Home-HF: Evaluation of Patients With Heart Failure Using Home Telemonitoring | Not Recruiting
Home-HF: Evaluation of Patients With Heart Failure Using Home Telemonitoring

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Heart Failure
Unfortunately contact details are not available for this trial.
Primary Contact Details
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.
Research Details
  • 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.
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Device : HomMed Telemonitoring System
Intervention Type
See Interventions above
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
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
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
This is in the inclusion criteria above
Trial Location(s)
Novartis Investigative Site
Uxbridge
UB8 3NN
Ealing Hospital
London
UB1 3HW
West Middlesex University Hospital
Greater London
Middlesex
TW7 6AF
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
Home-HF: a Randomised Controlled Evaluation of Home Telemonitoring of Patients With Heart Failure Recently Discharged From Hospital.
EudraCT Number
Not available for this trial
Funder(s)
  • Honeywell HomMed
Other Study ID Numbers
2006EP001B
Sponsor(s)
Imperial College London
Key Dates

Recruitment Start Date

May 2006

Recruitment End Date
Date Not Available
Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

07 Apr 2006

Last Updated

07 Nov 2007