AsthmaNCT00005712
Self Management Education Asthma
An observational study of Asthma and Lung Diseases, run by University of New Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 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 1996
- 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 0 to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
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.
Read the 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.
- 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 1996
Why it stopped: Not a clinical trial and was inadvertently entered in the system.
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.
- 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
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005712
- Sponsor's protocol ID
- 4921
- Other IDs
- R01HL045279
- Status last verified
- Mar 2024
- First submitted
- 25 May 2000
- Last updated
- 12 Mar 2024
- Results posted
- No
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. doi: 10.1164/ajrccm.151.5.7735623.
PubMed 7735623
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Management Education Asthma
- ClinicalTrials.gov ID
- NCT00005712
- Acronym / sponsor ID
- 4921
- Conditions
- Asthma, Lung Diseases
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not a clinical trial and was inadvertently entered in the system.
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 1990
- Study completion
- Jul 1996
- 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 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 design
Who may qualify
- Ages
- 0 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 was stopped early (reason given: Not a clinical trial and was inadvertently entered in the system.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 7735623Clark 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. doi: 10.1164/ajrccm.151.5.7735623.
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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 University of New Mexico.
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: stopped early, as of the sponsor's last update on 12 Mar 2024. 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 was stopped early (reason given: Not a clinical trial and was inadvertently entered in the system.). Results are not available in the source record.
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 NCT00005712, 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 12 Mar 2024.