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

NCT ID: NCT04858464

Last Updated: 2021-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-02

Study Completion Date

2023-05-02

Brief Summary

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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

Detailed Description

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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.

Conditions

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Primary Sjögren's Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients group

Individuals with primary Sjögren's syndrome

Survey study

Intervention Type OTHER

Patients will complete the mentioned questionnaires.

Interventions

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Survey study

Patients will complete the mentioned questionnaires.

Intervention Type OTHER

Other Intervention Names

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Questionnaire application

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with primary Sjögren's syndrome

Exclusion Criteria

* Having neurological and cognitive disorders,
* Having another rheumatological diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Selin Bayram

Msc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deran Oskay, Assoc. Prof

Role: STUDY_DIRECTOR

Gazi University

Locations

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Gazi University

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Selin Bayram, Msc

Role: CONTACT

05327001805

Facility Contacts

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Selin Bayram, Msc

Role: primary

References

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Lackner A, Stradner MH, Hermann J, Unger J, Stamm T, Graninger WB, Dejaco C. Assessing health-related quality of life in primary Sjogren's syndrome-The PSS-QoL. Semin Arthritis Rheum. 2018 Aug;48(1):105-110. doi: 10.1016/j.semarthrit.2017.11.007. Epub 2017 Nov 27.

Reference Type BACKGROUND
PMID: 29395257 (View on PubMed)

Ng WF, Bowman SJ. Primary Sjogren's syndrome: too dry and too tired. Rheumatology (Oxford). 2010 May;49(5):844-53. doi: 10.1093/rheumatology/keq009. Epub 2010 Feb 10.

Reference Type BACKGROUND
PMID: 20147445 (View on PubMed)

Lackner A, Ficjan A, Stradner MH, Hermann J, Unger J, Stamm T, Stummvoll G, Dur M, Graninger WB, Dejaco C. It's more than dryness and fatigue: The patient perspective on health-related quality of life in Primary Sjogren's Syndrome - A qualitative study. PLoS One. 2017 Feb 9;12(2):e0172056. doi: 10.1371/journal.pone.0172056. eCollection 2017.

Reference Type BACKGROUND
PMID: 28182787 (View on PubMed)

Other Identifiers

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E-77082166-604.01.02-27503

Identifier Type: -

Identifier Source: org_study_id

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