Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00312884
Status:
COMPLETED
Last Update Posted:
2016-05-30
First Post:
2006-04-07
Brief Title:
Home-HF Evaluation of Patients With Heart Failure Using Home Telemonitoring
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Home-HF a Randomised Controlled Evaluation of Home Telemonitoring of Patients With Heart Failure Recently Discharged From Hospital
Status:
COMPLETED
Status Verified Date:
2007-11
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:
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
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 11 ratio
Intervention Group
Prior to hospital discharge the patient and carerfamily 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-monitoringThey 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 FailureMLWHF 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-reportThese 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
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 11 ratio
Intervention Group
Prior to hospital discharge the patient and carerfamily 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-monitoringThey 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 FailureMLWHF 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-reportThese 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 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05Q0411112 | None | None | None |