An Observational Study of Patients With Metabolic Syndrome and Related Conditions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,000,000
- 主要终点
- To characterize the natural history of disease in patients with metabolic syndrome and related conditions
研究概览
简要总结
TARGET-METABOLIC is an observational research study to conduct a comprehensive review of outcomes for patients with metabolic syndrome and related conditions.
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 metabolic syndrome or related conditions by ICD-10 code or with clinically calculated BMI ≥ 30 in the EHR/health system 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
- •Exclusion Criteria:
- •Patient 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
结局指标
主要结局
To characterize the natural history of disease in patients with metabolic syndrome and related conditions
时间窗: 15 Years
A detailed analysis of available demographics, anthropometric characteristics, glycemic metrics, medications, co-morbidities, and medical history from sites across the US will inform the profile for various patient populations enrolled into the study. Collection of detailed medical records will be curated and analyzed to characterize disease natural history, clinical course of disease, number and types of interventions, current treatment paradigms, and the patient diagnostic journey. 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 to characterize the clinical course of disease. The progression of pre-existing co-morbidities and variances across populations will also be evaluated.
To assess safety and effectiveness of treatments for metabolic syndrome and related conditions.
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 metabolic syndrome and related conditions. Treatments may be pharmacologic, surgical, procedures, radiologic or other interventions given to change the disease course/outcomes. Interval disease and medical events may vary depending on the patient's stage and type of disease and extent of co-morbidities at study entry and time of diagnosis.
次要结局
- To evaluate provider management practices in the treatment of patients with metabolic syndrome and related conditions(15 Years)
- To evaluate longitudinal and patient reported outcomes in patients with metabolic syndrome and related conditions(15 Years)
- To select and evaluate quality of care measures for patients with metabolic syndrome and related conditions(15 Years)