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

Primary Purpose

Tooth Diseases

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
bucco-dental teleexpertise
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tooth Diseases focused on measuring Telemedicine, dentistry, long-term-care-home

Eligibility Criteria

60 Years - 120 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • EHPAD Le Sherpa
  • EHPAD Via Domitia
  • EHPAD Korian La Colombe
  • EHPAD Korian Perier
  • EHPAD La Roselière
  • EHPAD Françoise Gauffier
  • EHPAD Korian La Pompignane
  • EHPAD La Carriera
  • EHPAD Montpellieret
  • EHPAD Pierre Laroque
  • Résidence mutualiste de Pezilla
  • EHPAD Saint Jean
  • EHPAD Saint Jean Pla de Corts

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

telemedecine nursing home

control nursing home

Arm Description

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

Only one buccodental teleexpertise at the end of study

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Cost/Efficacity ratio of buccodental telemedicine in nursing home as compared to usual care
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"
Quality of life comparison: EQ5D-3L questionnaire
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.
Economic impact of teleexpertise on dental treatment
Budgetary impact of the new coverage expressed in annual cash flows
Evaluate satisfaction rate of use of teleexpertise of nursing home staff
Satisfaction of nursing home staff measured by an ad hoc Likert scale
Compare the emergency score
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".

Full Information

First Posted
March 8, 2019
Last Updated
August 26, 2020
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT03871569
Brief Title
Medico-economical Evaluation on Buccodental Teleexpertise in Nursing Home
Acronym
e-DENT-EHPAD
Official Title
Medico-economical Evaluation on Buccodental Teleexpertise in Nursing Home
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Difficulty recruiting and follow-up due to the epidemic context of COVID19
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
February 25, 2020 (Actual)
Study Completion Date
February 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Diseases
Keywords
Telemedicine, dentistry, long-term-care-home

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
telemedecine nursing home
Arm Type
Active Comparator
Arm Description
One buccodental teleexpertise at the completion day and a second buccodental teleexpertise at the end of study
Arm Title
control nursing home
Arm Type
No Intervention
Arm Description
Only one buccodental teleexpertise at the end of study
Intervention Type
Other
Intervention Name(s)
bucco-dental teleexpertise
Intervention Description
A bucco-dental consultation remotely using telemedicine system
Primary Outcome Measure Information:
Title
Cost-Utility ratio of buccodental telemedicine in nursing home as compared to usual care
Description
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).
Time Frame
At month 6
Secondary Outcome Measure Information:
Title
Cost/Efficacity ratio of buccodental telemedicine in nursing home as compared to usual care
Description
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"
Time Frame
At month 6
Title
Quality of life comparison: EQ5D-3L questionnaire
Description
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.
Time Frame
At month 6
Title
Economic impact of teleexpertise on dental treatment
Description
Budgetary impact of the new coverage expressed in annual cash flows
Time Frame
At month 6
Title
Evaluate satisfaction rate of use of teleexpertise of nursing home staff
Description
Satisfaction of nursing home staff measured by an ad hoc Likert scale
Time Frame
At month 6
Title
Compare the emergency score
Description
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".
Time Frame
At month 0 and at month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Giraudeau, DDS, MSc
Organizational Affiliation
CHU de Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
EHPAD Le Sherpa
City
Belmont sur Rance
ZIP/Postal Code
12370
Country
France
Facility Name
EHPAD Via Domitia
City
Castelnau-le-Lez
ZIP/Postal Code
34170
Country
France
Facility Name
EHPAD Korian La Colombe
City
Gigean
ZIP/Postal Code
34770
Country
France
Facility Name
EHPAD Korian Perier
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
EHPAD La Roselière
City
Marsillargues
ZIP/Postal Code
34590
Country
France
Facility Name
EHPAD Françoise Gauffier
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
EHPAD Korian La Pompignane
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
EHPAD La Carriera
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
EHPAD Montpellieret
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
EHPAD Pierre Laroque
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Résidence mutualiste de Pezilla
City
Pezilla la rivière
ZIP/Postal Code
66370
Country
France
Facility Name
EHPAD Saint Jean
City
Saint-Amans-des-Cots
ZIP/Postal Code
12460
Country
France
Facility Name
EHPAD Saint Jean Pla de Corts
City
St Jean Pla de Corts
ZIP/Postal Code
66490
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Medico-economical Evaluation on Buccodental Teleexpertise in Nursing Home

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