Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00189852
Status:
COMPLETED
Last Update Posted:
2016-02-19
First Post:
2005-09-13
Brief Title:
Supporting Care and Independence at Home
Sponsor:
Barnsley Hospital
Organization:
Barnsley Hospital
Study Overview
Official Title:
Supporting Care and Independence at Home
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
1 To investigate whether there are benefits to users
2 To understand the impact on carers in terms of carer stress
3 To investigate whether there are benefits to the NHS and other statutory provisions
4 To investigate which users receive the greatest benefits
5 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
6 To investigate whether CHF episodes can be detected and predicted based on lifestyle changes
7 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
Secondary objectives are
1 To investigate whether there are benefits to users
2 To understand the impact on carers in terms of carer stress
3 To investigate whether there are benefits to the NHS and other statutory provisions
4 To investigate which users receive the greatest benefits
5 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
6 To investigate whether CHF episodes can be detected and predicted based on lifestyle changes
7 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 175 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 120000 hospital admissions annually costing an estimated 360 million to the NHS with 6000 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 users 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
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 120000 hospital admissions annually costing an estimated 360 million to the NHS with 6000 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 users 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None