A Trial of Telemonitoring in Adults With Heart Failure

This study has been completed.
Sponsor:
Information provided by:
University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01393314
First received: July 1, 2011
Last updated: July 12, 2011
Last verified: June 2011

July 1, 2011
July 12, 2011
November 2007
March 2010   (final data collection date for primary outcome measure)
rehospitalization [ Time Frame: Particpants were followed for the duration of home care services up to 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01393314 on ClinicalTrials.gov Archive Site
health status [ Time Frame: Particpants were followed for the duration of home care services up to 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Trial of Telemonitoring in Adults With Heart Failure
A Randomized Controlled Trial of Telemonitoring in Older Adults With Heart Failure

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure
Device: Honeywell HomMed Telemonitor
telemonitoring post hospitalization
  • Active Comparator: Honeywell HomMed Telemonitor
    Intervention: Device: Honeywell HomMed Telemonitor
  • No Intervention: usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01393314
1KL2RR024990 - 2
No
Rebecca Boxer, MD, Case Western Reserve University
University Hospital Case Medical Center
Not Provided
Not Provided
University Hospital Case Medical Center
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP