Defining the Informational Needs of Patients With Sjögren's Syndrome and Development of a Sjögren's Syndrome-specific Informational Needs Questionnaire (SS-INQ)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 1
- 主要终点
- Determine information needs of patients with SS and develop a new questionnaire
研究概览
简要总结
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.
详细描述
This is a PhD student project that will be undertaken in 2 distinct phases.
Phase 1:
Determination of Informational Needs (Months 0- 9)
- Qualitative interviews with patients with SS
- Interview transcriptions and thematic analysis
Subjects The perspective of the patient is critical in the determination of the informational needs of patients with SS. Qualitative interviews will be conducted patients with SS. Due to the depth of rich data that can be derived from focus groups we plan on using this method of qualitative interview.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients with SS who have developed lymphomatous chang
结局指标
主要结局
Determine information needs of patients with SS and develop a new questionnaire
时间窗: 3 years
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
次要结局
未报告次要终点