NCT03871569

Brief Summary

Oral care in medical and social institutions is a real public health problem. The impact of poor oral health on the general state of residents but also on their overall quality of life is significant. The development of a precise regulatory framework for telemedicine in France aims to transform experiments into sustainable medical activities. Odontology often set aside in this reflection, must be reintegrated. The use of tele-expertise for the oral care of nursing home residents should make it possible to replace oral health in medico-social institutions. The investigators will assess in a cluster randomized controlled study whether the buccodental telemedicine has a viable economic model and a significant impact on the overall health of facility for dependent elderly persons residents. The medico-economic impact of the buccodental telexpertise is fundamental for the development of this innovative activity.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

October 10, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2020

Completed
Last Updated

August 27, 2020

Status Verified

August 1, 2020

Enrollment Period

5 months

First QC Date

March 8, 2019

Last Update Submit

August 26, 2020

Conditions

Tooth Diseases

Keywords

Telemedicinedentistrylong-term-care-home

Outcome Measures

Primary Outcomes (1)

  • Cost-Utility ratio of buccodental telemedicine in nursing home as compared to usual care

    Costs include telemedicine and medical costs related to oral health care. Utility correspond to the Quality Adjusted Life-Years (QALY) score measured using the EQ5D-3L questionnaire (EuroQol 3 levels of 5 dimensions).

    At month 6

Secondary Outcomes (5)

  • Cost/Efficacity ratio of buccodental telemedicine in nursing home as compared to usual care

    At month 6

  • Quality of life comparison: EQ5D-3L questionnaire

    At month 6

  • Economic impact of teleexpertise on dental treatment

    At month 6

  • Evaluate satisfaction rate of use of teleexpertise of nursing home staff

    At month 6

  • Compare the emergency score

    At month 0 and at month 6

Study Arms (2)

telemedecine nursing home

ACTIVE COMPARATOR

One buccodental teleexpertise at the completion day and a second buccodental teleexpertise at the end of study

Other: bucco-dental teleexpertise

control nursing home

NO INTERVENTION

Only one buccodental teleexpertise at the end of study

Interventions

bucco-dental teleexpertiseOTHER

A bucco-dental consultation remotely using telemedicine system

telemedecine nursing home

Eligibility Criteria

Age60 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be resident of a facility for dependent elderly persons involved in the study
  • Have given their Free, informed and signed consent
  • Beneficiary or member of a social security scheme

You may not qualify if:

  • incapacity to open the mouth
  • contrary opinion of the medical team (end of life)
  • Change of nursing home planned within 6 months
  • Subject's participation in another study
  • Subject deprived of liberty by judicial or administrative decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

EHPAD Le Sherpa

Belmont-sur-Rance, 12370, France

Location

EHPAD Via Domitia

Castelnau-le-Lez, 34170, France

Location

EHPAD Korian La Colombe

Gigean, 34770, France

Location

EHPAD Korian Perier

Marseille, 13000, France

Location

EHPAD La Roselière

Marsillargues, 34590, France

Location

EHPAD Françoise Gauffier

Montpellier, 34000, France

Location

EHPAD Korian La Pompignane

Montpellier, 34000, France

Location

EHPAD La Carriera

Montpellier, 34000, France

Location

EHPAD Montpellieret

Montpellier, 34000, France

Location

EHPAD Pierre Laroque

Montpellier, 34000, France

Location

Résidence mutualiste de Pezilla

Pezilla La Rivière, 66370, France

Location

EHPAD Saint Jean

Saint-Amans-des-Cots, 12460, France

Location

EHPAD Saint Jean Pla de Corts

St. Jean-Pla-de-Corts, 66490, France

Location

MeSH Terms

Conditions

Tooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Officials

  • Nicolas Giraudeau, DDS, MSc

    CHU de Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2019

First Posted

March 12, 2019

Study Start

October 10, 2019

Primary Completion

February 25, 2020

Study Completion

February 25, 2020

Last Updated

August 27, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(13)