Supporting Care and Independence at Home
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Chronic heart failure monitoring system
Lifestyle monitoring system
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure focused on measuring Telecare, chronic, older people, heart failure
Eligibility Criteria
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
Sites / Locations
- Barnsley Hospital NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Docobo
Control
Arm Description
telemonitoring at home system for heart failure
No telemonitoring system in place
Outcomes
Primary Outcome Measures
Different number of hospital admissions between groups
Secondary Outcome Measures
Benefits to users
Impact on carers
Full Information
NCT ID
NCT00189852
First Posted
September 13, 2005
Last Updated
February 18, 2016
Sponsor
Barnsley Hospital
Collaborators
Engineering and Physical Sciences Research Council, UK, Imperial College London, University College, London, University of Dundee, Anchor Trust, Thomas Pocklington Trust, Tunstall
1. Study Identification
Unique Protocol Identification Number
NCT00189852
Brief Title
Supporting Care and Independence at Home
Official Title
Supporting Care and Independence at Home
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Barnsley Hospital
Collaborators
Engineering and Physical Sciences Research Council, UK, Imperial College London, University College, London, University of Dundee, Anchor Trust, Thomas Pocklington Trust, Tunstall
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Telecare, chronic, older people, heart failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Docobo
Arm Type
Experimental
Arm Description
telemonitoring at home system for heart failure
Arm Title
Control
Arm Type
No Intervention
Arm Description
No telemonitoring system in place
Intervention Type
Device
Intervention Name(s)
Chronic heart failure monitoring system
Intervention Type
Device
Intervention Name(s)
Lifestyle monitoring system
Primary Outcome Measure Information:
Title
Different number of hospital admissions between groups
Secondary Outcome Measure Information:
Title
Benefits to users
Title
Impact on carers
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Hawley
Organizational Affiliation
Barnsley Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnsley Hospital NHS Foundation Trust
City
Barnsley
State/Province
Yorkshire
ZIP/Postal Code
S75 2EP
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Supporting Care and Independence at Home
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