Temple Registry for the Investigation of African American Gastrointestinal Disease Epidemiology

Gastroesophageal Reflux Disease Clinical Trial

— TRIAGE  

Official title:

Temple Registry for the Investigation of African American Gastrointestinal Disease Epidemiology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01262755
• Other study ID #: K24DK083268
• Secondary ID: K24DK083268
• Status: Completed
• Phase: N/A
• First received: December 16, 2010
• Last updated: April 16, 2015
• Start date: April 2010
• Est. completion date: January 2015

Study information

• Verified date: April 2015
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age over 18

• self-described African American or Caucasian

• lived in zip code for > 3 years

Exclusion Criteria:

• newly arrived to zip code

• unable to provide proof of address

• unwilling to come to temple to complete interview

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Bowel Disorders
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Gastrointestinal Diseases
• Intestinal Diseases

Intervention

Behavioral:
• Structured Interview
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.

Locations

Country	Name	City	State
United States	Temple University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epidemiologic Factors Associated With Prevalent Reflux Disease.	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.	Two years	No

External Links

•   Full reference for project.