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

August 31, 2021 updated by: Selin Bayram, Gazi University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Gazi University
        • Contact:
          • Selin Bayram, Msc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with primary Sjögren's syndrome between the ages of 18-90

Description

Inclusion Criteria:

  • Diagnosed with primary Sjögren's syndrome

Exclusion Criteria:

  • Having neurological and cognitive disorders,
  • Having another rheumatological diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients group
Individuals with primary Sjögren's syndrome
Other: Survey study
Patients will complete the mentioned questionnaires.
Other Names:
  • Questionnaire application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Sjögren's Syndrome Quality of Life (PSS-QoL) Questionnaire
Time Frame: 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.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 2, 2021

Primary Completion (ANTICIPATED)

May 2, 2023

Study Completion (ANTICIPATED)

May 2, 2023

Study Registration Dates

First Submitted

April 21, 2021

First Submitted That Met QC Criteria

April 21, 2021

First Posted (ACTUAL)

April 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 8, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-77082166-604.01.02-27503

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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