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Validation of a French-language Version of Quality of Life Questionnaires in Patients With Peripheral Facial Palsy (PFQDV)

Primary Purpose

Peripheral Facial Paralysis, Quality of Life

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Facial disability Index" (FDi)
"Facial Clinimetric Evaluation" (FaCE)
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Peripheral Facial Paralysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with peripheral facial palsy
  • Age over 18 years old.
  • Subject wishing and able to give informed consent and to respect the requirements of the protocol

Exclusion Criteria:

  • Patient not being French.
  • Patient who can not read French.
  • Facial graduation.
  • Facial dysfunction other than PFP such as facial trauma.
  • Major medical or psychiatric illness that, in the opinion of the investigator, would pose a risk to the subject or could compromise compliance with the study protocol.
  • Participation in other studies in the 30 days prior to inclusion in this study.
  • Legal incapacity or limited legal capacity.

Sites / Locations

  • Assistance Publique Des Hopitaux de MarseilleRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

peripheral facial palsy patients

Arm Description

peripheral facial palsy patients will performed questionnaires of quality of life ("Facial disability Index" (FDi) and "Facial Clinimetric Evaluation" (FaCE)

Outcomes

Primary Outcome Measures

"Facial disability Index" (FDi)
questionnaire to assess the oral, ocular and the influence of facial impairment on emotions and daily activity

Secondary Outcome Measures

Facial Clinimetric Evaluation" (FaCE)
questionnaire to asses facial deficit and disability relating to 6 areas: facial movement, facial comfort, oral function, ocular comfort, tear control and social function
House-Brackmann score
The House-Brackmann score is a score to grade the degree of nerve damage in a facial nerve palsy. The measurement is determined by measuring the upwards (superior) movement of the mid-portion of the top of the eyebrow, and the outwards (lateral) movement of the angle of the mouth. Each reference point scores 1 point for each 0.25 cm movement, up to a maximum of 1 cm. The scores are then added together, to give a number out of 8
Sunnybrook index
clinical evaluation calculating a score depending of Resting Symmetry, Symmetry of Voluntary Movement and Synkinesis
SF-36 score
The Short Form (36) Health Survey is a 36-item. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Pricing depends on the number of scores that the researcher needs to calculate. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health

Full Information

First Posted
June 26, 2018
Last Updated
July 11, 2018
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT03581253
Brief Title
Validation of a French-language Version of Quality of Life Questionnaires in Patients With Peripheral Facial Palsy
Acronym
PFQDV
Official Title
Validation of a French-language Version of Specific Quality of Life Questionnaires in Patients With Peripheral Facial Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
December 15, 2018 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

