Heart FailurePhase 3NCT00312884
Home-HF: Evaluation of Patients With Heart Failure Using Home Telemonitoring
A Phase 3 study testing HomMed Telemonitoring System in people with Heart Failure, run by Imperial College London at 3 sites in United Kingdom.
Trial summary
This project, using home monitoring for the signs and symptoms of heart failure, aims to empower patients to be actively involved in their care and provide rapid access to healthcare services and advice when needed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- HomMed Telemonitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- May 2006to Sep 2008
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NYHA class II - IV (i.e. breathlessness at rest or on mild-moderate exercise) at time of randomisation (hospital discharge)
- Proven diagnosis of heart failure, in line with the guidelines for management of chronic heart failure of the European Society of Cardiology or as determined by the cardiologist or physician caring for the patient
- Admission to hospital following a new diagnosis of heart failure or episode of acute decompensation of chronic heart failure
- Home telephone line
- Deemed fit for discharge home by the clinical team
Who cannot join
- Dementia/confusion which is likely to interfere with the use of the HomMed telemonitoring equipment.
- < 18 years of age
- Lack of home telephone line
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
West Middlesex University Hospital
Greater London, Middlesex, TW7 6AF
Ealing Hospital
London, UB1 3HW
Hillingdon Hospital
Uxbridge, UB8 3NN
About this study
Official title: Home-HF: a Randomised Controlled Evaluation of Home Telemonitoring of Patients With Heart Failure Recently Discharged From Hospital.
This project, using home monitoring for the signs and symptoms of heart failure, aims to empower patients to be actively involved in their care and provide rapid access to healthcare services and advice when needed. The telemonitoring system is easy to use and ensures the accurate transfer of information from the home to the hospital. The information is then screened and if important changes are seen, the patient will be contacted by a heart failure nurse who will offer advice and may arrange a clinic visit or suggest alterations to the medication. The project uses modern technology to provide disease management, links the patient in their home with the hospital and reinforces education and self-care behaviour. This innovative programme will be tested to see if it reduces the risk of re-admission to hospital, reduces anxiety, improves quality of life following a hospital admission for heart failure and whether this represents good value for money in terms of the health benefits it provides.
Hypothesis:
Patients using home telemonitoring of signs and symptoms of heart failure following discharge from hospital with chronic heart failure have a reduced risk of all-cause re-hospitalisation when compared with usual care.
Read the detailed description
This project, using home monitoring for the signs and symptoms of heart failure, aims to empower patients to be actively involved in their care and provide rapid access to healthcare services and advice when needed. This innovative programme will be tested to see if it reduces the risk of re-admission to hospital. In addition economic evaluation will assess whether this represents good value for money in terms of the health benefits it provides.
After fulfilling the inclusion criteria and being consented into the study, the patients will be randomised into either the control or intervention group in a 1:1 ratio.
Intervention Group:
Prior to hospital discharge the patient and carer/family will be shown how to use the HomMed Telemonitoring equipment. Within two working days of discharge the equipment will be installed in their home by the study nurse who will remind them of its use. They will be provided with a written management plan and advice regarding self-monitoring.They will be asked to monitor signs and symptoms of their disease daily using the HomMed telemonitoring system connected to their home phone line.
The data will be reviewed every working day by a study nurse and examined for variance from the agreed parameters. If clinically significant changes are noted a standard protocol will be used to guide the management.
Control group:
Within two working days of discharge the study nurse will visit patients in the control group and provide them with a written management plan and advice regarding self-monitoring. They will receive usual care for that centre which will consist of a recommendation to visit their GP on hospital discharge and a subsequent review in the outpatient clinic. Informal support offered through the hospital heart failure nurse will continue and this contact will be recorded.
Within both groups the Hospital Anxiety and Depression (HAD) questionnaire, the Minnesota Living with Heart Failure(MLWHF) tool and the Euroqol (EQ-5D) questionnaire will be completed at randomisation, and again at 3 and 6 months following hospital discharge. They will be asked to return completed questionnaires in a pre-paid envelope.
Data on patients' use of healthcare services will be collected from both groups using a combination of retrospective questionnaires and prospective health diaries, which will be returned at 3 and 6 months after randomisation.
Drug optimisation will be assessed through review of medication prescription, and drug utilisation through patient self-report.These data will also be collected at 3 and 6 months.
Patients within both groups will be involved in the study for a period of 6 months.
- Conditions
- Heart Failure
- Being tested
- HomMed Telemonitoring System
- Keywords
- telemonitoring, heart failure, randomised, hospitalisation, HomMed
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HomMed Telemonitoring SystemDevice
The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Recieved usual hospital and community care Receives: Device: HomMed Telemonitoring System |
| Intervention Arm | Experimental | Recieved telemonitoring Receives: Device: HomMed Telemonitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days Alive and Outside of Hospital
Days alive and outside of hospital (i.e. not admitted)
Measured: From date of randomisation for 180 days
Patients Hospitalised (All Cause)
Measured: From randomisation date to 180 days
Number of Days Spent in Hospital
Measured: From randomisation date for 180 days
Number of Hospitalisations (All Cause)
Measured: from randomisation for 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2006 (estimated)
- Study startMay 2006
- Primary completionSep 2008
- Study completionSep 2008
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.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Honeywell HomMed
- Responsible party
- Sponsor
- Investigators
- Martin R Cowie, MD MSc FRCP, Principal investigator, Imperial College London & Royal Brompton and Harefield Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312884
- Sponsor's protocol ID
- 2006EP001B
- Other IDs
- 05/Q0411/112
- Status last verified
- Nov 2007
- First submitted
- 7 Apr 2006
- Last updated
- 30 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-HF: a Randomised Controlled Evaluation of Home Telemonitoring of Patients With Heart Failure Recently Discharged From Hospital.
