Home-HF: Evaluation of Patients With Heart Failure Using Home Telemonitorin... | Completed
Home-HF: Evaluation of Patients Wit... | Completed
Home-HF: Evaluation of Patients With Heart Failure Using Home Telemonitoring

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Medical Conditions
  • Heart Failure
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Completed
Trial source and source ID number
NCT00312884

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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.
Research Details
  • 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.
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Device : HomMed Telemonitoring System

Study Arm Groups : Usual Care, Intervention Arm

Intervention Type
See Interventions above
Primary Outcome Measures
    Days Alive and Outside of Hospital; From date of randomisation for 180 days; Patients Hospitalised (All Cause); From randomisation date to 180 days; Number of Days Spent in Hospital; From randomisation date for 180 days; Number of Hospitalisations (All Cause); from randomisation for 180 days
Secondary Outcome Measures
    Sorry, this information is not available
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
    Inclusion Criteria:

    - 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

    Exclusion Criteria:

    - Dementia/confusion which is likely to interfere with the use of the HomMed telemonitoring equipment.

    - < 18 years of age

    - Lack of home telephone line
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Hillingdon Hospital
Uxbridge
England
UB8 3NN
Ealing Hospital NHS Trust
Southall
UB1 3HW
West Middlesex University Hospital
Isleworth
Middlesex
TW7 6AF
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Home-HF: a Randomised Controlled Evaluation of Home Telemonitoring of Patients With Heart Failure Recently Discharged From Hospital.
EudraCT Number
Not available for this trial
Funder(s)
  • Honeywell HomMed
Other Study ID Numbers
2006EP001B
Sponsor(s)
Imperial College London
Key Dates

Recruitment Start Date

May 2006

Recruitment End Date

Sep 2008

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

07 Apr 2006

Date updated in source

26 Apr 2016