A Trial of Telemonitoring in Adults With Heart Failure

NCT ID: NCT01393314

Last Updated: 2022-08-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-03-31

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).

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Honeywell HomMed Telemonitor

TeleCareOhio Monitor (Honeywell HomeMed) system provides in-home medical monitoring for patients with chronic disease such as heart failure.

Group Type ACTIVE_COMPARATOR

Honeywell HomMed Telemonitor

Intervention Type DEVICE

telemonitoring post hospitalization

Usual care

These participants receive usual care which consists of usual home-care with educational package.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Honeywell HomMed Telemonitor

telemonitoring post hospitalization

Intervention Type DEVICE

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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Case Western Reserve University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca Boxer, MD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve Univeristy

Other Identifiers

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1KL2RR024990

Identifier Type: NIH

Identifier Source: secondary_id

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1KL2RR024990 - 2

Identifier Type: -

Identifier Source: org_study_id

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