Trial Outcomes & Findings for Temple Registry for the Investigation of African American Gastrointestinal Disease Epidemiology (NCT NCT01262755)

NCT ID: NCT01262755

Last Updated: 2015-05-04

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

450 participants

Primary outcome timeframe

Two years

Results posted on

2015-05-04

Participant Flow

Participant milestones

Participant milestones
Measure
African Americans
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 Study
STARTED
450
Overall Study
COMPLETED
450
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Temple Registry for the Investigation of African American Gastrointestinal Disease Epidemiology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
African Americans
n=450 Participants
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.
Age, Continuous
43.2 years
STANDARD_DEVIATION 6.6 • n=39 Participants
Sex: Female, Male
Female
272 Participants
n=39 Participants
Sex: Female, Male
Male
178 Participants
n=39 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=39 Participants
Race (NIH/OMB)
Asian
0 Participants
n=39 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=39 Participants
Race (NIH/OMB)
Black or African American
450 Participants
n=39 Participants
Race (NIH/OMB)
White
0 Participants
n=39 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=39 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=39 Participants
Region of Enrollment
United States
450 participants
n=39 Participants

PRIMARY outcome

Timeframe: Two years

Population: Patients successfully identified from targeted area.

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.

Outcome measures

Outcome measures
Measure
African Americans
n=450 Participants
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.
Epidemiologic Factors Associated With Prevalent Reflux Disease.
17.6 percentage of participants with GERD
Interval 16.4 to 18.8

Adverse Events

African Americans

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Frank Friedenberg, MD

Temple University

Phone: 215-707-9900

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place