Impact of Therapeutic Education, Being Set up Under the A... | NCT02461511

Studies
Impact of Therapeutic Education, Being Set up Under the Authorized Program for Diabetics Patients in Hospital

NCT02461511

Sponsor

Hôpital Léon Bérard

Status

Withdrawn

Last Update Posted

Jul 26, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Diabetes Complications

Interventions

Therapeutic Education

Countries

Not provided

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

Jul 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No funding

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Sep 2016Estimated

Completion Date

Nov 2016Estimated

First Submitted Date

Jun 1, 2015

First Submission Date that Met QC Criteria

Jun 2, 2015

First Posted Date

Jun 3, 2015Estimated

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

Jul 22, 2022

Last Update Posted Date

Jul 26, 2022Actual

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

To Assess the impact of therapeutic education on:

the occurrence of long term diabetes complications .
balance of his diabetes

Detailed Description

evaluation of the benefits of therapeutic education by:

glycated hemoglobin assay
telephone monitoring
quiz
monitoring of adverse event related to diabete

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Therapeutic Education + Documentation	diabetic patient hospitalized patient particpating in therapeutic education program	Other: Therapeutic Education
No Therapeutic Education No Documents	diabetic patient hospitalized patient without therapeutic education program no documentation submitted
Documentation, No Therapeutic Education	diabetic patient hospitalized patient without therapeutic education program documentation submitted

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Therapeutic Education	Other	participation in a therapeutic education program on diabetes	Therapeutic Education + Documentation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
glycated hemoglobin measure	blood sample	3 months

Secondary Outcomes

Measure	Description	Time Frame
hopitalization	hospitlization related to diabetes	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Patients

diabetic
hospitalized in Léon Berard
with telephone line
written consent given
belong to a social security system

Exclusion Criteria:

no diabetics
patient having alredy completing a therapeutic education program
minor patient (<18 years)
pregnant woman
without telephone line
no belong to a social security system
patient alredy inclued on clinical study.
patient tutelage or under curatorship

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

diabetics hospitalized patients

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Alkassoum Sapha, Medecin	medecin	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D048909	Diabetes Complications

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided