Validation of the French Version of the Xerostomia Inventory

NCT03009786 | Completed

• 1 other identifier: PO16109*
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Xerostomia

Outcome Measures

Primary Outcomes (1)

• The psychometric properties of the Xerostomia Inventory measured by questionnaire

  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.

  month 6

Study Arms (1)

Elderly institutionalized subjects or outpatients

Other: Measurement of salivary flow

Interventions

Measurement of salivary flow OTHER

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

Elderly institutionalized subjects or outpatients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly institutionalized subjects or outpatients aged 65 years or over

You may qualify if:

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

You may not qualify if:

• Incapability to understand the instructions or to fill alone the questionnaire
• Under guardianship

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: January 4, 2017
• Study Start: May 5, 2017
• Primary Completion: October 27, 2020
• Study Completion: February 20, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

FR (1)