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Validation of the French Version of the Xerostomia Inventory (XIvf)

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ClinicalTrials.gov Identifier: NCT03009786
Recruitment Status : Recruiting
First Posted : January 4, 2017
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Tracking Information
First Submitted Date December 27, 2016
First Posted Date January 4, 2017
Last Update Posted Date December 31, 2018
Actual Study Start Date May 5, 2017
Estimated Primary Completion Date November 5, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 2, 2017)
The psychometric properties of the Xerostomia Inventory measured by questionnaire [ Time Frame: month 6 ]
The Xerostomia Inventory to be validated is an 11-item summated rating scale which combines the responses to 11 individual items into a single continuous scale score which represents the severity of chronic xerostomia; higher scores represent more severe symptoms. Respondents are asked to choose one of five responses: Never: 1 point; Hardly ever: 2 points; Occasionally: 3 points; Fairly often: 4 points; Very often: 5 points; to the following statements referring to the previous 4 weeks.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03009786 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validation of the French Version of the Xerostomia Inventory
Official Title Cross-cultural and Psychometric Validation Version of the Xerostomia Inventory Into French Language
Brief Summary The main objective of this study is to achieve cross-cultural and psychometric validation of the Xerostomia Inventory initially developed in English language into French Language. This will be achieved in two stages: First, cross-cultural validation, and a second, psychometric validation The cross-cultural validation will be performed according to the methodology of the Institute for Work and Health, according to the recommended six phases. In a second step, the psychometric validation will be done using longitudinal study. Indeed, an observational, longitudinal, and prospective study will be set up. Analysis of the results will help define the feasibility and acceptability of the tool, its validity (content validity, perceived validity, construct validity, concurrent validity, and discriminant validity), its reliability (internal consistency and reproducibility over time). Longitudinal follow-up of patients is expected to also assess the predictive validity and responsiveness.
Detailed Description

Medical context:

There is an intra-individual and inter-individual variability in the production of saliva. Various factors influence the production of saliva. Saliva flow tends to decrease with age, sleep, emotional state, and to increase after eating, and during pregnancy. Some drugs increase the salivary flow, others decrease it. Tobacco and alcohol tend to impair the quality of the saliva. Furthermore, 43% of 40-64 years and 61% over 65 take at least one antisialic medication. Lack of saliva can cause problems chewing, swallowing, speaking, and tasting perceptions. There is an increase in the number of oropharyngeal candidiasis that affects feeding behaviors and would be responsible for malnutrition in the elderly, and an increase in the number of caries for subjects still toothed. For edentulous or partially dentate subjects, salivary film plays two roles: the first is to allow adhesion of complete or almost complete dentures; the following is to protect the oral mucosa. In subjects suffering from mouth dryness the denture becomes difficult. In addition, saliva is essential for the first phase of digestion, for the creation of a correct bolus. There are several methods to measure the salivary flow. The most common include:

  • The measurement of salivary flow at rest, the subject leaves the saliva in his mouth then allowed to flow slowly and spit into a funnel connected to a graduated tube for either 6 or 12 minutes. This test can be performed either at rest or stimulated using a paraffin cube or citric acid. These tests are long and therefore not suitable for the elderly.
  • The salivary flow measurements using a compress weight of about 0.95 g is weighed and then placed under the tongue of the subject for 5 minutes. Once the elapsed time, the pad is weighed, a simple subtraction determines the weight of saliva produced in 5 minutes. This test can be done like the previous one at rest or after stimulation.

Secretion at rest varies authors 0,05mℓ / min 0,4mℓ / min. The mouth dryness is defined by a total salivary flow rate below 0.1 unstimulated +/- 0,1mℓ / min ≤ 0.16 mℓ / min. The salivary potential of hydrogen (pH) varies between 6.5 and 8.5. Decreased salivary flow will cause a decrease in pH and promote the degradation of the oral health status.

Tool: The Xerostomia Inventory is a scale of measurement of xerostomia with eleven items used in daily practice or research, which results in a sum score giving a score representing the severity of the drought oral perceived by the subject. This tool was developed in 1999 and covers both experimental and behavioral aspects of xerostomia, and showed acceptable psychometric characteristics. Today, this tool is available in English, Spanish and Portuguese languages With this study a tool to measure xerostomia will be available in French; it may be used in clinical studies and in the daily practice of the dentist and or speech therapists to obtain a subjective measure of dry mouth, particularly in the elderly who are the most vulnerable subjects consequences of xerostomia. Currently there is no way to measure xerostomia, it is difficult to assess the processes associated with the patient and case treatment administered it is impossible to say whether it is effective or not.

The aim of this study is to achieve cross-cultural and psychometric validation version of the Xerostomia Inventory into French Language.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Elderly institutionalized subjects or outpatients aged 65 years or over
Condition Xerostomia
Intervention Other: Measurement of salivary flow
A compress of about 0.95 g which is weighed and then placed under the tongue of the subject for 5 minutes. Once the time has elapsed, the compress is weighed, a simple subtraction determines the weight of saliva produced in 5 minutes
Study Groups/Cohorts Elderly institutionalized subjects or outpatients
Intervention: Other: Measurement of salivary flow
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 2, 2017)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2021
Estimated Primary Completion Date November 5, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age: 65 years or more
  • Outpatients or nursing home residents
  • Speaking French fluently
  • Willing to participate to the study

Exclusion Criteria:

  • Incapability to understand the instructions or to fill alone the questionnaire
  • Under guardianship
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Pierrard Loïc 326787878 ext 0033 docteur.pierrard@gmail.com
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03009786
Other Study ID Numbers PO16109
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party CHU de Reims
Study Sponsor CHU de Reims
Collaborators Not Provided
Investigators Not Provided
PRS Account CHU de Reims
Verification Date December 2018