Validation Study of Oral Teleconsultation | NCT02904018

Studies
Validation Study of Oral Teleconsultation

NCT02904018

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Sep 16, 2016Estimated

Enrollment

700Actual

Phase

Not provided

Conditions

Dental Care

Interventions

teleconsultation

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

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Sep 7, 2016

First Submission Date that Met QC Criteria

Sep 13, 2016

First Posted Date

Sep 16, 2016Estimated

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

Sep 13, 2016

Last Update Posted Date

Sep 16, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

In this study we want to evaluate the oral care pathway after an oral teleconsultation.

Detailed Description

An oral teleconsultation was proposed to the 461 residents of the public hospital of Uzès. A specifically trained nurse recorded 4 videos (1 per quadrant) per mouth with an intra-oral camera using fluorescent light (Soprocare®) and keyed in information about the resident (general state, identification,…). These data were recorded and sent onto a central secured server, through a specific piece of software (e-DENT®). The dentists from the University Hospital of Montpellier were then able to analyse the videos remotely, make a diagnosis and organise each resident's oral care.

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

700Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
teleconsultation	Other	Patients performing oral care required as a result of their diagnosis by teleconsultation in vulnerable populations (elderly, disabled adults).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic of caries	Teleconsultation will be made using a specific camera SoproCare®6, the company Acteon	1 day

Secondary Outcomes

Measure	Description	Time Frame
Diagnostic of caries	Teleconsultation will be made using a specific camera SoproCare®6, the company Acteon	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subject is aged at least 18 years
Patients cared for in their host institution

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

People who are in long-term care home with oral telemedicine activity

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019114	Remote Consultation

Ancestor Terms

ID	Term
D012017	Referral and Consultation
D011364	Professional Practice
D009934	Organization and Administration
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided