Back to resultsCardiac Rehabilitation of Heart Failure Patients by Telemedicine (READ)
Primary Purpose
Heart Failure
Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
SCAD information system
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Patient with a dysfunction of left ventricle with ejection fraction of left ventricle < 40 % appreciated by echocardiogram at hospital discharge for cardiac rehabilitation.
Exclusion Criteria:
- Patient non authorized to follow an effort training
- Therapeutic education impossible
- Pregnant woman or breast-feeding
- No assent
- Incapacity to use the terminal
- Minor patient or under supervision
Sites / Locations
- Centre Hospitalier de la Côte Fleurie
- William Harvey Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
telemedicine
Arm Description
Program of cardiac rehabilitation introduced in complete hospitalization pursued in day hospital during 3 months
Program of cardiac rehabilitation introduced in complete hospitalization pursued at home via a terminal during 3 months
Outcomes
Primary Outcome Measures
Variation of VO2 peak at 3 months in comparison to VO2 peak at hospital discharge
Secondary Outcome Measures
VO2 peak at 3 months compared with VO2 peak at the beginning of the hospitalization
BNP
% patient with a BNP < 300 pg/ml
Medical treatment by ACE inhibitor (in % of target dose)
Ejection fraction of left ventricle
Disease knowledge questionnaire
Life quality questionnaire (Minnesota)
Beck questionnaire
Day number at hospital
Number of medical consultation
Pharmaco-economic analysis
Total mortality
Cardiovascular mortality
Full Information
NCT ID
NCT00877318
First Posted
April 6, 2009
Last Updated
March 17, 2016
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT00877318
Brief Title
Cardiac Rehabilitation of Heart Failure Patients by Telemedicine
Acronym
READ
Official Title
Cardiac Rehabilitation of Heart Failure Patients by Telemedicine: a Randomized Multicenter Study.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
insufficient recruitment
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the READ study is to compare the continuation of the cardiac rehabilitation at home with clinical follow-up, therapeutic education, and advice on the training at the stamina, via telemedicine with the classic strategy in day hospital.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Program of cardiac rehabilitation introduced in complete hospitalization pursued in day hospital during 3 months
Arm Title
telemedicine
Arm Type
Experimental
Arm Description
Program of cardiac rehabilitation introduced in complete hospitalization pursued at home via a terminal during 3 months
Intervention Type
Device
Intervention Name(s)
SCAD information system
Intervention Description
Cardiac rehabilitation at home by telemedicine
Primary Outcome Measure Information:
Title
Variation of VO2 peak at 3 months in comparison to VO2 peak at hospital discharge
Time Frame
3 months
Secondary Outcome Measure Information:
Title
VO2 peak at 3 months compared with VO2 peak at the beginning of the hospitalization
Time Frame
3 months
Title
BNP
Time Frame
3 months
Title
% patient with a BNP < 300 pg/ml
Time Frame
3 months
Title
Medical treatment by ACE inhibitor (in % of target dose)
Time Frame
3 months
Title
Ejection fraction of left ventricle
Time Frame
3 months
Title
Disease knowledge questionnaire
Time Frame
3 months
Title
Life quality questionnaire (Minnesota)
Time Frame
3 months
Title
Beck questionnaire
Time Frame
3 months
Title
Day number at hospital
Time Frame
3 months
Title
Number of medical consultation
Time Frame
3 months
Title
Pharmaco-economic analysis
Time Frame
3 months
Title
Total mortality
Time Frame
3 months
Title
Cardiovascular mortality
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with a dysfunction of left ventricle with ejection fraction of left ventricle < 40 % appreciated by echocardiogram at hospital discharge for cardiac rehabilitation.
Exclusion Criteria:
Patient non authorized to follow an effort training
Therapeutic education impossible
Pregnant woman or breast-feeding
No assent
Incapacity to use the terminal
Minor patient or under supervision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annette Belin, MD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rémi Sabatier, MD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de la Côte Fleurie
City
Cricqueboeuf
ZIP/Postal Code
14113
Country
France
Facility Name
William Harvey Center
City
Saint Martin d'Aubigny
Country
France
12. IPD Sharing Statement
Learn more about this trial
Cardiac Rehabilitation of Heart Failure Patients by Telemedicine
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