- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00189852
Supporting Care and Independence at Home
The primary objective of this project is to investigate whether, in a pilot randomised controlled trial, the use of telecare (remote monitoring) technologies reduces the frequency of hospital admissions for people with chronic heart failure (CHF) and to inform the design of a larger randomised controlled trial of telecare for CHF.
Secondary objectives are:
- To investigate whether there are benefits to users
- To understand the impact on carers in terms of carer stress
- To investigate whether there are benefits to the NHS and other statutory provisions
- To investigate which users receive the greatest benefits
- To inform whether remote monitoring of CHF patients should be provided as part of hospital discharge for a set period of time or whether it should be provided long term and be used in a preventative manner
- To investigate whether CHF episodes can be detected and predicted based on lifestyle changes
- To determine whether lifestyle monitoring equipment can be correlated with the information from the CHF monitoring system to determine the potential to detect deteriorating health.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The 2004 Department of Health publication "Improving Chronic Disease Management" highlights that: 17.5 m adults in the UK may be living with a chronic disease; Around 80% of GP admissions relate to chronic disease; Patients with a chronic disease or complications use over 60% of hospital beds. Evidence from the US suggests that people with chronic conditions consume 78% of all health spending. The NHS modernisation agency has suggested that patients with chronic diseases should, in the future, no longer end up in acute beds when they could be treated in a community setting, or supported at home.
Chronic heart failure (CHF) is a major chronic disease which has been recognised in the UK with a National Service Framework (NSF) for Coronary Heart Disease. In industrialised countries it affects 1% of the population on average and 10% at 70 years of age. It accounts for 5 per cent of all medical admissions to the hospital (120,000 hospital admissions annually) costing an estimated £360 million to the NHS with 6,000 deaths each year from CHF.
The disease has a poor prognosis as within 5 years of diagnosis there is a 50% mortality, and many debilitating, costly and unplanned hospital admissions. Indeed, as many as 50% of patients are readmitted within 3 months of initial discharge. It has been suggested that up to 50% of hospital admissions for heart failure are preventable.
Telecare proposes an earlier diagnosis and with more appropriate and timely use of drugs this can increase patient survival and their quality of life. A weight gain of just a few pounds can signal that a chronic heart failure patient is retaining fluid, for example. If caught early enough, the patient may be able to take medication or otherwise manage the problem at home, rather than having to be hospitalised which improves care and saves money. There is extensive evidence that hospitalisation rates in patients with heart failure can be substantially reduced by improved patient education, patient self monitoring of weight, and rapid response to early signs of clinical deterioration. Telehealth interventions for CHF have tended to be based on devices asking specific questions with answers being entered by users. The information provided is then often supplemented with data from weighing scales and blood pressure monitors, with this being forwarded through the telephone system to a central sever. Here medical staff review the data and respond to patients with increasing risk. Automated software is also becoming available that can highlight to practitioners when a certain patient is outside of practitioner defined parameters or is not using their equipment regularly.
Lifestyle monitoring systems, using movement detectors and magnetic proximity switches on fridge and entry doors, can generate a profile of the user's lifestyle. Deviations from the normal profile can result in an alert being generated.
Correlations between both health and lifestyle strategies have not been conducted and this trial provides this opportunity.
Within the realms of this research study the lifestyle monitoring system will not be utilising the 'alert' system. It will purely be in a data gathering mode.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Yorkshire
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Barnsley, Yorkshire, United Kingdom, S75 2EP
- Barnsley Hospital NHS Foundation Trust
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants identified as having chronic heart failure
- Over the age of 60
- New York Heart Association (NYHA) functional classification 2, 3, or 4.
Exclusion Criteria:
- Ejection fraction more than 40%
- Under the age of 60
- Class 1 as determined by the NYHA
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Docobo
telemonitoring at home system for heart failure
|
|
No Intervention: Control
No telemonitoring system in place
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Different number of hospital admissions between groups
|
Secondary Outcome Measures
Outcome Measure |
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Benefits to users
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Impact on carers
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Hawley, Barnsley Hospital NHS Foundation Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPSRC Grant No. GR/S29058/01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure
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Tufts Medical CenterMetro West Medical CenterCompletedCongestive Heart Failure | Diastolic Heart Failure | Systolic Heart FailureUnited States
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Abbott Medical DevicesCompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Reduced Ejection Fraction | Heart Failure NYHA Class IV | Heart Failure With Normal Ejection Fraction | Heart Failure; With Decompensation | Heart Failure...United States, Canada
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Manipal UniversityUnknownHeart Failure | Decompensated Heart Failure | Acute Heart Failure | Diastolic Heart Failure | Systolic Heart FailureIndia
-
VA Eastern Colorado Health Care SystemNational Institute on Aging (NIA)CompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure; With Decompensation | Heart Failure,Congestive | Heart Failure AcuteUnited States
-
University Hospital, MontpellierCompletedHeart Failure | Diastolic Heart Failure | Systolic Heart Failure Stage CFrance
-
Lancaster General HospitalLouise von Hess Medical Research InstituteEnrolling by invitationDiastolic Heart FailureUnited States
-
Wake Forest UniversityCompletedHeart Failure, Congestive | Heart Failure With Preserved Ejection Fraction
-
Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States
-
US Department of Veterans AffairsCompleted
-
Giresun UniversityIstanbul University - Cerrahpasa (IUC)RecruitingHeart Failure | Diastolic Heart Failure | Systolic Heart FailureTurkey
Clinical Trials on Chronic heart failure monitoring system
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University Health Network, TorontoCompleted
-
Massachusetts General HospitalBeth Israel Deaconess Medical CenterActive, not recruitingCongestive Heart FailureUnited States
-
Rambam Health Care CampusUnknown
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University of Colorado, DenverNot yet recruitingHeart Failure | Heart Failure NYHA Class III | Heart Failure NYHA Class IV
-
Endotronix, Inc.Active, not recruiting
-
Hôpital NOVOCompleted
-
Endotronix, Inc.TerminatedHeart Failure NYHA Class IIIUnited States
-
University of Colorado, DenverNational Heart, Lung, and Blood Institute (NHLBI)CompletedCongestive Heart Failure | Cardiac FailureUnited States
-
Johns Hopkins UniversityNational Institute of Nursing Research (NINR)CompletedHeart FailureUnited States
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Jana CareMassachusetts General HospitalCompletedHeart FailureUnited States