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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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.

  1. First posted26 May 2000 (estimated)
  2. Study startAug 1990
  3. Study completionJul 1995

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
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 8194287
  • Huss 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 8109808
  • Eggleston 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 9480996
  • Schneider 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 9335839
  • Butz 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

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.

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