Cardiac Rehabilitation of Heart Failure Patients by Telemedicine (READ)

March 17, 2016 updated by: University Hospital, Caen

Cardiac Rehabilitation of Heart Failure Patients by Telemedicine: a Randomized Multicenter Study.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Cricqueboeuf, France, 14113
        • Centre Hospitalier de la Côte Fleurie
      • Saint Martin d'Aubigny, France
        • William Harvey Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Program of cardiac rehabilitation introduced in complete hospitalization pursued in day hospital during 3 months
Experimental: telemedicine
Program of cardiac rehabilitation introduced in complete hospitalization pursued at home via a terminal during 3 months
Device: SCAD information system
Cardiac rehabilitation at home by telemedicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variation of VO2 peak at 3 months in comparison to VO2 peak at hospital discharge
Time Frame: 3 months
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Principal Investigator: Rémi Sabatier, MD, University Hospital, Caen
  • Principal Investigator: Annette Belin, MD, University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

April 6, 2009

First Submitted That Met QC Criteria

April 6, 2009

First Posted (Estimate)

April 7, 2009

Study Record Updates

Last Update Posted (Estimate)

March 18, 2016

Last Update Submitted That Met QC Criteria

March 17, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B80908-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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