Multicenter Collection of Uniform Data on Patients With Cognitive Impairment in the Philippines: the Philippine Neurological Association One Database -Dementia (PNA1DB-Dementia)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 73
- 试验地点
- 11
- 主要终点
- Frequency of dementia and mild cognitive impairment in the study population
研究概览
简要总结
This is a pragmatic, multi-center, prospective, observational, non-interventional study and standing database of patients seen at the training institution for cognitive impairment diagnosed with Mild Cognitive Impairment (MCI) or Dementia.
All patients seen at the training institution clinically diagnosed with MCI or dementia by their neurologists will be invited to participate in the study. The investigators will confirm the diagnosis and will explain the study as well as the patient information sheet to the patient and/or legal representative. All eligible patients seen will be assigned a study identification number. Data will be collected by the investigators as the patient undergoes routine clinical evaluation. Corresponding anonymized data on demographics, medical history and risk factors, level of functional impairment, diagnosis, baseline cognitive scores and management will be collected from each patient and entered in the database using a secure online data collection tool.
详细描述
The investigators will confirm the diagnosis and will explain the study as well as the patient information sheet to the patient and/or legal representative. All eligible patients seen will be assigned a study identification number. Data will be collected by the investigators as the patient undergoes routine clinical evaluation. Corresponding anonymized data on demographics, medical history and risk factors, level of functional impairment, diagnosis, baseline cognitive scores and management will be collected from each patient and entered in the database using a secure online data collection tool. Patients who withdraw participation verbally or in writing are excluded by the investigator from further participation. Withdrawal from the study will be properly documented, including date, time, and reason for withdrawal. Withdrawn subjects will not have their clinical data included in the database.
Collective data will be extracted, summarized, and analyzed every year with oversight provided by the Philippine Neurological Association (PNA). To be able to assess trends and changes over time, data collection for this study will span 3 years from study initiation, after which the utility of an extension or a re-implementation of the study will be assessed by the PNA.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Frequency of dementia and mild cognitive impairment in the study population
时间窗: on Day 1
To determine the frequency of dementia and mild cognitive impairment in the study
次要结局
- Diagnostic tests used at the time of the diagnosis(on Day 1)
- Demographic characteristics of patients with dementia or mild cognitive impairment(on Day 1)
- Dementia Severity(on Day 1)
- Pharmacologic and nonpharmacologic modalities used(on Day 1)
- F frequency of the different types of dementia in the study population(on Day 1)
- Frequency of risk factors for dementia in the study population(on Day 1)