AsthmaNCT00281138
Center for Reducing Asthma Disparities - Rhode Island/Puerto Rico Centers
An observational study of Asthma and Lung Diseases, run by Rhode Island Hospital.
Trial summary
To reduce disparities in asthma among Latino children. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Asthma, Lung Diseases
- How many people
- 983 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with asthma or a history of breathing problems, from Non-Latino white, Puerto Rican or Dominican ethnicities. Participant recruitment occurred in Rhode Island and in island Puerto Rico.
- Diagnosed asthma or history of breathing problems (coughing, wheezing, shortness of breath) in the 12 months prior to study enrollment; 2) Non-Latino white, Puerto Rican or Dominican ethnic background; 3)ages 7-15 years
About this study
Official title: Pediatric Asthma Disparities: Perceptions and Management
To reduce disparities in asthma among Latino children.
Read the detailed description
BACKGROUND:
Asthma is a serious chronic condition affecting over 14 million Americans, but the prevalence rates are higher in certain populations (e.g. 10 percent in inner-cities and 30 percent among the homeless vs. 5 percent in a general population of whites). African Americans and Hispanics from the Northeast are twice as likely to die from asthma as whites. African Americans are four times as likely to be hospitalized for asthma and are five times more likely than whites to seek care for asthma at an emergency department. Reasons for these higher rates are not certain, and most likely result from an interaction of risk factors such as environmental exposures, genetic predisposition, access to appropriate medical care, socioeconomic status, and cultural health practices. The National Heart, Lung, and Blood Institute supports a variety of activities to address the pressing public health problems posed by asthma. However, progress in reducing disparities has been disappointingly slow. Separate, independent research projects have generated important clues for understanding the nature and scope of the problem. A more coordinated, interdisciplinary and comprehensive approach to research is needed to take advantage of these clues, move the science further and faster, and increase our capacity to improve health outcomes among minority and economically disadvantaged populations. Cooperative centers of research that foster partnerships among minority medical centers, research intensive institutions, and the communities in which asthma patients live will promote such advancement.
The Request for Applications for the Centers for Reducing Asthma Disparities was released in October, 2001. The objective of the program is to promote partnerships (called Centers) between a minority serving institution (MSI) that may not have a strong research program and a research intensive institution (RII) that has a track record of NIH-supported research and patient care. The purpose of the partnership is to conduct collaborative research on asthma disparities (i.e. greater prevalence of asthma, higher rates of morbidity due to asthma, and lesser access or use of quality medical care among minorities and poor).
DESIGN NARRATIVE:
The Rhode Island : Puerto Rico Asthma Center (RIPRAC) has been established to reduce disparities in asthma among Latino children. Brown University faculty involved with an extensive pediatric asthma research program will join with epidemiologists, clinicians, and health services researchers from the minority serving University of Puerto Rico to study potentially overlooked determinants of disparity. A training component (based on a successful T32 research training program) will involve individuals from both sites at both sites. The Rhode Island : Puerto Rico Asthma Center includes four projects that seek to understand the causes of disparities at multiple levels : the biomedical, the individual/family, and the socioenvironmental level. The four projects, respectively, will 1) examine discrepancies between the diagnosis of asthma as assessed by parental report, the primary care medical record and our systematic diagnosis based on the NHLBI guidelines; 2) assess characteristics (prescription practices, shared decision making, continuity and access to care) of the health care system that may differentially affect asthma morbidity; 3) evaluate family beliefs, the burden of asthma management and medication adherence as they affect asthma morbidity and health care utilization in Latino and Anglo children; and 4) study the relation of symptom perception to pediatric asthma discrepancies. Subjects for all four projects will be the same 300 mainland Anglos, 200 mainland Latinos (of Puerto Rican and Dominican descent) and 400 island Puerto Rico children with asthma, aged 7-15, thereby promoting comparability and efficiency. Chi-square analyses and ANOVA's will be used to assess differences between groups; techniques of logistic regression and multiple regression will be used to model the effects of covariates. The Center Training component will provide clinical research education and supervision to Puerto Rican trainees and faculty, enhance cultural awareness of Brown personnel as it relates to asthma disparities, and launch at least three trainee-led pilot research projects in the area.
