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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (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 ]

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2. Primary:

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

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3. Primary:

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

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4. Primary:

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

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  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
First Submitted:	April 7, 2006
First Posted:	April 11, 2006
Results First Submitted:	October 27, 2015
Results First Posted:	May 30, 2016
Last Update Posted:	May 30, 2016