AsthmaNCT00005713
Childhood Asthma Program in NYC Health Department Clinics
An observational study of Asthma and Lung Diseases, run by Columbia University at 1 site in United States.
Trial summary
To demonstrate that the New York City Department of Health Child Health Clinics could improve the health status of Black and Hispanic children with asthma by providing them with a comprehensive system of continuity of care that included pharmacologic treatment, family health education and community outreach. Read more about this study
- Who is it for?
- Ages 1 month to 21 years
- Conditions the study is for
- Asthma, Lung Diseases
- What is being tested?
- Continuing, preventative care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1990to Feb 1997
- 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 1 month to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with asthma in New York City
Who may be able to join
- Diagnosed with asthma
- Attending pediatric clinics serving low-income children in New York City
Who cannot join
- 1. Unable to return to clinics for follow up and treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Care for Minority Children With Asthma: Professional Education in Public Health Clinics
To demonstrate that the New York City Department of Health Child Health Clinics could improve the health status of Black and Hispanic children with asthma by providing them with a comprehensive system of continuity of care that included pharmacologic treatment, family health education and community outreach.
Recent studies have shown that lack of continuing primary care for asthma is associated with increased levels of morbidity in low-income minority children. Although effective preventive therapy is available, many African-American and Latino children receive episodic treatment for asthma that does not follow current guidelines for care. To see if access, continuity, and quality of care could be improved in pediatric clinics serving low-income children in New York City, we trained staff in New York City Bureau of Child Health clinics to provide continuing, preventive care for asthma.
Read the detailed description
BACKGROUND:
The study was part of a demonstration and education initiative "Interventions for Control of Asthma Among Black and Hispanic Children" which was released by the NHLBI in June 1989.
DESIGN NARRATIVE:
To develop this comprehensive care system, the investigators provided training for Health Department physicians and nurses in up-to-date methods of diagnosing asthma, and providing clinical care and health education to patients and families as part of a series of regular 20 minute patient visits. Nurses and public health assistants were also trained to supplement this by teaching the Open Airways self-management program to groups of families. A 24-hour telephone advice service for families of asthma patients was staffed by trained Health Department physicians.
The intervention was based on social cognitive theory, especially self-regulation. In Phase I, the Health Department medical and nursing staffs were taught by Columbia University faculty with reinforcement by Health Department physician and nurse supervisors. Self-regulation was fostered in physicians by use of an Asthma Visit Record and in families by use of an Asthma Diary. Seven pairs of matched clinics were randomized to be controls or receive the intervention. The following hypotheses were tested: that a comprehensive system of continuity of care, including medical care, family health education and community outreach would (1) increase staff confidence to diagnose and treat childhood asthma; (2) attract and retain families who had children with asthma in continuing care relationships in the Health Department clinics; and (3) improve the health status of patients and the quality of life of their families. Phase II tested whether this comprehensive system could be made self-sustaining within the Health Department by having physician and nurse super-visors who took part in Phase I teach the program to staff from a second set of matched clinics. This program had the potential to reach more than 5000 minority children with asthma. If successful it could be generalized to other health departments in the country.
- Conditions
- Asthma, Lung Diseases
- Being tested
- Continuing, preventative care
- Medical subject headings
- Asthma, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuing, preventative careBehavioural
Training for intervention clinic staff was based on National Asthma Education and Prevention Program guidelines for the diagnosis and management of asthma, and included screening to identify new cases and health education to improve family management.
| Study group | Role | What they receive |
|---|---|---|
| Continuing, preventative care for asthma | Low-income children with asthma will receive continuing, preventive care for asthma with trained staff in New York City Bureau of Child Health clinics Receives: Behavioral: Continuing, preventative care |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startAug 1990
- Primary completionFeb 1997
- Study completionFeb 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- David Evans, MD, Principal investigator, Professor of Emeritus of Clinical Sociomedical Sciences In Pedi, Dept of Sociomedical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005713
- Sponsor's protocol ID
- CUMC ID unknown (4922)
- Other IDs
- R01HL045304
- Status last verified
- Dec 2015
- First submitted
- 25 May 2000
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Evans D, Mellins R, Lobach K, Ramos-Bonoan C, Pinkett-Heller M, Wiesemann S, Klein I, Donahue C, Burke D, Levison M, Levin B, Zimmerman B, Clark N. Improving care for minority children with asthma: professional education in public health clinics. Pediatrics. 1997 Feb;99(2):157-64. doi: 10.1542/peds.99.2.157.
