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临床试验/NCT01262755
NCT01262755已完成不适用

Temple Registry for the Investigation of African American Gastrointestinal Disease Epidemiology

Temple University1 个研究点 分布在 1 个国家目标入组 450 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
450
试验地点
1
主要终点
Epidemiologic Factors Associated With Prevalent Reflux Disease.

研究概览

简要总结

DESCRIPTION: Minimal data exists on the prevalence of gastroesophageal reflux disease in minority populations. Specific objectives of this K24 research project are to: (1) Provide an estimate of the prevalence of gastroesophageal reflux disease in an urban, African American population; (2) Determine whether specific risk factors including diet, tobacco use, physical activity, and psychosocial stress are important in the targeted population. We will also measure height, weight, and waist/hip circumference to determine the impact of central obesity on reflux. PUBLIC HEALTH RELEVANCE: This research will help doctors to understand the frequency and risks for esophageal reflux disease (heartburn) in African Americans.

详细描述

Treatment Plan

The goal of our survey will be to obtain responses from at least 450 self-described African Americans.

Method From our previous study we found that relying on responses from surveys placed in resident mailboxes (which need to be mailed back to us) is ineffective. For this study we have divided the zip code into roughly four equal quadrants using Broad Street and Erie Avenue as dividers. We will place a flyer in 1000 mail boxes in each quadrant by hand delivery. Hand delivery assures that mailings to vacated buildings will not occur. We hand delivered surveys in our previous study and encountered no problems. This will allow for a balanced representation from the entire zip code (see data collection section for further discussion of this point). The flyer informs the participants that the Temple Gastroenterology department is performing a health survey and gives them a phone number to call if they are interested. This phone is in a locked lab run by the PI. As compensation for their time they will receive $25. Only one subject per household is eligible and interviews can be completed at the hospital or in the participant's home. Only those individuals willing to be contacted in future years for follow-up will be enrolled. Subjects must show an identification verifying that their home address is in the zip code (usually a driver's license).

The overall survey consists of several standardized questionnaires which have been organized into a logical, easy to complete, comprehensive unit. Patients will complete the survey on a laptop which contains all the questions in an easy to read and follow Microsoft Access database file. Essentially no computer skills are needed to complete it except for the use of a mouse. A member of the research team will sit in the room to help the subject if there are questions. This survey is password secured such that when the subject completes the survey they cannot access the responses of other subjects. Answering the last question automatically closes the file.

The individual questionnaires making up the overall survey are included in this packet. Initial questions ask the subject their name, address, contact phone numbers and demographic questions such as income and education level. Subsequent questions are the complete set of questions from standardized questionnaires such as AUDIT for alcohol use assessment. The cornerstones of the survey are the 17 question survey on GERD which covers all components of the Montreal classification, and the 65 questions which make up the Rome III functional bowel disease questionnaire. We estimate it will take participants 30-60 minutes to complete depending on age and educational level.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age over 18
  • self-described African American or Caucasian
  • lived in zip code for > 3 years

排除标准

  • newly arrived to zip code
  • unable to provide proof of address
  • unwilling to come to temple to complete interview

结局指标

主要结局

Epidemiologic Factors Associated With Prevalent Reflux Disease.

时间窗: Two years

Patients will complete a series of standardized questionnaires to determine the prevalence of reflux disease and risk factors for its development. We will query diet, depression, drug, tobacco, and alcohol use as well as a variety of other factors. We will study 450 African Americans living in North Philadelphia.

次要结局

未报告次要终点

研究者

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

Frank K. Friedenberg

Professor of Medicine

Temple University

研究点 (1)

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