Cardiac Rehabilitation of Heart Failure Patients by Telemedicine (READ)

This study has been terminated.
(insufficient recruitment)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT00877318
First received: April 6, 2009
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Heart Failure
Device: SCAD information system
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cardiac Rehabilitation of Heart Failure Patients by Telemedicine: a Randomized Multicenter Study.

Resource links provided by NLM:


Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • Variation of VO2 peak at 3 months in comparison to VO2 peak at hospital discharge [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VO2 peak at 3 months compared with VO2 peak at the beginning of the hospitalization [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • BNP [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • % patient with a BNP < 300 pg/ml [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Medical treatment by ACE inhibitor (in % of target dose) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Ejection fraction of left ventricle [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Disease knowledge questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Life quality questionnaire (Minnesota) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Beck questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Day number at hospital [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of medical consultation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Pharmaco-economic analysis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Total mortality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Cardiovascular mortality [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: March 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877318

Locations
France
Centre Hospitalier de la Côte Fleurie
Cricqueboeuf, France, 14113
William Harvey Center
Saint Martin d'Aubigny, France
Sponsors and Collaborators
University Hospital, Caen
Investigators
Principal Investigator: Annette Belin, MD University Hospital, Caen
Principal Investigator: Rémi Sabatier, MD University Hospital, Caen
  More Information

No publications provided

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT00877318     History of Changes
Other Study ID Numbers: B80908-20
Study First Received: April 6, 2009
Last Updated: February 19, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014