Reliability, Validity of the Turkish Version of the Primary Sjögren Syndrome Quality of Life (PSS-QoL) Questionnaire

Sponsor
Gazi University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04858464
Collaborator
(none)
75
1
24
3.1

Study Details

Study Description

Brief Summary

The purpose of this study was to investigate adaptation, validity, and reliability of the Turkish version of the Primary Sjögren's Syndrome Quality of Life (PSS-QoL) Questionnaire

Condition or Disease Intervention/Treatment Phase
  • Other: Survey study

Detailed Description

Primary Sjögren's Syndrome (PSS) is a chronic systemic disease characterized by lymphocytic infiltration of exocrine glands. Dryness, chronic pain, physical fatigue, glandular and extraglandular symptoms seen in PSS cause deterioration of the health-related quality of life.

The Primary Sjögren's Syndrome Quality of Life (PSS-QoL) Questionnaire has recently developed as a patient-reported condition-specific outcome measurement tool to assess the quality of life associated with PSS. The PSS-QoL questionnaire consists of 25 questions with a physical and psychosocial dimension.The physical dimension consists of a numeric rating scale (NRS, ranging from 0 to 10) for pain and physical symptoms. The question related to vaginal dryness is intended to be answered by women only. Each "yes" answer about physical symptoms-related questions adds 1 point to the score. The psychosocial dimension can be scored on a 5-point Likert scale and contains 14 question with the following possible answers: never (0), rarely (1), sometimes (2), often (3), and always (4). The PSS-QoL score ranges from 0-96 (for women) and 0-92 (excluding the question of vaginal dryness for men). After questioning the sociodemographic characteristics of the individuals, PSS-QoL, EuroQuol-5D, the EULAR Sjögren's Syndrome Disease Activity Index and EULAR Sjögren's Syndrome Patient Reported Index will be used. Test-retest will be re-applied to those of the same individuals who can be reached after 1 week. The results will be analyzed using the SPSS version 22.0 computer package program.

Study Design

Study Type:
Observational
Anticipated Enrollment :
75 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Reliability, Validity, and Cross-Cultural Adaptation of the Turkish Version of the Primary Sjögren Syndrome Quality of Life (PSS-QoL) Questionnaire
Actual Study Start Date :
May 2, 2021
Anticipated Primary Completion Date :
May 2, 2023
Anticipated Study Completion Date :
May 2, 2023

Arms and Interventions

Arm Intervention/Treatment
Patients group

Individuals with primary Sjögren's syndrome

Other: Survey study
Patients will complete the mentioned questionnaires.
Other Names:
  • Questionnaire application
  • Outcome Measures

    Primary Outcome Measures

    1. Primary Sjögren's Syndrome Quality of Life (PSS-QoL) Questionnaire [10 minutes]

      Primary Sjögren's Syndrome Quality of Life (PSS-QoL) Questionnaire was designed to evaluate measurement of health related quality of life in patients with primary Sjögren's syndrome.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Diagnosed with primary Sjögren's syndrome
    Exclusion Criteria:
    • Having neurological and cognitive disorders,

    • Having another rheumatological diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gazi University Ankara Turkey

    Sponsors and Collaborators

    • Gazi University

    Investigators

    • Study Director: Deran Oskay, Assoc. Prof, Gazi University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Selin Bayram, Msc, Gazi University
    ClinicalTrials.gov Identifier:
    NCT04858464
    Other Study ID Numbers:
    • E-77082166-604.01.02-27503
    First Posted:
    Apr 26, 2021
    Last Update Posted:
    Sep 8, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Selin Bayram, Msc, Gazi University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 8, 2021