NCT00312884

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P25-P50 for phase_3 heart-failure

Timeline
Completed

Started May 2006

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2006

Completed
20 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
7.7 years until next milestone

Results Posted

Study results publicly available

May 30, 2016

Completed
Last Updated

May 30, 2016

Status Verified

November 1, 2007

Enrollment Period

2.3 years

First QC Date

April 7, 2006

Results QC Date

October 27, 2015

Last Update Submit

April 26, 2016

Conditions

Heart Failure

Keywords

telemonitoringheart failurerandomisedhospitalisationHomMed

Outcome Measures

Primary Outcomes (4)

  • Days Alive and Outside of Hospital

    Days alive and outside of hospital (i.e. not admitted)

    From date of randomisation for 180 days

  • Patients Hospitalised (All Cause)

    From randomisation date to 180 days

  • Number of Days Spent in Hospital

    From randomisation date for 180 days

  • Number of Hospitalisations (All Cause)

    from randomisation for 180 days

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Recieved usual hospital and community care

Device: HomMed Telemonitoring System

Intervention Arm

EXPERIMENTAL

Recieved telemonitoring

Device: HomMed Telemonitoring System

Interventions

HomMed Telemonitoring SystemDEVICE

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

Intervention ArmUsual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Dementia/confusion which is likely to interfere with the use of the HomMed telemonitoring equipment.
  • \< 18 years of age
  • Lack of home telephone line

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

West Middlesex University Hospital

Greater London, Middlesex, TW7 6AF, United Kingdom

Location

Ealing Hospital

London, UB1 3HW, United Kingdom

Location

Hillingdon Hospital

Uxbridge, UB8 3NN, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Professor Cowie
Organization
Imperial College london
m.cowie@imperial.ac.uk
0207 349 7716

Study Officials

  • Martin R Cowie, MD MSc FRCP

    Imperial College London & Royal Brompton and Harefield Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2006

First Posted

April 11, 2006

Study Start

May 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

May 30, 2016

Results First Posted

May 30, 2016

Record last verified: 2007-11

Locations

GB(3)