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
  Purpose

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 Intervention
Heart Failure
Device: Honeywell HomMed Telemonitor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Telemonitoring in Older Adults With Heart Failure

Resource links provided by NLM:


Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • rehospitalization [ Time Frame: Particpants were followed for the duration of home care services up to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • health status [ Time Frame: Particpants were followed for the duration of home care services up to 12 months ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: November 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Honeywell HomMed Telemonitor Device: Honeywell HomMed Telemonitor
telemonitoring post hospitalization
No Intervention: usual care

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Rebecca Boxer, MD, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01393314     History of Changes
Other Study ID Numbers: 1KL2RR024990 - 2
Study First Received: July 1, 2011
Last Updated: July 12, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014