Medico-economical Evaluation on Buccodental Teleexpertise in Nursing Home (e-DENT-EHPAD)

August 26, 2020 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

171

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Belmont sur Rance, France, 12370
        • EHPAD Le Sherpa
      • Castelnau-le-Lez, France, 34170
        • EHPAD Via Domitia
      • Gigean, France, 34770
        • EHPAD Korian La Colombe
      • Marseille, France, 13000
        • EHPAD Korian Perier
      • Marsillargues, France, 34590
        • EHPAD La Roselière
      • Montpellier, France, 34000
        • EHPAD Françoise Gauffier
      • Montpellier, France, 34000
        • EHPAD Korian La Pompignane
      • Montpellier, France, 34000
        • EHPAD La Carriera
      • Montpellier, France, 34000
        • EHPAD Montpellieret
      • Montpellier, France, 34000
        • EHPAD Pierre Laroque
      • Pezilla la rivière, France, 66370
        • Résidence mutualiste de Pezilla
      • Saint-Amans-des-Cots, France, 12460
        • EHPAD Saint Jean
      • St Jean Pla de Corts, France, 66490
        • EHPAD Saint Jean Pla de Corts

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

60 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: telemedecine nursing home
One buccodental teleexpertise at the completion day and a second buccodental teleexpertise at the end of study
Other: bucco-dental teleexpertise
A bucco-dental consultation remotely using telemedicine system
NO_INTERVENTION: control nursing home
Only one buccodental teleexpertise at the end of study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-Utility ratio of buccodental telemedicine in nursing home as compared to usual care
Time Frame: At month 6
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost/Efficacity ratio of buccodental telemedicine in nursing home as compared to usual care
Time Frame: At month 6

Costs include telemedicine and medical costs related to oral health care.

The clinical efficacy criteria correspond to the proportion of patients with a zero dental emergency score. The score of Emergency is measured according to WHO classification:

Score "0" correspond to "unnecessary care"

Score "1" correspond to "descaling required"

Score "2" correspond to "Low urgency: need for restoration and/or crown but not immediately (superficial damage to the tooth). Includes patients requiring fixed and/or removable prostheses".

Score "3" correspond to: "Advanced emergency: need for restorations and/or crowns quickly (within 7 to 14 days) to avoid pulp damage and/or infection"

Score "4" correspond to: "High urgency: urgent need for care due to pain and/or infection. Includes patients requiring endodontic treatment or extraction"
At month 6
Quality of life comparison: EQ5D-3L questionnaire
Time Frame: At month 6
The Quality of Life measured using the EQ5D-3L (EuroQol 3 levels of 5 dimensions) questionnaire. EQ-5D-3L questionnaire comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. Levels of perceived problems are coded as follows: Level 1 (no problems) is coded as a '1' - Level 2 (some problems) is coded as a '2' - Level 3 (extreme problems) is coded as a '3'. The best score for the 5 dimensions is coded by '11111' and the worst state is coded by '33333'. In addition a EQ visual analogue scale (EQ VAS) help people say how good or bad a health state is, on which the best state is marked 100 and the worst state is marked 0.
At month 6
Economic impact of teleexpertise on dental treatment
Time Frame: At month 6
Budgetary impact of the new coverage expressed in annual cash flows
At month 6
Evaluate satisfaction rate of use of teleexpertise of nursing home staff
Time Frame: At month 6
Satisfaction of nursing home staff measured by an ad hoc Likert scale
At month 6
Compare the emergency score
Time Frame: At month 0 and at month 6
The emergency score measured by the Oral Health Assessment Tool (OHAT) questionnaire. The OHAT comprises eight categories of screening tool to assess oral health : Lips, Tongue, Gums and tissues, Saliva, Natural teeth, Dentures, Oral cleanliness, Dental pain. After a dental examination by telemedicine, the dentist will evaluate each category as following : Score "0" correspond to "healthy", score "1" corresponds to "changes" or score "3" correspond to "unhealthy".
At month 0 and at month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Nicolas Giraudeau, DDS, MSc, CHU de Montpellier

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 (ACTUAL)

October 10, 2019

Primary Completion (ACTUAL)

February 25, 2020

Study Completion (ACTUAL)

February 25, 2020

Study Registration Dates

First Submitted

March 8, 2019

First Submitted That Met QC Criteria

March 11, 2019

First Posted (ACTUAL)

March 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 27, 2020

Last Update Submitted That Met QC Criteria

August 26, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL18_0079

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Subscribe