Home-HF: Evaluation of Patients With Heart Failure Using Home Telemonitoring | Not Recruiting
Home-HF: Evaluation of Patients With Heart Failure Using Home Telemonitoring
Health Conditions
  • Heart Failure
Not Recruiting
Recruitment Status
NCT00312884
Primary Trial ID Number
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.
Primary Outcome Measures
  • Number and duration of all-cause hospitalisations; Follow-up to to January 2008; Cost-effectiveness of home telemonitoring relative to usual care; Follow-up to to January 2008
Secondary Outcome Measures
  • Anxiety and depression as measured by the Hospital Anxiety and Depression (HAD) questionnaire; 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); Follow-up to to January 2008; Readmission for Heart Failure; Follow-up to to January 2008; Drug optimisation as measured by medication prescription; Follow-up to to January 2008; Drug utilisation as measured by self-report; Follow-up to to January 2008
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
300
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
  • 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
Interventions
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; []
Design Details
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Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
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Acronym
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Scientific Title
Home-HF: a Randomised Controlled Evaluation of Home Telemonitoring of Patients With Heart Failure Recently Discharged From Hospital.
Secondary Trial Identifying Number
05/Q0411/112
Website
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Study Funded By
Imperial College London
Funder Type
Sorry, this information is not available
Study Sponsored By
Imperial College London
Study Also Sponsored By
Honeywell HomMed
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

07 Apr 2006

Last Updated

07 Nov 2007

Date Record Refreshed on UKCTG

31 Jul 2015