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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Imperial College London.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Honeywell HomMed
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00312884
First received: April 7, 2006
Last updated: November 7, 2007
Last verified: November 2007
  Purpose

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.


Condition Intervention Phase
Heart Failure
Device: HomMed Telemonitoring System
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Home-HF: a Randomised Controlled Evaluation of Home Telemonitoring of Patients With Heart Failure Recently Discharged From Hospital.

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: May 2006
Estimated Study Completion Date: December 2007
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312884

Locations
United Kingdom
West Middlesex University Hospital
Greater London, Middlesex, United Kingdom, TW7 6AF
Ealing Hospital
London, United Kingdom, UB1 3HW
Hillingdon Hospital
Uxbridge, United Kingdom, UB8 3NN
Sponsors and Collaborators
Imperial College London
Honeywell HomMed
Investigators
Principal Investigator: Martin R Cowie, MD MSc FRCP Imperial College London & Royal Brompton and Harefield Hospital NHS Trust
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00312884     History of Changes
Other Study ID Numbers: 2006EP001B, 05/Q0411/112
Study First Received: April 7, 2006
Last Updated: November 7, 2007
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
telemonitoring
heart failure
randomised
hospitalisation
HomMed

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 20, 2014