Heart FailureNCT01393314
A Trial of Telemonitoring in Adults With Heart Failure
A study testing Honeywell HomMed Telemonitor in people with Heart Failure, run by Case Western Reserve University.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Honeywell HomMed Telemonitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Mar 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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 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.
Read the 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).
- Conditions
- Heart Failure
- Being tested
- Honeywell HomMed Telemonitor
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Honeywell HomMed TelemonitorDevice
telemonitoring post hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Honeywell HomMed Telemonitor | Active comparator | TeleCareOhio Monitor (Honeywell HomeMed) system provides in-home medical monitoring for patients with chronic disease such as heart failure. Receives: Device: Honeywell HomMed Telemonitor |
| Usual care | No intervention | These participants receive usual care which consists of usual home-care with educational package. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Participants were followed for the duration of home care services up to 12 months
Secondary outcomes (1)
Kansas City Cardiomyopathy Questionaire
Health Status, Change in Overall Summary Score minimum: 0 maximum: 100 higher scores=better outcome
Measured: Participants were followed for the duration of home care services up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startNov 2007
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Boxer, MD, Principal investigator, Case Western Reserve Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393314
- Sponsor's protocol ID
- 1KL2RR024990 - 2
- Other IDs
- 1KL2RR024990
- Status last verified
- Mar 2022
- First submitted
- 1 Jul 2011
- Last updated
- 10 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Telemonitoring in Older Adults With Heart Failure
- ClinicalTrials.gov ID
- NCT01393314
- Acronym / sponsor ID
- 1KL2RR024990 - 2
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 13 Jul 2011 (estimated)
- Results
- Posted 10 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Honeywell HomMed Telemonitor | Active comparator | Device: Honeywell HomMed TelemonitorTeleCareOhio Monitor (Honeywell HomeMed) system provides in-home medical monitoring for patients with chronic disease such as heart failure. |
| Usual care | No intervention | –These participants receive usual care which consists of usual home-care with educational package. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Honeywell HomMed Telemonitortelemonitoring post hospitalization | Device | Honeywell HomMed Telemonitor |
Primary outcome
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
1 secondary outcome
Kansas City Cardiomyopathy Questionaire
Time frame: Participants were followed for the duration of home care services up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Boxer, MD principal investigator
Case Western Reserve Univeristy
Questions about this trial
What is this clinical trial studying?
A study testing Honeywell HomMed Telemonitor in people with Heart Failure, run by Case Western Reserve University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.