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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
HomMed Telemonitoring System
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring telemonitoring, heart failure, randomised, hospitalisation, HomMed

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • West Middlesex University Hospital
  • Ealing Hospital
  • Hillingdon Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Care

Intervention Arm

Arm Description

Recieved usual hospital and community care

Recieved telemonitoring

Outcomes

Primary Outcome Measures

Days Alive and Outside of Hospital
Days alive and outside of hospital (i.e. not admitted)
Patients Hospitalised (All Cause)
Number of Days Spent in Hospital
Number of Hospitalisations (All Cause)

Secondary Outcome Measures

Full Information

First Posted
April 7, 2006
Last Updated
April 26, 2016
Sponsor
Imperial College London
Collaborators
Honeywell HomMed
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1. Study Identification

Unique Protocol Identification Number
NCT00312884
Brief Title
Home-HF: Evaluation of Patients With Heart Failure Using Home Telemonitoring
Official Title
Home-HF: a Randomised Controlled Evaluation of Home Telemonitoring of Patients With Heart Failure Recently Discharged From Hospital.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
Honeywell HomMed

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
telemonitoring, heart failure, randomised, hospitalisation, HomMed

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Recieved usual hospital and community care
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Recieved telemonitoring
Intervention Type
Device
Intervention Name(s)
HomMed Telemonitoring System
Intervention Description
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
Primary Outcome Measure Information:
Title
Days Alive and Outside of Hospital
Description
Days alive and outside of hospital (i.e. not admitted)
Time Frame
From date of randomisation for 180 days
Title
Patients Hospitalised (All Cause)
Time Frame
From randomisation date to 180 days
Title
Number of Days Spent in Hospital
Time Frame
From randomisation date for 180 days
Title
Number of Hospitalisations (All Cause)
Time Frame
from randomisation for 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin R Cowie, MD MSc FRCP
Organizational Affiliation
Imperial College London & Royal Brompton and Harefield Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Middlesex University Hospital
City
Greater London
State/Province
Middlesex
ZIP/Postal Code
TW7 6AF
Country
United Kingdom
Facility Name
Ealing Hospital
City
London
ZIP/Postal Code
UB1 3HW
Country
United Kingdom
Facility Name
Hillingdon Hospital
City
Uxbridge
ZIP/Postal Code
UB8 3NN
Country
United Kingdom

12. IPD Sharing Statement

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

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