AsthmaNCT00005715
Community Intervention for Minority Children With Asthma
An observational study of Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To test the effectiveness of school-based asthma education interventions, community-based asthma health workers' programs and the combination of these on asthmatic children. Also, to examine the separate and combined impact of asthma interventions designed to address problems associated with effective asthma… Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Asthma, Lung Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 1990to Jul 1995
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To test the effectiveness of school-based asthma education interventions, community-based asthma health workers' programs and the combination of these on asthmatic children. Also, to examine the separate and combined impact of asthma interventions designed to address problems associated with effective asthma self-management amd difficulties in establishing and maintaining continuity of medical care.
Read the detailed description
BACKGROUND:
Asthma is a leading cause of childhood illness that disproportionately affects minority children. The causes of higher hospitalization and death rates among minority children with asthma are not understood. It is commonly assumed that barriers related to poverty underlie this public health issue. Two proposed causes of this increased morbidity and mortality are problems associated with effective asthma self-management and difficulties in establishing and maintaining continuity of medical care.
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:
A school-based asthma self-management program was developed to promote children's self-management skills within predominately minority schools. A community-based asthma health worker program was developed to assist minority families in establishing and maintaining asthma health care within the community. It was hypothesized that the most effective control of asthma would be achieved with the combination of these two interventions. Twenty elementary schools each in inner-city Baltimore, Maryland and inner-city Washington D.C. served as study sites. Asthmatic children grades 1-5 were identified by school records and parent surveys. After obtaining consent, schools were randomly assigned to one of four intervention groups: 1) a control/minimal intervention, 2) a school-based asthma education program, 3) a community-based asthma health worker program, and 4) a combined intervention that included both the school-based education program and the community-based health worker program. The duration of both the school program and the Community health worker program was twelve months. Baseline measures were collected after obtaining consent and prior to school randomization. Followup measures were collected from children and families at 6, 12, 18, and 24 months. Data were collected on hospitalization, emergency or urgent care, acute episodes, health care utilization, medications, school absences, academic performance, self-esteem, self and family asthma management, and family coping.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Asthma, Lung Diseases
- Medical subject headings
- Asthma, Lung Diseases
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
- Study completionJul 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005715
- Sponsor's protocol ID
- 4924
- Other IDs
- R01HL045312
- Status last verified
- May 2000
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Butz AM, Malveaux FJ, Eggleston P, Thompson L, Schneider S, Weeks K, Huss K, Murigande C, Rand CS. Use of community health workers with inner-city children who have asthma. Clin Pediatr (Phila). 1994 Mar;33(3):135-41. doi: 10.1177/000992289403300302.
PubMed 8194287Huss K, Rand CS, Butz AM, Eggleston PA, Murigande C, Thompson LC, Schneider S, Weeks K, Malveaux FJ. Home environmental risk factors in urban minority asthmatic children. Ann Allergy. 1994 Feb;72(2):173-7.
PubMed 8109808Eggleston PA, Malveaux FJ, Butz AM, Huss K, Thompson L, Kolodner K, Rand CS. Medications used by children with asthma living in the inner city. Pediatrics. 1998 Mar;101(3 Pt 1):349-54. doi: 10.1542/peds.101.3.349.
PubMed 9480996Schneider SL, Richard M, Huss K, Huss RW, Thompson LC, Butz AM, Eggleston PA, Kolodner KB, Rand CS, Malveaux FJ. Moving health care education into the community. Nurs Manage. 1997 Sep;28(9):40-3.
PubMed 9335839Butz AM, Malveaux FJ, Eggleston P, Thompson L, Huss K, Kolodner K, Rand CS. Social factors associated with behavioral problems in children with asthma. Clin Pediatr (Phila). 1995 Nov;34(11):581-90. doi: 10.1177/000992289503401103.
PubMed 8565388
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Intervention for Minority Children With Asthma
- ClinicalTrials.gov ID
- NCT00005715
- Acronym / sponsor ID
- 4924
- Conditions
- Asthma, Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Aug 1990
- Study completion
- Jul 1995 (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 test the effectiveness of school-based asthma education interventions, community-based asthma health workers' programs and the combination of these on asthmatic children. Also, to examine the separate and combined impact of asthma interventions designed to address problems associated with effective asthma self-management amd difficulties in establishing and maintaining continuity of medical care.
Detailed description
BACKGROUND:
Asthma is a leading cause of childhood illness that disproportionately affects minority children. The causes of higher hospitalization and death rates among minority children with asthma are not understood. It is commonly assumed that barriers related to poverty underlie this public health issue. Two proposed causes of this increased morbidity and mortality are problems associated with effective asthma self-management and difficulties in establishing and maintaining continuity of medical care.
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:
A school-based asthma self-management program was developed to promote children's self-management skills within predominately minority schools. A community-based asthma health worker program was developed to assist minority families in establishing and maintaining asthma health care within the community. It was hypothesized that the most effective control of asthma would be achieved with the combination of these two interventions. Twenty elementary schools each in inner-city Baltimore, Maryland and inner-city Washington D.C. served as study sites. Asthmatic children grades 1-5 were identified by school records and parent surveys. After obtaining consent, schools were randomly assigned to one of four intervention groups: 1) a control/minimal intervention, 2) a school-based asthma education program, 3) a community-based asthma health worker program, and 4) a combined intervention that included both the school-based education program and the community-based health worker program. The duration of both the school program and the Community health worker program was twelve months. Baseline measures were collected after obtaining consent and prior to school randomization. Followup measures were collected from children and families at 6, 12, 18, and 24 months. Data were collected on hospitalization, emergency or urgent care, acute episodes, health care utilization, medications, school absences, academic performance, self-esteem, self and family asthma management, and family coping.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
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 18 Feb 2016.
- Background: PubMed 8194287Butz AM, Malveaux FJ, Eggleston P, Thompson L, Schneider S, Weeks K, Huss K, Murigande C, Rand CS. Use of community health workers with inner-city children who have asthma. Clin Pediatr (Phila). 1994 Mar;33(3):135-41. doi: 10.1177/000992289403300302.
- Background: PubMed 8109808Huss K, Rand CS, Butz AM, Eggleston PA, Murigande C, Thompson LC, Schneider S, Weeks K, Malveaux FJ. Home environmental risk factors in urban minority asthmatic children. Ann Allergy. 1994 Feb;72(2):173-7.
- Background: PubMed 9480996Eggleston PA, Malveaux FJ, Butz AM, Huss K, Thompson L, Kolodner K, Rand CS. Medications used by children with asthma living in the inner city. Pediatrics. 1998 Mar;101(3 Pt 1):349-54. doi: 10.1542/peds.101.3.349.
- Background: PubMed 9335839Schneider SL, Richard M, Huss K, Huss RW, Thompson LC, Butz AM, Eggleston PA, Kolodner KB, Rand CS, Malveaux FJ. Moving health care education into the community. Nurs Manage. 1997 Sep;28(9):40-3.
- Background: PubMed 8565388Butz AM, Malveaux FJ, Eggleston P, Thompson L, Huss K, Kolodner K, Rand CS. Social factors associated with behavioral problems in children with asthma. Clin Pediatr (Phila). 1995 Nov;34(11):581-90. doi: 10.1177/000992289503401103.
Related trials for Asthma
Active, not recruitingPhase 1
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
Asthma
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice
Asthma
RecruitingPhase 3
A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)
Asthma
Not yet recruitingPhase 4
Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
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 18 Feb 2016. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005715, which also lists 5 linked publications.
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 18 Feb 2016.