A Trial of Telemonitoring in Adults With Heart Failure
A Randomized Controlled Trial of Telemonitoring in Older Adults With Heart Failure
2 other identifiers
interventional
99
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable heart-failure
Started Nov 2007
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 1, 2011
CompletedFirst Posted
Study publicly available on registry
July 13, 2011
CompletedResults Posted
Study results publicly available
August 10, 2022
CompletedAugust 10, 2022
March 1, 2022
2.3 years
July 1, 2011
March 13, 2022
July 18, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The Amount of Time Participants Are Readmitted to the Hospital or Visit the Emergency Department (ED).
Median time to combined endpoint to see if/when the participants need to be readmitted to the hospital or visit the ED
Participants were followed for the duration of home care services up to 12 months
Secondary Outcomes (1)
Kansas City Cardiomyopathy Questionaire
Participants were followed for the duration of home care services up to 12 months
Study Arms (2)
Honeywell HomMed Telemonitor
ACTIVE COMPARATORTeleCareOhio Monitor (Honeywell HomeMed) system provides in-home medical monitoring for patients with chronic disease such as heart failure.
Usual care
NO INTERVENTIONThese participants receive usual care which consists of usual home-care with educational package.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Research Compliance Officer
- Organization
- Case Western Reserve University
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca Boxer, MD
Case Western Reserve Univeristy
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2011
First Posted
July 13, 2011
Study Start
November 1, 2007
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
August 10, 2022
Results First Posted
August 10, 2022
Record last verified: 2022-03