Cardiac Rehabilitation of Heart Failure Patients by Telemedicine

Phase 4

Terminated

• Conditions: Heart Failure
• Interventions: Device: SCAD information system

• Registration Number: NCT00877318
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-06
• Study First Submitted QC: 2009-04-06
• Study First Posted: 2009-04-07
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-17
• Last Update Posted: 2016-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
telemedicine	SCAD information system	Program of cardiac rehabilitation introduced in complete hospitalization pursued at home via a terminal during 3 months

Primary Outcome Measures

Name	Time	Method
Variation of VO2 peak at 3 months in comparison to VO2 peak at hospital discharge	3 months

Secondary Outcome Measures

Name	Time	Method
Medical treatment by ACE inhibitor (in % of target dose)	3 months
Life quality questionnaire (Minnesota)	3 months
Number of medical consultation	3 months
Total mortality	3 months
VO2 peak at 3 months compared with VO2 peak at the beginning of the hospitalization	3 months
% patient with a BNP < 300 pg/ml	3 months
Beck questionnaire	3 months
BNP	3 months
Ejection fraction of left ventricle	3 months
Day number at hospital	3 months
Cardiovascular mortality	3 months
Disease knowledge questionnaire	3 months
Pharmaco-economic analysis	3 months

Trial Locations

Locations (2)

Centre Hospitalier de la Côte Fleurie; 🇫🇷 Cricqueboeuf, France

William Harvey Center; 🇫🇷 Saint Martin d'Aubigny, France