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A Trial of Telemonitoring in Adults With Heart Failure

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ClinicalTrials.gov Identifier: NCT01393314
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : July 13, 2011
Sponsor:
Information provided by:
University Hospitals Cleveland Medical Center

Brief Summary:

This is a randomized controlled trial of telemonitoring vs usual care provided by home care agencies for atients with HF.

The study hypothesis is that Telemonitoring will reduce hospital re-admission rates, urgent care visits, unscheduled physician appointments, ER visits in patients with heart failure over the 60 day post hospitalization period.


Condition or disease Intervention/treatment Phase
Heart Failure Device: Honeywell HomMed Telemonitor Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Telemonitoring in Older Adults With Heart Failure
Study Start Date : November 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Honeywell HomMed Telemonitor Device: Honeywell HomMed Telemonitor
telemonitoring post hospitalization
No Intervention: usual care



Primary Outcome Measures :
  1. rehospitalization [ Time Frame: Particpants were followed for the duration of home care services up to 12 months ]

Secondary Outcome Measures :
  1. health status [ Time Frame: Particpants were followed for the duration of home care services up to 12 months ]


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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HF (primary or secondary) diagnosis regardless of ejection fraction (EF) and NYHA class II- IV at the time of HHC admission and HHC services initiated following a hospital stay

Exclusion Criteria:

  • inability to stand on a scale, weight over 500 lbs, 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, MI and/or 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.

Responsible Party: Rebecca Boxer, MD, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01393314     History of Changes
Other Study ID Numbers: 1KL2RR024990 - 2
1KL2RR024990 ( U.S. NIH Grant/Contract )
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: July 13, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases