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临床试验/NCT01162668
NCT01162668已完成不适用

Assessment of Outcomes Following Bariatric Surgery for Mississippi State Employees

University of Mississippi Medical Center4 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
165
试验地点
4
主要终点
Weight loss

研究概览

简要总结

Objective: to assess the health and economic outcomes (weight lost, change in control of chronic diseases such as diabetes, quality of life, work productivity, health care cost, etc) associated with bariatric (weight-loss) surgery for 200 severely obese patients who undergo bariatric surgery as part of the Mississippi State Employees' Life and Health Insurance Plan's Obesity Treatment Program (OTP).

  1. Patient Characteristics: Inclusion criteria: Eligible bariatric surgical candidates who are enrolled in the OTP (100 patients per year for 2 years). The Plan's criteria includes, but is not limited to 1) enrollment in the plan for at least 12 consecutive months prior to September 1, 2009; 2) completion of the HealthQuotient health risk assessment through the Plan's wellness and health promotion program; 3) a Body Mass Index (BMI) of >40 kg/m2, or a BMI >35 kg/m2 with two or more co-morbidities such as diabetes, hypertension, sleep apnea or asthma; 4) two or more physician-supervised weight loss attempts within the last 24 months; 5) age 18 years or older; and 6) consent to provide personal and medical information to the Plan. Prior to surgery, each site administers a psychiatric evaluation to ensure the patient is psychologically stable for surgery. Exclusion criteria: any patient who does not meet criteria above or who declines to participate. Surgeries will take place only at Certified Bariatric Surgery Centers of Excellence (COE), of which, there are currently 3 in the state. The 3 COEs exist with 4 outpatient medical offices (1 COE is composed of 2 independent surgeon practices) Patients will be recruited at each site once they are approved by the OTP.

  2. Design: prospective, observational, multi-center, longitudinal study of outcomes and resource utilization associated with OTP. Estimates of obesity and comorbidities' impact will be obtained from the outpatient medical office for the COEs. Medical charts, databases and medical/pharmacy claims will be the source of information. Surveys on quality of life, productivity, and patient satisfaction will be administered directly to patients. Database claim information will be obtained in future and is not a part of current IRB application.

4: Procedures: After obtaining informed consent, patients will be administered surveys at baseline, as well as at follow-up visits. Additional data will be obtained via patient charts, databases, and medical/pharmacy claims.

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • Eligible bariatric surgical candidates who are enrolled in the Mississippi SSELHI Plan (100 candidates enrolled per year). The Plan's criteria includes, but is not limited to
  • enrollment in the plan for at least 12 consecutive months prior to September 1, 2009
  • completion of the HealthQuotient health risk assessment through the Plan's wellness and health promotion program
  • a Body Mass Index (BMI) of >40 kg/m2, or a BMI >35 kg/m2 with two or more co-morbidities such as diabetes, hypertension, sleep apnea or asthma
  • two or more physician-supervised weight loss attempts within the last 24 months
  • consent to provide personal and medical information to the Plan

排除标准

  • Any patient who does not meet criteria above or who declines to participate.

结局指标

主要结局

Weight loss

时间窗: 0, 6, 12, and 24 months

change in weight from baseline

Body mass index (BMI)

时间窗: 0, 6, 12, and 24 months

Change in body mass index (BMI) from baseline

次要结局

  • Systolic blood pressure(0, 6, 12, and 24 months)
  • ecomonic outcomes(0, 6, 12, and 24 months)
  • Diastolic blood pressure(0, 6, 12, and 24 months)
  • Medication use(0, 6, 12, and 24 months)
  • quality of life(0, 6, 12, and 24 months)
  • Work productivity(0, 6, 12, and 24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katie McClendon

Clinical Assistant Professor

University of Mississippi Medical Center

研究点 (4)

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