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Completed

NCT Number: NCT01393314

A Trial of Telemonitoring in Adults With Heart Failure

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Honeywell HomMed Telemonitor

Device

telemonitoring post hospitalization

Primary outcomes

  1. The Amount of Time Participants Are Readmitted to the Hospital or Visit the Emergency Department (ED).

    Time frame: Participants were followed for the duration of home care services up to 12 months

    Median time to combined endpoint to see if/when the participants need to be readmitted to the hospital or visit the ED

Secondary outcomes

  1. Kansas City Cardiomyopathy Questionaire

    Time frame: Participants were followed for the duration of home care services up to 12 months

    Health Status, Change in Overall Summary Score minimum: 0 maximum: 100 higher scores=better outcome

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jul 13, 2011
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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