A Trial of Telemonitoring in Adults With Heart Failure
This study has been completed.
Sponsor:
University Hospital Case Medical Center
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
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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
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 May 23, 2013