TRIAGE: Temple Registry for the Investigation of African American Gastrointestinal Disease Epidemiology

• Sponsor: Temple University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01262755
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 450
• Location: 1
• Duration (Months): 57
• Patients Per Site Per Month: 7.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease; Functional Bowel Disorders	Behavioral: Structured Interview

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 450 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Temple Registry for the Investigation of African American Gastrointestinal Disease Epidemiology
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
African Americans Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.	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.

Outcome Measures

Primary Outcome Measures

1. Epidemiologic Factors Associated With Prevalent Reflux Disease. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140

Sponsors and Collaborators

• Temple University
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Frank K Friedenberg, MD, Temple University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Full reference for project.

Publications

None provided.

• Responsible Party: Frank K. Friedenberg, Professor of Medicine, Temple University
• ClinicalTrials.gov Identifier: NCT01262755
• Other Study ID Numbers: K24DK083268; K24DK083268
• First Posted: Dec 17, 2010
• Last Update Posted: May 4, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Frank K. Friedenberg, Professor of Medicine, Temple University: GERD; IBS; Minority
• Additional relevant MeSH terms: Gastroesophageal Reflux; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Results

Participant Flow

Arm/Group Title	African Americans
Arm/Group Description	Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80. 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.
Period Title: Overall Study
STARTED	450
COMPLETED	450
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	African Americans
Arm/Group Description	Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80. 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.
Overall Participants	450
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.2 (6.6)
Sex: Female, Male (Count of Participants)
Female	272 60.4%
Male	178 39.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	450 100%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	450 100%

Outcome Measures

1. Primary Outcome

Title	Epidemiologic Factors Associated With Prevalent Reflux Disease.
Description	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.
Time Frame	Two years

Outcome Measure Data

Analysis Population Description

Patients successfully identified from targeted area.

Arm/Group Title	African Americans
Arm/Group Description	Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80. 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.
Measure Participants	450
Number (95% Confidence Interval) [percentage of participants with GERD]	17.6 3.9%

Adverse Events

Arm/Group Title	African Americans
Arm/Group Description	Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80. 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.
All Cause Mortality
	African Americans
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	African Americans
	Affected / at Risk (%)	# Events
Total	0/450 (0%)
Other (Not Including Serious) Adverse Events
	African Americans
	Affected / at Risk (%)	# Events
Total	0/450 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.