- ClinicalTrials.gov ID
- NCT00312884
- Acronym / sponsor ID
- 2006EP001B
- Conditions
- Heart Failure
- Keywords
- telemonitoring, heart failure, randomised, hospitalisation, HomMed
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Honeywell HomMed
- Study start
- May 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 11 Apr 2006 (estimated)
- Results
- Posted 30 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project, using home monitoring for the signs and symptoms of heart failure, aims to empower patients to be actively involved in their care and provide rapid access to healthcare services and advice when needed. The telemonitoring system is easy to use and ensures the accurate transfer of information from the home to the hospital. The information is then screened and if important changes are seen, the patient will be contacted by a heart failure nurse who will offer advice and may arrange a clinic visit or suggest alterations to the medication. The project uses modern technology to provide disease management, links the patient in their home with the hospital and reinforces education and self-care behaviour. This innovative programme will be tested to see if it reduces the risk of re-admission to hospital, reduces anxiety, improves quality of life following a hospital admission for heart failure and whether this represents good value for money in terms of the health benefits it provides.
Hypothesis:
Patients using home telemonitoring of signs and symptoms of heart failure following discharge from hospital with chronic heart failure have a reduced risk of all-cause re-hospitalisation when compared with usual care.
Detailed description
This project, using home monitoring for the signs and symptoms of heart failure, aims to empower patients to be actively involved in their care and provide rapid access to healthcare services and advice when needed. This innovative programme will be tested to see if it reduces the risk of re-admission to hospital. In addition economic evaluation will assess whether this represents good value for money in terms of the health benefits it provides.
After fulfilling the inclusion criteria and being consented into the study, the patients will be randomised into either the control or intervention group in a 1:1 ratio.
Intervention Group:
Prior to hospital discharge the patient and carer/family will be shown how to use the HomMed Telemonitoring equipment. Within two working days of discharge the equipment will be installed in their home by the study nurse who will remind them of its use. They will be provided with a written management plan and advice regarding self-monitoring.They will be asked to monitor signs and symptoms of their disease daily using the HomMed telemonitoring system connected to their home phone line.
The data will be reviewed every working day by a study nurse and examined for variance from the agreed parameters. If clinically significant changes are noted a standard protocol will be used to guide the management.
Control group:
Within two working days of discharge the study nurse will visit patients in the control group and provide them with a written management plan and advice regarding self-monitoring. They will receive usual care for that centre which will consist of a recommendation to visit their GP on hospital discharge and a subsequent review in the outpatient clinic. Informal support offered through the hospital heart failure nurse will continue and this contact will be recorded.
Within both groups the Hospital Anxiety and Depression (HAD) questionnaire, the Minnesota Living with Heart Failure(MLWHF) tool and the Euroqol (EQ-5D) questionnaire will be completed at randomisation, and again at 3 and 6 months following hospital discharge. They will be asked to return completed questionnaires in a pre-paid envelope.
Data on patients' use of healthcare services will be collected from both groups using a combination of retrospective questionnaires and prospective health diaries, which will be returned at 3 and 6 months after randomisation.
Drug optimisation will be assessed through review of medication prescription, and drug utilisation through patient self-report.These data will also be collected at 3 and 6 months.
Patients within both groups will be involved in the study for a period of 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Device: HomMed Telemonitoring SystemRecieved usual hospital and community care |
| Intervention Arm | Experimental | Device: HomMed Telemonitoring SystemRecieved telemonitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- NYHA class II - IV (i.e. breathlessness at rest or on mild-moderate exercise) at time of randomisation (hospital discharge)
- Proven diagnosis of heart failure, in line with the guidelines for management of chronic heart failure of the European Society of Cardiology or as determined by the cardiologist or physician caring for the patient
- Admission to hospital following a new diagnosis of heart failure or episode of acute decompensation of chronic heart failure
- Home telephone line
- Deemed fit for discharge home by the clinical team
Key exclusion criteria (3 listed)
- Dementia/confusion which is likely to interfere with the use of the HomMed telemonitoring equipment.
- < 18 years of age
- Lack of home telephone line
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 |
|---|---|---|
| HomMed Telemonitoring SystemThe HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home | Device | Intervention Arm, Usual Care |
Primary outcome
Days Alive and Outside of Hospital
Time frame: From date of randomisation for 180 days
Days alive and outside of hospital (i.e. not admitted)
Patients Hospitalised (All Cause)
Time frame: From randomisation date to 180 days
Number of Days Spent in Hospital
Time frame: From randomisation date for 180 days
Number of Hospitalisations (All Cause)
Time frame: from randomisation for 180 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Heart Failure
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Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
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Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Martin R Cowie, MD MSc FRCP principal investigator
Imperial College London & Royal Brompton and Harefield Hospital NHS Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HomMed Telemonitoring System in people with Heart Failure, run by Imperial College London at 3 sites 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 5 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 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2016). 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?
Days Alive and Outside of Hospital (time frame: From date of randomisation for 180 days). The study lists 4 primary outcomes in all. 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 30 May 2016.