Impact of a Training in Therapeutic Education on the Rela... | NCT03323996

Studies
Impact of a Training in Therapeutic Education on the Relation Between Care Givers and Their Patients

NCT03323996

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Unknown status

Last Update Posted

Oct 27, 2017Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Cancer of Liver
Diabetes

Interventions

Semi-Structured interviews

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

Oct 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 26, 2017Actual

Primary Completion Date

Sep 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Oct 25, 2017

First Submission Date that Met QC Criteria

Oct 26, 2017

First Posted Date

Oct 27, 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 26, 2017

Last Update Posted Date

Oct 27, 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

This study aims to describe the impact of a training in therapeutic education on the relation between a caregiver and his/her patients.

Subjects are recruited among health professionals attending a training in therapeutic education. Then they are asked to identify up to 5 of their patients to be contacted by the researcher for an interview.

Individual semi-structured interviews are conducted with 20 duo "caregivers / patients" before the training, 1 month and 6 months after the training.

Detailed Description

Not provided

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Health Professionals		Health Professionals attending a training in therapeutic education	Other: Semi-Structured interviews
Patients		Patients of the health Professionals recruited for the study	Other: Semi-Structured interviews

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Semi-Structured interviews	Other	individual semi-structured interviews	Health Professionals Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Semi-Structured interviews	Qualitative analysis - theorical saturation	9 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed consent to participate to 3 interviews

Exclusion Criteria:

Not fluent French speaker
Patient under guardianship

Accepts Healthy Volunteers

Yes

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

Health professionnals attending a training in therapeuthic education and their patients.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cécile ZIMMERMANN, Dr	Contact	+33 3 81 66 91 61		utep.secretariat@chu-besancon.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Besançon	Recruiting	Besançon		25000	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
D008113	Liver Neoplasms
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided