An Observational Study of Patients Living With Chronic Neurological Diseases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,500,000
- 主要终点
- To characterize the natural history of disease in patients living with chronic neurological diseases including ADRD, MCI, PD, or MS
研究概览
简要总结
TARGET-NEURO is an observational research study to conduct a comprehensive review of outcomes for patients living with chronic neurological diseases: Alzheimer's disease and related dementia (ADRD), mild cognitive impairment (MCI), Parkinson's disease (PD), and multiple sclerosis (MS).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Adult patients at the time of enrollment with a diagnosis of ADRD, MCI, PD, or MS by select ICD-10 codes in the EHR interface
排除标准
- •Manual removal (sponsor or site request)
- •No EHR interface encounter > 3 years
- •Engaged Cohort
- •Inclusion Criteria:
- •Adult patients diagnosed and managed for these conditions invited to participate
- •Ability to provide written informed consent (or have a legally authorized representative to provide informed consent)
- •Care partners may be invited to participate in surveys and will provide informed consent.
- •Exclusion Criteria:
- •Patient expressed desire to withdraw consent to complete PROs
- •Care partner expressed desire to withdraw consent to complete PROs
- •Failure to complete PROs within 24 weeks of initial invitation
- •Greater than 24 months lapse of survey completion after baseline surveys completed
- •Additionally, the criteria detailed for Disease Cohort apply to the Engaged Cohort
- •Inclusion Criteria:
- •Adult patients aged 60 and older at time of enrollment
- •Exclusion Criteria:
- •Manual removal (sponsor or site request)
- •No EHR interface encounter > 3 years
结局指标
主要结局
To characterize the natural history of disease in patients living with chronic neurological diseases including ADRD, MCI, PD, or MS
时间窗: 15 Years
A detailed analysis of available demographics (age, race, sex, country of birth, insurance status), medications, co-morbidities, and medical history from sites across the US will inform the profile for this patient population. Data from retrospective and prospectively collected medical records will be curated and analyzed to characterize disease natural history and current treatment paradigms. These data may also establish incidence rates of events of special interest. Collection of prospective medical records for each patient enables the continuation of these analyses longitudinally for changes and progression. Part of the characterization of disease or living with a chronic disease may also be informed by patient reported outcome (PRO) measures and care partner surveys.
To assess safety and effectiveness of disease treatments and treatments for complications of patients receiving various treatments, effectiveness of treatment, and medical events that develop while receiving treatment for ADRD, MCI, PD, or MS.
时间窗: 15 Years
The study will evaluate the characteristics of patients receiving various treatments, effectiveness of treatment, and medical events that develop while receiving treatment for ADRD, MCI, PD, or MS. Interval disease and medical events may vary depending on the patient's stage and type of disease and extent of co-morbidities. The progression of pre-existing co-morbidities and variances across populations will also be evaluated. The type, dose and duration of disease-specific therapies will be closely followed with a goal of monitoring treatment paradigms and various combination regimens for clinical response and disease stabilization/progression.
次要结局
- 3. To select and evaluate quality of care measures for patients living with ADRD, MCI, PD, or MS(15 Years)
- To evaluate longitudinal and patient and care partner reported outcomes in patients with ADRD, MCI, PD, or MS, including care partner burden and quality of life.(15 Years)
- To evaluate provider management practices in the treatment of patients living with ADRD, MCI, PD, or MS(15 Years)