- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02461511
Impact of Therapeutic Education, Being Set up Under the Authorized Program for Diabetics Patients in Hospital (ImETh)
July 22, 2022 updated by: Hôpital Léon Bérard
Impact Des Actions d'éducation thérapeutique Mises en Place Dans le Cadre d'un Programme autorisé auprès de Patients diabétiques hospitalisés
To Assess the impact of therapeutic education on:
- the occurrence of long term diabetes complications .
- balance of his diabetes
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
evaluation of the benefits of therapeutic education by:
- glycated hemoglobin assay
- telephone monitoring
- quiz
- monitoring of adverse event related to diabete
Study Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
diabetics hospitalized patients
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Therapeutic Education + Documentation
diabetic patient hospitalized patient particpating in therapeutic education program
|
participation in a therapeutic education program on diabetes
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
glycated hemoglobin measure
Time Frame: 3 months
|
blood sample
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hopitalization
Time Frame: 3 months
|
hospitlization related to diabetes
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alkassoum Sapha, Medecin, medecin
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Anticipated)
September 1, 2016
Study Completion (Anticipated)
November 1, 2016
Study Registration Dates
First Submitted
June 1, 2015
First Submitted That Met QC Criteria
June 2, 2015
First Posted (Estimate)
June 3, 2015
Study Record Updates
Last Update Posted (Actual)
July 26, 2022
Last Update Submitted That Met QC Criteria
July 22, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Protocole#5-Version1.0
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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