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
Facial palsy is a serious and disabling disease whose drudgery and sensation are probably underestimated. Psychological, social and economic issues have major impacts although vital prognosis is not engaged in this pathology. Facial palsy remains a personal drama for patient. Consequences may take the form of: aesthetic deformation, modification of body image, with socio-professional consequences. Beside unsightly facial aspects, weakness of facial muscles can cause troubles in eating, drinking, talking, communicating personal emotions and communication. Facial palsy impacts patients' quality of life (QOL) and affects mental health. This wide multidimensional concept usually includes self-measures of physical and mental health. QOL is evaluated with general and specific scales. General scales allow to compare QOL of different diseases, when specific scales focus on one disease and consider all aspects related to this disease and therefore are more appropriate and sensitive in dimensions related to patient disease and health. "Facial disability Index" (FDi) and "Facial Clinimetric Evaluation" (FaCE) are the most used validated questionnaires to assess QOL of patients suffering from peripheral facial palsy (PFP). There is no existing validated questionnaire or scale in French version despite many French studies on PFP available. Using these questionnaires in French language requires translation and strict approval of the new language version. The aim of the study is to translate and validate French versions of specific scales of QOL in peripheral facial palsy patients: FDI and FaCE. Secondary objective is to evaluate QOL of patients depending on PFP etiology. Translation process will be done respecting internationally recognized rules. A pilot study will be performed on 5 physicians and 5 patients in order to validate the questionnaires translations. French versions obtained will be used for their validation on 80 patients suffering from PFP. Cronbach's alpha will be estimated to check internal consistency of FDI and FaCE scales. Test re-test reliability will be calculated with inter-class correlation, reiterating questionnaires one week later. Scores of FDI and FaCE scales will be compared to other clinical evaluation scales, estimating correlation coefficient. Social function of FDI and FaCE scales will be compared with general scale SF-36 scores, estimating a correlation coefficient.
Detailed Description
Facial palsy is a serious and disabling disease whose drudgery and sensation are probably underestimated. Psychological, social and economic issues have major impacts although vital prognosis is not engaged in this pathology. Facial palsy remains a personal drama for patient. Consequences may take the form of: aesthetic deformation, modification of body image, with socio-professional consequences. Beside unsightly facial aspects, weakness of facial muscles can cause troubles in eating, drinking, talking, and communicating personal emotions. Physical as well as psychological repercussions limit daily verbal and non-verbal communication. Facial palsy impacts patients' quality of life (QOL) and affects mental health. Consequently, QOL impacts and directs the patient's care and the healthcare professionals widely take account of QOL. This wide multidimensional concept usually includes self-measures of physical and mental health. QOL is evaluated with general and specific scales. General scales allow to compare QOL of different diseases, when specific scales focus on one disease and consider all aspects related to this disease and therefore are more appropriate and sensitive in dimensions related to patient disease and health. "Facial disability Index" (FDi) and "Facial Clinimetric Evaluation" (FaCE) are the two most used validated questionnaires to assess QOL of patients suffering from peripheral facial palsy (PFP). There is no existing validated questionnaire or scale in French version evaluating QOL of patients with PFP despite many French studies on PFP available. Using these questionnaires in French language requires translation and strict approval of the new language version. The aim of the study is to translate and validate French versions of specific scales of QOL in peripheral facial palsy patients: FDI and FaCE. Secondary objective is to evaluate QOL of patients depending on PFP etiology. Translation process will be done respecting internationally recognized rules. A pilot study will be performed on 5 physicians and 5 patients in order to validate the questionnaires translations. French versions obtained for these 2 questionnaires will be used for their validation on 80 patients suffering from PFP in our hospital. Cronbach's alpha will be estimated to check internal consistency of FDI and FaCE scales. Test re-test reliability will be calculated with inter-class correlation, reiterating questionnaires one week later. Scores of FDI and FaCE scales will be compared to House-Brackmann and Sunnybrook clinical evaluation scales, estimating correlation coefficient. Social function of FDI and FaCE scales will also be compared with general scale SF-36 scores, estimating a correlation coefficient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Facial Paralysis, Quality of Life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
peripheral facial palsy patients
Arm Type
Experimental
Arm Description
peripheral facial palsy patients will performed questionnaires of quality of life ("Facial disability Index" (FDi) and "Facial Clinimetric Evaluation" (FaCE)
Intervention Type
Other
Intervention Name(s)
Facial disability Index" (FDi)
Intervention Description
questionnaires regarding to quality of life
Intervention Type
Other
Intervention Name(s)
"Facial Clinimetric Evaluation" (FaCE)
Intervention Description
questionnaires regarding to quality of life
Primary Outcome Measure Information:
Title
"Facial disability Index" (FDi)
Description
questionnaire to assess the oral, ocular and the influence of facial impairment on emotions and daily activity
Time Frame
one week
Secondary Outcome Measure Information:
Title
Facial Clinimetric Evaluation" (FaCE)
Description
questionnaire to asses facial deficit and disability relating to 6 areas: facial movement, facial comfort, oral function, ocular comfort, tear control and social function
Time Frame
one week
Title
House-Brackmann score
Description
The House-Brackmann score is a score to grade the degree of nerve damage in a facial nerve palsy. The measurement is determined by measuring the upwards (superior) movement of the mid-portion of the top of the eyebrow, and the outwards (lateral) movement of the angle of the mouth. Each reference point scores 1 point for each 0.25 cm movement, up to a maximum of 1 cm. The scores are then added together, to give a number out of 8
Time Frame
one week
Title
Sunnybrook index
Description
clinical evaluation calculating a score depending of Resting Symmetry, Symmetry of Voluntary Movement and Synkinesis
Time Frame
one week
Title
SF-36 score
Description
The Short Form (36) Health Survey is a 36-item. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Pricing depends on the number of scores that the researcher needs to calculate. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health
Time Frame
one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with peripheral facial palsy Age over 18 years old. Subject wishing and able to give informed consent and to respect the requirements of the protocol Exclusion Criteria: Patient not being French. Patient who can not read French. Facial graduation. Facial dysfunction other than PFP such as facial trauma. Major medical or psychiatric illness that, in the opinion of the investigator, would pose a risk to the subject or could compromise compliance with the study protocol. Participation in other studies in the 30 days prior to inclusion in this study. Legal incapacity or limited legal capacity.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MARION MONTAVA, MD
Phone
+33491435618
Email
Marion.MONTAVA@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
CECILE LAVOUTE, PHD
Phone
+33491381878
Email
cecile.lavoute@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EMILIE GARRIDO PRADALIE
Organizational Affiliation
ASSISTANCE PUBLIQUE DES HOPITAUX DE MARSEILLE
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Des Hopitaux de Marseille
City
Marseille
State/Province
Paca
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CECILE LAVOUTE, PHD
Phone
+33491381878
Email
cecile.lavoute@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
MARION MONTAVA, MD

12. IPD Sharing Statement

Learn more about this trial

Validation of a French-language Version of Quality of Life Questionnaires in Patients With Peripheral Facial Palsy

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