Patient's Knowledge on Their Anticoagulating and Anti Pla... | NCT03304977

Studies
Patient's Knowledge on Their Anticoagulating and Anti Platelet Treatment St Joseph's Hospital)

NCT03304977

Sponsor

Fondation Hôpital Saint-Joseph

Status

Completed

Last Update Posted

Oct 9, 2017Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Coagulation Disorder

Interventions

questionnaire via smartphone

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

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 6, 2016Actual

Primary Completion Date

Jul 31, 2016Actual

Completion Date

Oct 30, 2016Actual

First Submitted Date

Sep 29, 2017

First Submission Date that Met QC Criteria

Oct 3, 2017

First Posted Date

Oct 9, 2017Actual

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

Oct 3, 2017

Last Update Posted Date

Oct 9, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Oral antigoagulant are used more than 60 years in thrombotic diseases. Even they are indispensable, the haemorragic risk is high.That's why it's the main reason of hospitalization for iatrogeny.The complication's reasons are mainly linked to errors of drug intake, drugs interaction and the lack of understanding the treatment.Moreover, the antiplatelet agglutening treatment is frequently added to anticoagulant treatment.This increases the haemorragic risk.Different means were used to minimize the risk , like INR follow up.

The purpose of the study is to evaluate smartphone use to follow the patients'treatment.

Detailed Description

Two questionnaire via smartphone with 15 days gap.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Name	Type	Description	Arm Group Labels	Other Names
questionnaire via smartphone	Other	questionnaire via smartphone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
smartphone use level	evaluation of the interest of patient to use their smartphone in the purpose to follow their anticoagulant treatment	15 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient under ant-thrombotic treatment
hospitalized in vascular medecine service

Exclusion Criteria:

refusing the participation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pascal PRIOLLET, MD	GHPSJ	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe Hospitalier Paris Saint Joseph		Paris	Île-de-France Region	75014	France

Condition Browse Module

MeSH Terms

ID	Term
D020141	Hemostatic Disorders

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006474	Hemorrhagic Disorders
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided