A Randomized Controlled Trial of Telemonitoring in Older Adults With Heart Failure
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Case Western Reserve University
- Enrollment
- 99
- Primary Endpoint
- The Amount of Time Participants Are Readmitted to the Hospital or Visit the Emergency Department (ED).
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
- Kansas City Cardiomyopathy Questionaire(Participants were followed for the duration of home care services up to 12 months)