usual care
Arm Description
TeleCareOhio Monitor (Honeywell HomeMed) system provides in-home medical monitoring for patients with chronic disease such as heart failure.
These participants receive usual care which consists of usual home-care with educational package.
Outcomes
Primary Outcome Measures
The Amount of Time Participants Are Readmitted to the Hospital or Visit the Emergency Department (ED).
Median time to combined endpoint to see if/when the participants need to be readmitted to the hospital or visit the ED
Secondary Outcome Measures
Kansas City Cardiomyopathy Questionaire
Health Status, Change in Overall Summary Score minimum: 0 maximum: 100 higher scores=better outcome
Full Information
NCT ID
NCT01393314
First Posted
July 1, 2011
Last Updated
July 18, 2022
Sponsor
Case Western Reserve University
1. Study Identification
Unique Protocol Identification Number
NCT01393314
Brief Title
A Trial of Telemonitoring in Adults With Heart Failure
Official Title
A Randomized Controlled Trial of Telemonitoring in Older Adults With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Western Reserve University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized controlled trial of telemonitoring vs usual care provided by home care agencies for patients with heart failure.
The study hypothesis is that Telemonitoring will reduce hospital re-admission rates, urgent care visits, unscheduled physician appointments, Emergency Room visits in patients with heart failure over the 60 day post hospitalization period.
Detailed Description
A 60 day stratified, randomized clinical trial of a home-based telemonitoring system (TEP) vs. usual home-care with educational package (EP). Both Groups will receive intensive patient education and primary care physicians will be prompted to adhere to heart failure management guidelines. The study will be conducted on 100 patients receiving home care nursing services post-hospital discharge.
Each participant will be randomized in equal amounts to treatment (TEP) or no treatment (EP).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Honeywell HomMed Telemonitor
Arm Type
Active Comparator
Arm Description
TeleCareOhio Monitor (Honeywell HomeMed) system provides in-home medical monitoring for patients with chronic disease such as heart failure.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
These participants receive usual care which consists of usual home-care with educational package.
Intervention Type
Device
Intervention Name(s)
Honeywell HomMed Telemonitor
Intervention Description
telemonitoring post hospitalization
Primary Outcome Measure Information:
Title
The Amount of Time Participants Are Readmitted to the Hospital or Visit the Emergency Department (ED).
Description
Median time to combined endpoint to see if/when the participants need to be readmitted to the hospital or visit the ED
Time Frame
Participants were followed for the duration of home care services up to 12 months
Secondary Outcome Measure Information:
Title
Kansas City Cardiomyopathy Questionaire
Description
Health Status, Change in Overall Summary Score minimum: 0 maximum: 100 higher scores=better outcome
Time Frame
Participants were followed for the duration of home care services up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Heart Failure (primary or secondary) diagnosis regardless of ejection fraction (EF) and New York Heart Association (NYHA) class II- IV at the time of Home Health Care (HHC) admission and HHC services initiated following a hospital stay
Exclusion Criteria:
Inability to stand on a scale, weight over 500 pounds, unable to hear and/or see, or no working land line phone in the residence.
Additional exclusion criteria were: patients with severe ischemic heart disease, Myocardial Infarction (MI) and/or Coronary artery bypass graft surgery(CABG) in the last 6 weeks, severe uncorrected valvular disease, home inotropic therapy, severe lung disease (oxygen dependent), active cancer, uncorrected thyroid disease, AIDS, or end stage renal disease on dialysis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Boxer, MD
Organizational Affiliation
Case Western Reserve Univeristy
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Trial of Telemonitoring in Adults With Heart Failure
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