Italian Translation and Validation of the GIDS-PD Scale for Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 190
- 试验地点
- 5
- 主要终点
- Translation the Italian version of GIDS-PD
研究概览
简要总结
This study aims to translate and validate the Gastrointestinal Dysfunction Scale for Parkinson's Disease (GIDS-PD) into Italian to enable the assessment of gastrointestinal symptoms in Italian-speaking patients with Parkinson's disease. The psychometric properties of the translated instrument will be evaluated through a multi-phase process involving translation/back-translation, pre-testing, and large-scale validation across multiple Italian centers
详细描述
Gastrointestinal dysfunction is a frequent and burdensome non-motor feature of Parkinson's disease, yet validated tools to measure these symptoms are not available for Italian-speaking patients. The study will will undergo three distinct phases, as specified by the MDS guidelines (International Parkinson and Movement Disorder Society, 2023): translation and back-translation (Phase I), pre-test (Phase II), large-scale validation test (Phase III).
- Phase I The translation and back-translation process will be conducted by two independent teams; one team will translate the content from English to Italian, followed by another team independently back-translating it from Italian to English (back-translation).
- Phase II Phase II will involve about 10 PD patients, as heterogeneous as possible, from different Italian regions, and 10 clinicians (PD nurses, neurologists, etc) examiners. The instrument, in this preliminary version, will be presented to a group of about 10 PD patients for the pre-test phase. This phase will be used to establish the basic psychometric properties of the scale and identify items that could potentially be culturally complex.
- Phase III Once the official translation has been approved, the instrument will be administered to a sample of PD patients, native Italian speakers, heterogeneous as far as possible in age and gender.
The final Italian version will be assessed for data quality, acceptability, construct validity, and reliability in a cohort of patients diagnosed with Parkinson's disease across multiple Italian centers.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Diagnosis of PD according to the Movement Disorder Society (MDS) diagnostic criteria (Postuma RB et al., 2015);
- •Italian-native patients or patients that understand Italian correctly at least;
- •Participants mentally and physically able to understand and sign the informed consent form.
排除标准
- •Persons in the terminal phase of disease;
- •Persons with clinically relevant cognitive impairment;
- •Persons diagnosed with Parkinsonism other than PD.
结局指标
主要结局
Translation the Italian version of GIDS-PD
时间窗: 3 years
Score on the Italian version of the Geriatric Impulse Dyscontrol Scale-Parkinson's Disease (GIDS-PD), total score ranging from 0 to 100, with higher scores indicating greater impulse control difficulties.
次要结局
未报告次要终点