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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 22, 2014