Overview

This trial is active, not recruiting.

Condition heart failure
Treatment hommed telemonitoring system
Phase phase 3
Sponsor Imperial College London
Collaborator Honeywell HomMed
Start date May 2006
End date December 2007
Trial size 300 participants
Trial identifier NCT00312884, 05/Q0411/112, 2006EP001B

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Number and duration of all-cause hospitalisations
time frame: Follow-up to to January 2008
Cost-effectiveness of home telemonitoring relative to usual care
time frame: Follow-up to to January 2008

Secondary Outcomes

Measure
Anxiety and depression as measured by the Hospital Anxiety and Depression (HAD) questionnaire
time frame: Follow-up to to January 2008
Health related quality of life (QoL) as measured by the Minnesota Living with Heart Failure (MLWHF) tool and the Euroqol (EQ-5D)
time frame: Follow-up to to January 2008
Readmission for Heart Failure
time frame: Follow-up to to January 2008
Drug optimisation as measured by medication prescription
time frame: Follow-up to to January 2008
Drug utilisation as measured by self-report
time frame: Follow-up to to January 2008

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Home-HF: a Randomised Controlled Evaluation of Home Telemonitoring of Patients With Heart Failure Recently Discharged From Hospital.
Principal investigator Martin R Cowie, MD MSc FRCP
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2007.
Information provided to ClinicalTrials.gov by Imperial College London.