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

NCT ID: NCT00312884

Last Updated: 2016-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2008-09-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Care

Recieved usual hospital and community care

Group Type: ACTIVE_COMPARATOR

HomMed Telemonitoring System

Intervention Type: DEVICE

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

Intervention Arm

Recieved telemonitoring

Group Type: EXPERIMENTAL

HomMed Telemonitoring System

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Honeywell HomMed

UNKNOWN

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin R Cowie, MD MSc FRCP

Role: PRINCIPAL_INVESTIGATOR

Imperial College London & Royal Brompton and Harefield Hospital NHS Trust

Locations

West Middlesex University Hospital

Greater London, Middlesex, United Kingdom

Ealing Hospital

London, , United Kingdom

Hillingdon Hospital

Uxbridge, , United Kingdom

Countries

United Kingdom

Other Identifiers

05/Q0411/112

Identifier Type: -

Identifier Source: secondary_id

2006EP001B

Identifier Type: -

Identifier Source: org_study_id