- Conditions
- Asthma, Lung Diseases
- Medical subject headings
- Asthma, Lung Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma morbidity
Measured: 12 months retrospective and 3 months prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2006 (estimated)
- Study startSep 2002
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 983 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Glorisa Canino, Principal investigator, University of Puerto RicoGregory Fritz, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00281138
- Sponsor's protocol ID
- 1197
- Other IDs
- U01HL072438
- Status last verified
- Jul 2008
- First submitted
- 20 Jan 2006
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Asthma Disparities: Perceptions and Management
- ClinicalTrials.gov ID
- NCT00281138
- Acronym / sponsor ID
- 1197
- Conditions
- Asthma, Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 983 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2002
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 24 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To reduce disparities in asthma among Latino children.
Detailed description
BACKGROUND:
Asthma is a serious chronic condition affecting over 14 million Americans, but the prevalence rates are higher in certain populations (e.g. 10 percent in inner-cities and 30 percent among the homeless vs. 5 percent in a general population of whites). African Americans and Hispanics from the Northeast are twice as likely to die from asthma as whites. African Americans are four times as likely to be hospitalized for asthma and are five times more likely than whites to seek care for asthma at an emergency department. Reasons for these higher rates are not certain, and most likely result from an interaction of risk factors such as environmental exposures, genetic predisposition, access to appropriate medical care, socioeconomic status, and cultural health practices. The National Heart, Lung, and Blood Institute supports a variety of activities to address the pressing public health problems posed by asthma. However, progress in reducing disparities has been disappointingly slow. Separate, independent research projects have generated important clues for understanding the nature and scope of the problem. A more coordinated, interdisciplinary and comprehensive approach to research is needed to take advantage of these clues, move the science further and faster, and increase our capacity to improve health outcomes among minority and economically disadvantaged populations. Cooperative centers of research that foster partnerships among minority medical centers, research intensive institutions, and the communities in which asthma patients live will promote such advancement.
The Request for Applications for the Centers for Reducing Asthma Disparities was released in October, 2001. The objective of the program is to promote partnerships (called Centers) between a minority serving institution (MSI) that may not have a strong research program and a research intensive institution (RII) that has a track record of NIH-supported research and patient care. The purpose of the partnership is to conduct collaborative research on asthma disparities (i.e. greater prevalence of asthma, higher rates of morbidity due to asthma, and lesser access or use of quality medical care among minorities and poor).
DESIGN NARRATIVE:
The Rhode Island : Puerto Rico Asthma Center (RIPRAC) has been established to reduce disparities in asthma among Latino children. Brown University faculty involved with an extensive pediatric asthma research program will join with epidemiologists, clinicians, and health services researchers from the minority serving University of Puerto Rico to study potentially overlooked determinants of disparity. A training component (based on a successful T32 research training program) will involve individuals from both sites at both sites. The Rhode Island : Puerto Rico Asthma Center includes four projects that seek to understand the causes of disparities at multiple levels : the biomedical, the individual/family, and the socioenvironmental level. The four projects, respectively, will 1) examine discrepancies between the diagnosis of asthma as assessed by parental report, the primary care medical record and our systematic diagnosis based on the NHLBI guidelines; 2) assess characteristics (prescription practices, shared decision making, continuity and access to care) of the health care system that may differentially affect asthma morbidity; 3) evaluate family beliefs, the burden of asthma management and medication adherence as they affect asthma morbidity and health care utilization in Latino and Anglo children; and 4) study the relation of symptom perception to pediatric asthma discrepancies. Subjects for all four projects will be the same 300 mainland Anglos, 200 mainland Latinos (of Puerto Rican and Dominican descent) and 400 island Puerto Rico children with asthma, aged 7-15, thereby promoting comparability and efficiency. Chi-square analyses and ANOVA's will be used to assess differences between groups; techniques of logistic regression and multiple regression will be used to model the effects of covariates. The Center Training component will provide clinical research education and supervision to Puerto Rican trainees and faculty, enhance cultural awareness of Brown personnel as it relates to asthma disparities, and launch at least three trainee-led pilot research projects in the area.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with asthma or a history of breathing problems, from Non-Latino white, Puerto Rican or Dominican ethnicities. Participant recruitment occurred in Rhode Island and in island Puerto Rico.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Asthma morbidity
Time frame: 12 months retrospective and 3 months prospective
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Glorisa Canino principal investigator
University of Puerto Rico
Gregory Fritz principal investigator
Rhode Island Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Lung Diseases, run by Rhode Island Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Asthma morbidity (time frame: 12 months retrospective and 3 months prospective). 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 6 Nov 2013.