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

This study has been completed.
Sponsor:
Collaborator:
Honeywell HomMed
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT00312884
First received: April 7, 2006
Last updated: April 26, 2016
Last verified: November 2007
Results First Received: October 27, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Heart Failure
Intervention: Device: HomMed Telemonitoring System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intervention Arm Recieved home telemonitoring daily HomMed Telemonitoring System: The HomeMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home
Usual Care Received usual hospital care with no Telemonitoring

Participant Flow:   Overall Study
    Intervention Arm   Usual Care
STARTED   91   91 
COMPLETED   74   79 
NOT COMPLETED   17   12 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Usual Care Recieved usual follow-up care
Intervention Arm Received daily home monitoring
Total Total of all reporting groups

Baseline Measures
   Usual Care   Intervention Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 91   91   182 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   30   30   60 
>=65 years   61   61   122 
Age 
[Units: Years]
Mean (Standard Deviation)
 72  (10.4)   70  (12.8)   71  (11) 
Gender 
[Units: Participants]
     
Female   32   29   61 
Male   59   62   121 
Region of Enrollment 
[Units: Participants]
     
United Kingdom   91   91   182 


  Outcome Measures
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1.  Primary:   Days Alive and Outside of Hospital   [ Time Frame: From date of randomisation for 180 days ]

2.  Primary:   Patients Hospitalised (All Cause)   [ Time Frame: From randomisation date to 180 days ]

3.  Primary:   Number of Days Spent in Hospital   [ Time Frame: From randomisation date for 180 days ]

4.  Primary:   Number of Hospitalisations (All Cause)   [ Time Frame: from randomisation for 180 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Professor Cowie
Organization: Imperial College london
phone: 0207 349 7716
e-mail: m.cowie@imperial.ac.uk



Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00312884     History of Changes
Other Study ID Numbers: 2006EP001B
05/Q0411/112
Study First Received: April 7, 2006
Results First Received: October 27, 2015
Last Updated: April 26, 2016
Health Authority: United Kingdom: Research Ethics Committee