Cardiac Rehabilitation of Heart Failure Patients by Telem... | NCT00877318

Studies
Cardiac Rehabilitation of Heart Failure Patients by Telemedicine

NCT00877318

Sponsor

University Hospital, Caen

Status

Terminated

Last Update Posted

Mar 18, 2016Estimated

Enrollment

64Actual

Phase

Phase 4

Conditions

Heart Failure

Interventions

SCAD information system

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

insufficient recruitment

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Apr 6, 2009

First Submission Date that Met QC Criteria

Apr 6, 2009

First Posted Date

Apr 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2016

Last Update Posted Date

Mar 18, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Program of cardiac rehabilitation introduced in complete hospitalization pursued in day hospital during 3 months
telemedicine	Experimental	Program of cardiac rehabilitation introduced in complete hospitalization pursued at home via a terminal during 3 months	Device: SCAD information system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SCAD information system	Device	Cardiac rehabilitation at home by telemedicine	telemedicine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
VO2 peak at 3 months compared with VO2 peak at the beginning of the hospitalization		3 months
BNP		3 months
% patient with a BNP < 300 pg/ml

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Annette Belin, MD	University Hospital, Caen	Principal Investigator
Rémi Sabatier, MD	University Hospital, Caen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier de la Côte Fleurie		Cricquebœuf		14113	France
William Harvey Center

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided