Behavior and Knowledges of Patients Enrolled Into SIOUX S... | NCT02900586

Studies
Behavior and Knowledges of Patients Enrolled Into SIOUX Study

NCT02900586

Sponsor

Centre Hospitalier Régional Metz-Thionville

Status

Completed

Last Update Posted

Mar 11, 2020Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Osteoporosis

Interventions

Not provided

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 2020

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

May 2016Actual

Primary Completion Date

Nov 2017Actual

Completion Date

Dec 2019Actual

First Submitted Date

Aug 26, 2016

First Submission Date that Met QC Criteria

Sep 9, 2016

First Posted Date

Sep 14, 2016Estimated

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 10, 2020

Last Update Posted Date

Mar 11, 2020Actual

Name	Class
University of Lorraine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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 this study is to contribute to the evaluation of SIOUX study by adding data about the choices of the observant patients, the mis-observant ones or the protocol deviations.

Detailed Description

The adherence to treatment for osteoporosis doesn't exceed 50% after one year. The SIOUX project about the inter-professional collaboration (attending physician with dispensary pharmacist) developed therapeutic patient education (TPE) plans and created follow-up booklets which were dealt to the patients who have to transmit it to their two medical professionals twice a year during three years one after one. The results after 18 months are encouraging about the improvement of adherence to treatment and about the lifestyle changes.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Medication management	semi-structured interview	year 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients enrolled into SIOUX study

Exclusion Criteria:

cognitive troubles which prevent the patient to participate in individual interview

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

Osteoporotic patients who have been enrolled into SIOUX study

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Didier POIVRET, MD	CHR Metz-Thionville	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital de Mercy - CHR Metz-Thionville		Metz		57085	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided