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| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 25, 2000 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | August 1990 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00005712 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Self Management Education Asthma |
| Official Title ICMJE | |
| Brief Summary | To evaluate the effects of a new statewide program to enhance identification, referral and provision of care to rural families of Hispanic children with moderately severe to severe asthma. Specifically, to determine if comprehensive medical care (CMC) plus an educational self-management program for rural Hispanic children and their families had an impact on asthma morbidity, as well as on cost and family adaptation. |
| Detailed Description | BACKGROUND: Because of New Mexico's large rural and heavily Hispanic population, it was an ideal setting to determine effective methods for case management, self-management educational programs and effective tertiary to primary care delivery collaboration. 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 randomized block design was used with random assignment of subjects by county to treatment groups of 1. comprehensive medical care or standard tertiary care and education, or 2. CMC-Plus adding a structured self-management program--Open Airways/Respiro Abierto (developed and tested with support of NHLBI). CMC-Plus also received in home education and intervention from community based Hispanic family educators trained in an empowerment model of family intervention, in-home support, and education. Case management was provided by CMS; CMC and CMC-Plus were provided at the UNM-PPP in close collaboration with and transfer of care to the primary physician. Additional educational contact with primary care providers and emergency rooms were provided through the UNM Department of Family, Community & Emergency Medicine which utilized the National Institutes of Health National Asthma Education Program's Guidelines for Step-Wise Care of Asthma. Asthma morbidity, cost of care, family adaptation and family satisfaction were evaluated using standardized instruments. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Natural History |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * | Clark D, Gollub R, Green WF, Harvey N, Murphy SJ, Samet JM. Asthma in Jemez Pueblo schoolchildren. Am J Respir Crit Care Med. 1995 May;151(5):1625-7. |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | July 1996 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | No eligibility criteria |
| Gender | Male |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | |
| Administrative Information | |
| NCT ID ICMJE | NCT00005712 |
| Responsible Party | |
| Study ID Numbers ICMJE | 4921 |
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) |
| Verification Date | May 2002 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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