A Trial of Telemonitoring in Adults With Heart Failure

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Randomized Controlled Trial of Telemonitoring in Older Adults With Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Honeywell HomMed Telemonitor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Honeywell HomMed Telemonitor<br>TeleCareOhio Monitor (Honeywell HomeMed) system provides in-home medical monitoring for patients with chronic disease such as heart failure. | Device: Honeywell HomMed Telemonitor<br>* telemonitoring post hospitalization<br>|
| No Intervention: Usual care<br>These participants receive usual care which consists of usual home-care with educational package. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Participants were followed for the duration of home care services up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kansas City Cardiomyopathy Questionaire | Health Status, Change in Overall Summary Score minimum: 0 maximum: 100 higher scores=better outcome | Participants were followed for the duration of home care services up to 12 months |