ISRCTN61164781进行中(未招募)未知
A novel approach to clinical practice by using a shared decision-making model to target cardiovascular risk: The YANKEES (Your demographics, Adherence, Nutrition, Knowledge, Environment, E-EtOH [alcohol], Smoking, Sleep-quality) study
ew York State Department of Health0 个研究点目标入组 600 人开始时间: 2019年10月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Ambulatory clinic patients that have an established record with a history of two appointments and follow-ups
- •2. Age 18 years and above
- •3. Hypertension, medical diagnosis with no more than three anti-hypertensive medications
- •4. Medical diagnosis of Diabetes Mellitus with hemoglobin A1c less than or equal to 8.0%
- •5. Calculated Body Mass Index between 25 kg/m2 and 40 kg/m2
排除标准
- •1. Unable to provide informed consent in either English or Spanish for any reason, including cognitive impairment, psychiatric illness, drug or alcohol intoxication
- •2. Pregnant or are planning to become pregnant within the year
- •3. Participating in other trials, e.g. weight loss study
- •4. Prior history or present medical condition and/or surgical procedure related to the primary gastrointestinal tracts and/or accessory digestive organs affecting the transit or absorption of ingested nutrients, including but not limited to bariatric, pancreatic disease and multiple bowel surgeries
- •5. Severe comorbid diseases that can lead to unintentional weight change including cancer, HIV/AIDS, autoimmune disease, including and not limited to inflammatory bowel disease, in addition to chronic kidney disease, chronic liver disease and chronic heart disease
- •6. Severe disease, a terminal illness, be incapacitated (including stroke, myocardial infarction, coronary artery disease) with an expected limited life-span of less than a year
- •7. Living in an institutional setting (including nursing home, prison or group home)
- •8. Lab value abnormalities that preclude from participation in study interventions (i.e. significant anemia; derangement in electrolytes; elevation in liver function test; etc.) determined by the Investigator
- •9. Abnormalities in electrocardiogram studies, unless reviewed and cleared by a physician
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