Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03871569
Recruitment Status : Terminated (Difficulty recruiting and follow-up due to the epidemic context of COVID19)
First Posted : March 12, 2019
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Tooth Diseases Other: bucco-dental teleexpertise Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Medico-economical Evaluation on Buccodental Teleexpertise in Nursing Home
Actual Study Start Date : October 10, 2019
Actual Primary Completion Date : February 25, 2020
Actual Study Completion Date : February 25, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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"


  2. 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.

  3. Economic impact of teleexpertise on dental treatment [ Time Frame: At month 6 ]
    Budgetary impact of the new coverage expressed in annual cash flows

  4. 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

  5. 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".


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871569


Locations
Layout table for location information
France
EHPAD Le Sherpa
Belmont sur Rance, France, 12370
EHPAD Via Domitia
Castelnau-le-Lez, France, 34170
EHPAD Korian La Colombe
Gigean, France, 34770
EHPAD Korian Perier
Marseille, France, 13000
EHPAD La Roselière
Marsillargues, France, 34590
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
Montpellier, France, 34000
Résidence mutualiste de Pezilla
Pezilla la rivière, France, 66370
EHPAD Saint Jean
Saint-Amans-des-Cots, France, 12460
EHPAD Saint Jean Pla de Corts
St Jean Pla de Corts, France, 66490
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Layout table for investigator information
Principal Investigator: Nicolas Giraudeau, DDS, MSc CHU de Montpellier
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03871569    
Other Study ID Numbers: RECHMPL18_0079
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Telemedicine
dentistry
long-term-care-home
Additional relevant MeSH terms:
Layout table for MeSH terms
Tooth Diseases
Stomatognathic Diseases