Temple Registry for the Investigation of African American Gastrointestinal Disease Epidemiology
Condition: Gastroesophageal Reflux Disease; Functional Bowel Disorders
MeSH terms: Gastroesophageal Reflux; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.

      Risks.

      The only potential risk is related to confidentiality. Sensitive personal information is
      assessed using the survey. Several levels of subject protection will be employed. These
      include use of a password protected file for database collection on a computer which is
      password protected when turned off. The computer will be kept in a locked office in the
      hospital. The phone used to interact with subjects is in lab #7 of the Parkinson Pavilion,
      10th floor.

      There are no interventions to be performed for this study. There will be, for example, no
      blood draws. Future studies may recruit individuals from this database for invasive
      diagnostic testing and further data collection but those will be covered under future IRB
      submissions.

      Benefits

      Subjects who participate in the study will develop a greater insight into the possible causes
      of their medical problem. In a relaxed environment will they have the opportunity to talk
      with a board-certified gastroenterologist about their health. They will be provided with
      accurate information and will be encouraged to engage the health care system by communicating
      with their primary care physician. The African American community as a whole will benefit
      tremendously as their health status within the US is presented in peer-reviewed literature.
      This has the potential to shape public policy. Future studies under separate IRB protocols
      may provide benefit to them such as free testing for potentially serious GI diseases.

      Data Collection and Statistics

      We will recruit a minimum of 100 African Americans from each quadrant of the zip code 19140
      with the total adding to 450.
    

Intervention name(s): Structured Interview
Intervention type(s): Behavioral
Intervention description(s): Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All adult individuals (age 18-80)residing in the 19140 zip code area will be eligible for
        participation. We will interview 750 African American residents and 250 self-described
        Caucasian residents.
      
Keywords: GERD; IBS; Minority