PubMed 9024439
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care for Minority Children With Asthma: Professional Education in Public Health Clinics
- ClinicalTrials.gov ID
- NCT00005713
- Acronym / sponsor ID
- CUMC ID unknown (4922)
- Conditions
- Asthma, Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 1990
- Primary completion
- Feb 1997 (actual)
- Study completion
- Feb 1997 (actual)
- First posted
- 26 May 2000 (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 demonstrate that the New York City Department of Health Child Health Clinics could improve the health status of Black and Hispanic children with asthma by providing them with a comprehensive system of continuity of care that included pharmacologic treatment, family health education and community outreach.
Recent studies have shown that lack of continuing primary care for asthma is associated with increased levels of morbidity in low-income minority children. Although effective preventive therapy is available, many African-American and Latino children receive episodic treatment for asthma that does not follow current guidelines for care. To see if access, continuity, and quality of care could be improved in pediatric clinics serving low-income children in New York City, we trained staff in New York City Bureau of Child Health clinics to provide continuing, preventive care for asthma.
Detailed description
BACKGROUND:
The study was part of a demonstration and education initiative "Interventions for Control of Asthma Among Black and Hispanic Children" which was released by the NHLBI in June 1989.
DESIGN NARRATIVE:
To develop this comprehensive care system, the investigators provided training for Health Department physicians and nurses in up-to-date methods of diagnosing asthma, and providing clinical care and health education to patients and families as part of a series of regular 20 minute patient visits. Nurses and public health assistants were also trained to supplement this by teaching the Open Airways self-management program to groups of families. A 24-hour telephone advice service for families of asthma patients was staffed by trained Health Department physicians.
The intervention was based on social cognitive theory, especially self-regulation. In Phase I, the Health Department medical and nursing staffs were taught by Columbia University faculty with reinforcement by Health Department physician and nurse supervisors. Self-regulation was fostered in physicians by use of an Asthma Visit Record and in families by use of an Asthma Diary. Seven pairs of matched clinics were randomized to be controls or receive the intervention. The following hypotheses were tested: that a comprehensive system of continuity of care, including medical care, family health education and community outreach would (1) increase staff confidence to diagnose and treat childhood asthma; (2) attract and retain families who had children with asthma in continuing care relationships in the Health Department clinics; and (3) improve the health status of patients and the quality of life of their families. Phase II tested whether this comprehensive system could be made self-sustaining within the Health Department by having physician and nurse super-visors who took part in Phase I teach the program to staff from a second set of matched clinics. This program had the potential to reach more than 5000 minority children with asthma. If successful it could be generalized to other health departments in the country.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuing, preventative care for asthma | – | Behavioral: Continuing, preventative careLow-income children with asthma will receive continuing, preventive care for asthma with trained staff in New York City Bureau of Child Health clinics |
Who may qualify
- Ages
- 1 month to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with asthma in New York City
Key inclusion criteria (2 listed)
- Diagnosed with asthma
- Attending pediatric clinics serving low-income children in New York City
Key exclusion criteria (1 listed)
- 1. Unable to return to clinics for follow up and treatment
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 |
|---|---|---|
| Continuing, preventative careTraining for intervention clinic staff was based on National Asthma Education and Prevention Program guidelines for the diagnosis and management of asthma, and included screening to identify new cases and health education to improve family management. | Behavioural | Continuing, preventative care for asthma |
Primary outcome
Not reported in the source record.
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 23 Dec 2015.
- Background: PubMed 9024439Evans D, Mellins R, Lobach K, Ramos-Bonoan C, Pinkett-Heller M, Wiesemann S, Klein I, Donahue C, Burke D, Levison M, Levin B, Zimmerman B, Clark N. Improving care for minority children with asthma: professional education in public health clinics. Pediatrics. 1997 Feb;99(2):157-64. doi: 10.1542/peds.99.2.157.
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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.
David Evans, MD principal investigator
Professor of Emeritus of Clinical Sociomedical Sciences In Pedi, Dept of Sociomedical Sciences
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 Asthma and Lung Diseases, run by Columbia 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 2 inclusion and 1 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 23 Dec 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005713, which also lists 1 linked publication.
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 23 Dec 2015.