- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01530789
Paramedical Consultation in Telemedicine
August 5, 2015 updated by: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Evaluation of Paramedical Consultation in Type 1 Diabetic Patients in Telemedicine
Feasibility monocentrique opened study estimating the use of an electronic personalized educational plan (ePEP) for the follow-up by nurses of 50 patients diabetics type 1 during 6 months having an electronic pad.
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment (Actual)
50
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
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Diabetic type 1 patients with the electronic pad
Description
Inclusion Criteria:
- patient diabetic type 1
- patient with the electronic pad in a smartphone
- adults
- children between 12 and 17 years 11 months
- patient having signed the consent
Exclusion Criteria:
- patient diabetic type 2
- patient without the electronic pad in a smartphone
- children below 12 years old
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patient using the system
Time Frame: 6 month
|
The using of the system is estimated by the frequency of dose proposition by electronic pad
|
6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
satisfaction level of the patient and quality of life
Time Frame: 6 month
|
6 month
|
|
satisfaction level of physician
Time Frame: 6 month
|
The satisfaction level of physician about the follow-up by e-PEP
|
6 month
|
satisfaction level of the telemedecin nurse
Time Frame: 6 month
|
Evaluation of the satisfaction level of the telemedecin nurse about the follow-up by e-PEP
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
May 1, 2011
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
February 8, 2012
First Submitted That Met QC Criteria
February 9, 2012
First Posted (Estimate)
February 10, 2012
Study Record Updates
Last Update Posted (Estimate)
August 6, 2015
Last Update Submitted That Met QC Criteria
August 5, 2015
Last Verified
October 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- 2011-A00311-40
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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