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Assessment of Routine Oral Screening Programs for New Prisoners (DepiDent)

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ClinicalTrials.gov Identifier: NCT03736070
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
General Health Office, France
Information provided by (Responsible Party):
University Hospital, Montpellier

Tracking Information
First Submitted Date February 1, 2018
First Posted Date November 8, 2018
Last Update Posted Date April 18, 2019
Actual Study Start Date March 1, 2018
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 7, 2018)
Description of the oral problems of people entering detention [ Time Frame: 1 day ]
Description of the oral problems of people entering detention : Any oral disease at inclusion (prevalence study)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03736070 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 7, 2018)
attending to consultations [ Time Frame: The collection of data will end at the discharge of the participant, or at 6 months after inclusion. ]
attending to consultations : The rate of attended visits is defined as the number of visits attended by the patient, divided by the number of scheduled visits, during the prison stay of the participant.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of Routine Oral Screening Programs for New Prisoners
Official Title Assessment of Routine Oral Screening Programs for New Prisoners in France
Brief Summary In 2018, 10 detention centers in France will start organisational programs to improve the quality of screening of oral diseases, relatively to French recommendations, among new prisoners in France. Our study aims 1) to assess the prevalence and nosology of oral diseases ; 2) to describe the care pathway of participants during their stay in the detention center where they were included ; 3) to assess the cost of care per patient, from a societal perspective, using a top-down method.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population New prisoners
Condition Oral Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 7, 2018)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2020
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria:

  • new prisoners
  • fluent French language

Exclusion criteria:

  • adult guardianship
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Claire M DUFLOS, MD 467336407 ext 33 c-duflos@chu-montpellier.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03736070
Other Study ID Numbers RECHMPL18_0069
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: NC
Responsible Party University Hospital, Montpellier
Study Sponsor University Hospital, Montpellier
Collaborators General Health Office, France
Investigators
Principal Investigator: Claire M DUFLOS University Hospital, Montpellier
PRS Account University Hospital, Montpellier
Verification Date March 2019