Therapeutic Education by Telemedicine in Chronic Heart Fa... | NCT00878202

Studies
Therapeutic Education by Telemedicine in Chronic Heart Failure

NCT00878202

Sponsor

University Hospital, Caen

Status

Terminated

Last Update Posted

Feb 20, 2013Estimated

Enrollment

100Actual

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

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

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Apr 6, 2009

First Submission Date that Met QC Criteria

Apr 7, 2009

First Posted Date

Apr 8, 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

Feb 19, 2013

Last Update Posted Date

Feb 20, 2013Estimated

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 SEDIC study is to test a home based heart failure patient clinical follow-up and therapeutic education using telemedicine. This educational follow-up is based on an interactive information system (SCAD) including a touch screen personal computer for heart failure patient at home. An interactive algorithm has been developed to allow a self management teaching to the patient.Furthermore, a specialized nurse provide a clinical data follow-up.

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Optimal medical treatment of Heart failure and therapeutic education
Telemedicine	Experimental	Optimal medical treatment of heart failure disease and therapeutic education	Device: SCAD information system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SCAD information system	Device	Clinical follow-up and continuation of therapeutic education by telemedicine during 3 months	Telemedicine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of hospitalization days for heart failure		12 months

Secondary Outcomes

Measure	Description	Time Frame
Cardiovascular mortality		12 months
Total mortality		12 months
Rate of hospitalization for heart failure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients > 65 years old hospitalized for acute heart failure
Left ventricle systolic Dysfunction with ejection fraction < 45 %, documented in the previous 6 months
And at least one of the following criteria:

BNP before discharge from hospital > 350 pg/ml / EF < 35 % / Hospitalization for acute heart failure informed in the previous 6 months

Exclusion Criteria:

NYHA 4 at hospital discharge
Planned cardiac surgery or coronary revascularization
Hospitalization for ST-elevation acute coronary syndrome
Depressive syndrome with score > 20 at geriatric depression scale
Therapeutic education impossible
Technical problems with the device
Limited autonomy for device use
Patient not living in Basse-Normandie
Ongoing participation in another clinical trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

95 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alençon-Mamers Hospital		Alençon		61000	France
Caen University Hospital

Type	Date	Date Unknown
Release	Jul 20, 2017
Reset	Dec 14, 2017

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 20, 2017			Dec 14, 2017

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