NCT03304977

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 9, 2017

Completed
Last Updated

October 9, 2017

Status Verified

September 1, 2017

Enrollment Period

2 months

First QC Date

September 29, 2017

Last Update Submit

October 3, 2017

Conditions

Coagulation Disorder

Outcome Measures

Primary Outcomes (1)

  • smartphone use level

    evaluation of the interest of patient to use their smartphone in the purpose to follow their anticoagulant treatment

    15 days

Interventions

questionnaire via smartphoneOTHER

questionnaire via smartphone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient under ant-thrombotic treatment
  • hospitalized in vascular medecine service

You may not qualify if:

  • refusing the participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Pascal PRIOLLET, MD

    GHPSJ

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2017

First Posted

October 9, 2017

Study Start

June 6, 2016

Primary Completion

July 31, 2016

Study Completion

October 30, 2016

Last Updated

October 9, 2017

Record last verified: 2017-09

Locations

FR(1)