Gastroesophageal Reflux DiseaseTRIAGENCT01262755
Temple Registry for the Investigation of African American Gastrointestinal Disease Epidemiology
An observational study of Gastroesophageal Reflux Disease and Functional Bowel Disorders, run by Temple University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease, Functional Bowel Disorders
- What is being tested?
- Structured Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jan 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- age over 18
- self-described African American or Caucasian
- lived in zip code for > 3 years
Who cannot join
- newly arrived to zip code
- unable to provide proof of address
- unwilling to come to temple to complete interview
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
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.
Read the 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.
- Being tested
- Structured Interview
- Keywords
- GERD, IBS, Minority
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured InterviewBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| African Americans | Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80. Receives: Behavioral: Structured Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank K. Friedenberg, Temple University
- Investigators
- Frank K Friedenberg, MD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262755
- Sponsor's protocol ID
- K24DK083268
- Other IDs
- K24DK083268
- Acronym
- TRIAGE
- Status last verified
- Apr 2015
- First submitted
- 16 Dec 2010
- Last updated
- 4 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temple Registry for the Investigation of African American Gastrointestinal Disease Epidemiology
- ClinicalTrials.gov ID
- NCT01262755
- Acronym / sponsor ID
- TRIAGE / K24DK083268
- Keywords
- GERD, IBS, Minority
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Apr 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Posted 4 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| African Americans | – | Behavioral: Structured InterviewConsists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- age over 18
- self-described African American or Caucasian
- lived in zip code for > 3 years
Key exclusion criteria (3 listed)
- newly arrived to zip code
- unable to provide proof of address
- unwilling to come to temple to complete interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured InterviewSubjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured. | Behavioural | African Americans |
Primary outcome
Epidemiologic Factors Associated With Prevalent Reflux Disease.
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank K Friedenberg, MD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease and Functional Bowel Disorders, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiologic Factors Associated With Prevalent Reflux Disease. (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2015.