NCT04858464

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

May 2, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2023

Completed
Last Updated

September 8, 2021

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

April 21, 2021

Last Update Submit

August 31, 2021

Conditions

Keywords

Primary Sjögren's SyndromeQuality of LifePatient-reported OutcomeReliabilityValidity

Outcome Measures

Primary Outcomes (1)

  • Primary Sjögren's Syndrome Quality of Life (PSS-QoL) Questionnaire

    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

Study Arms (1)

Patients group

Individuals with primary Sjögren's syndrome

Other: Survey study

Interventions

Patients will complete the mentioned questionnaires.

Also known as: Questionnaire application
Patients group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Diagnosed with primary Sjögren's syndrome

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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.

    PMID: 29395257BACKGROUND
  • 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.

    PMID: 20147445BACKGROUND
  • 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.

    PMID: 28182787BACKGROUND

MeSH Terms

Interventions

Longitudinal Studies

Intervention Hierarchy (Ancestors)

Cohort StudiesEpidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Deran Oskay, Assoc. Prof

    Gazi University

    STUDY DIRECTOR

Central Study Contacts

Selin Bayram, Msc

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc

Study Record Dates

First Submitted

April 21, 2021

First Posted

April 26, 2021

Study Start

May 2, 2021

Primary Completion

May 2, 2023

Study Completion

May 2, 2023

Last Updated

September 8, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations