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Heart FailureNCT00189852

Supporting Care and Independence at Home

A study testing Chronic heart failure monitoring system and Lifestyle monitoring system in people with Heart Failure, run by Barnsley Hospital at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Heart Failure
What is being tested?
Chronic heart failure monitoring system and Lifestyle monitoring system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteUnited Kingdom
Study dates
Nov 2005to Feb 2009
Phase
Interventional
Are there results?
None posted in the registry

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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants identified as having chronic heart failure
  • Over the age of 60
  • New York Heart Association (NYHA) functional classification 2, 3, or 4.

Who cannot join

  • Ejection fraction more than 40%
  • Under the age of 60
  • Class 1 as determined by the NYHA

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Barnsley Hospital NHS Foundation Trust

    Barnsley, Yorkshire, S75 2EP

Other trials in United Kingdom

About this study

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.
Read the 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.

Conditions
Heart Failure
Being tested
Chronic heart failure monitoring system, Lifestyle monitoring system
Keywords
Telecare, chronic, older people, heart failure
Medical subject headings
Heart Failure, Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chronic heart failure monitoring systemDevice

  • Lifestyle monitoring systemDevice

Study groups in NCT00189852
Study groupRoleWhat they receive
DocoboExperimentaltelemonitoring at home system for heart failure
Receives: Device: Chronic heart failure monitoring system; Device: Lifestyle monitoring system
ControlNo interventionNo telemonitoring system in place

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Different number of hospital admissions between groups

Secondary outcomes (2)
  1. Benefits to users

  2. Impact on carers

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2005 (estimated)
  2. Study startNov 2005
  3. Primary completionSep 2007
  4. Study completionFeb 2009

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00189852
Sponsor's protocol ID
EPSRC Grant No. GR/S29058/01
Status last verified
Feb 2016
First submitted
13 Sep 2005
Last updated
19 Feb 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Chronic heart failure monitoring system and Lifestyle monitoring system in people with Heart Failure, run by Barnsley Hospital at 1 site in United Kingdom.

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 3 inclusion and 3 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 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Different number of hospital admissions between groups. 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 19 Feb 2016.

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