A Trial of Telemonitoring in Adults With Heart Failure

C

Case Western Reserve University

Status

Completed

Conditions

Heart Failure

Treatments

Device: Honeywell HomMed Telemonitor

Study type

Interventional

Funder types

Other

Identifiers

NCT01393314
1KL2RR024990 - 2
1KL2RR024990

Details and patient eligibility

About

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.

Full 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).

Enrollment

99 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

99 participants in 2 patient groups

Honeywell HomMed Telemonitor
Active Comparator group
Description:
TeleCareOhio Monitor (Honeywell HomeMed) system provides in-home medical monitoring for patients with chronic disease such as heart failure.
Treatment:
Device: Honeywell HomMed Telemonitor
Usual care
No Intervention group
Description:
These participants receive usual care which consists of usual home-care with educational package.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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