SS-INQ Information Needs Questionnaire in Sjögren's Syndrome

NCT04798911 | Completed

• 1 other identifier: 226947
• Study Type: observational
• Target: 243
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with some long-standing rheumatic diseases have stated that they want to be fully informed about their disease as they find it 'more scary not to know' about possible complications and consequences. Patients who have the information they want about their disease can fully take part in decisions about their own health creating a partnership with their doctor. Sjögren's Syndrome (SS) is a multi-system, long-standing rheumatic disease that has a negative impact on the daily life of patients. A common presentation of this disease is dry mouth, which can make talking, eating and swallowing more difficult. Project aims: We aim to ask patients with SS what information they think it would be important to know about SS. We plan to create a questionnaire that can be used by doctors to help deliver the right information to patients at hospital visits. Timescale: This project will take 36 months to complete. Clinical relevance: This questionnaire could be used in daily practice. It could help patients cope with their disease, take part in treatment decision and reduced uncertainty and distress.

Conditions

Sjögren's Syndrome

Outcome Measures

Primary Outcomes (1)

• Determine information needs of patients with SS and develop a new questionnaire

  Qualitative interviews with patients with SS Interview transcriptions and thematic analysis Adaptation of TINQ-BC for use in patients with SS - generation of relevant questions using themes from Phase 1 qualitative study (removal of those solely related to breast cancer from TINQ-BC) by the expert group Pilot testing of SS-INQ for content and readability will be done via focus groups whilst structural validity will be explored using factor analysis Testing of SS-INQ for reliability - internal consistency reliability and test-retest reliability

  3 years

Study Arms (2)

Observational - phase 1

Determination of Informational Needs (Months 0- 9) * Qualitative interviews with patients with SS * Interview transcriptions and thematic analysis

Other: Phase 1 Observational Interviews

Observational - phase 2

Phase 2 Development of the informational need instrument for SS \[SS-INQ\] (Months 9-32) * Adaptation of TINQ-BC for use in patients with SS - generation of relevant questions using themes from Phase 1 qualitative study (removal of those solely related to breast cancer from TINQ-BC) by the expert group * Pilot testing of SS-INQ for content and readability will be done via focus groups whilst structural validity will be explored using factor analysis * Testing of SS-INQ for reliability - internal consistency reliability and test-retest reliability

Other: Phase 1 Observational Interviews

Interventions

Phase 1 Observational Interviews OTHER

Qualitative interviews with patients with SS

Observational - phase 1; Observational - phase 2

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sjögren's Syndrome above 18 years old.

You may qualify if:

• Adult patients with a diagnosis of primary SS as per the 2002 American-European Consensus Group (AECG) classification criteria, or
• Adult patients with a diagnosis of primary SS as per the 2016 American College of Rheumatology/European League Against Rheumatism classification criteria
• Adults with the capacity to consent to their involvement in the study
• Willingness to participate in focus groups
• Fluency in the English language to allow participation in focus group discussion
• Willingness to complete the newly developed questionnaire on at least on occasion

You may not qualify if:

• Patients with SS who have developed lymphomatous chang

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospitals NHS Foundation Trust

London, NW1 2BU, United Kingdom

Location

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 15, 2021
• Study Start: October 12, 2018
• Primary Completion: July 21, 2021
• Study Completion: July 21, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)