Home-HF: Evaluation of Patients With Heart Failure Using Home Telemonitoring

Heart Failure Clinical Trial

Official title:

Home-HF: a Randomised Controlled Evaluation of Home Telemonitoring of Patients With Heart Failure Recently Discharged From Hospital.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00312884
• Other study ID #: 2006EP001B
• Secondary ID: 05/Q0411/112
• Status: Active, not recruiting
• Phase: Phase 3
• First received: April 7, 2006
• Last updated: November 7, 2007
• Start date: May 2006
• Est. completion date: December 2007

Study information

• Verified date: November 2007
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• HomMed Telemonitoring System
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

Locations

Country	Name	City	State
United Kingdom	West Middlesex University Hospital	Greater London	Middlesex
United Kingdom	Ealing Hospital	London
United Kingdom	Hillingdon Hospital	Uxbridge

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Honeywell HomMed

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and duration of all-cause hospitalisations		Follow-up to to January 2008
Primary	Cost-effectiveness of home telemonitoring relative to usual care		Follow-up to to January 2008
Secondary	Anxiety and depression as measured by the Hospital Anxiety and Depression (HAD) questionnaire		Follow-up to to January 2008
Secondary	Health related quality of life (QoL) as measured by the Minnesota Living with Heart Failure (MLWHF) tool and the Euroqol (EQ-5D)		Follow-up to to January 2008
Secondary	Readmission for Heart Failure		Follow-up to to January 2008
Secondary	Drug optimisation as measured by medication prescription		Follow-up to to January 2008
Secondary	Drug utilisation as measured by self-report		Follow-up to to January 2008