AsthmaNCT00005484
Predictors of Hospital-Based Care in Asthma
An observational study of Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To identify clinical predictors of episodes of hospital-based care in people with 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
- Apr 1992to Mar 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To identify clinical predictors of episodes of hospital-based care in people with asthma.
Read the detailed description
BACKGROUND:
This study was of great practical importance because asthma is a common condition (3-5 percent of the population) which has had a recent, unexplained rise in morbidity and mortality. Many previous epidemiological studies focused on predictors of hospitalization for people with asthma seen in the emergency room. These studies were of limited value for the practicing physician who sees the vast majority of patients with asthma.
Results from this study should, for the first time, enable a profile to be constructed of the high risk patient with asthma which includes identification of modifiable risk factors. These results can be used for physician and patient education programs as well as to target medical intervention.
DESIGN NARRATIVE:
The study developed a key piece of information needed for outpatient care of patients with asthma; a profile of patients at risk for severe, potentially life-threatening exacerbations of asthma. The experimental design was a prospective study of 800 patients with asthma drawn from a large, pre-paid health care plan. The key advantage of this population was that all the care occurred within the health plan. Characteristics identified included demographic factors, socioeconomic status; patient characteristics such as tobacco use, atopy, pattern of medication use, self-reporting of compliance/adherence, attitudes about asthma; historical assessment of indoor air quality; characteristics of asthma such as duration of asthma, lung function, and variation in asthma symptoms; and speciality of physician. The outcome measures were obtained over a three year period and included all episodes of hospital-based care including hospitalizations, emergency room visits, and urgency care clinic visits. Based on these data, models were developed which assigned relative risk to each of the independent variables. These models were validated in a subset of the population.
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 startApr 1992
- Study completionMar 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Investigators
- Molly Osborne, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005484
- Sponsor's protocol ID
- 5000
- Other IDs
- R29HL048237
- Status last verified
- Mar 2004
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Osborne ML, Vollmer WM, Linton KL, Buist AS. Characteristics of patients with asthma within a large HMO: a comparison by age and gender. Am J Respir Crit Care Med. 1998 Jan;157(1):123-8. doi: 10.1164/ajrccm.157.1.9612063.
PubMed 9445289Emery NL, Vollmer WM, Buist AS, Osborne ML. Self-reported food reactions and their associations with asthma. West J Nurs Res. 1996 Dec;18(6):643-54. doi: 10.1177/019394599601800603.
PubMed 9000872Sippel JM, Pedula KL, Vollmer WM, Buist AS, Osborne ML. Associations of smoking with hospital-based care and quality of life in patients with obstructive airway disease. Chest. 1999 Mar;115(3):691-6. doi: 10.1378/chest.115.3.691.
PubMed 10084477Osborne ML, Vollmer WM, Pedula KL, Wilkins J, Buist AS, O'Hollaren M. Lack of correlation of symptoms with specialist-assessed long-term asthma severity. Chest. 1999 Jan;115(1):85-91. doi: 10.1378/chest.115.1.85.
PubMed 9925066
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
- Predictors of Hospital-Based Care in Asthma
- ClinicalTrials.gov ID
- NCT00005484
- Acronym / sponsor ID
- 5000
- 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
- Apr 1992
- Study completion
- Mar 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 identify clinical predictors of episodes of hospital-based care in people with asthma.
Detailed description
BACKGROUND:
This study was of great practical importance because asthma is a common condition (3-5 percent of the population) which has had a recent, unexplained rise in morbidity and mortality. Many previous epidemiological studies focused on predictors of hospitalization for people with asthma seen in the emergency room. These studies were of limited value for the practicing physician who sees the vast majority of patients with asthma.
Results from this study should, for the first time, enable a profile to be constructed of the high risk patient with asthma which includes identification of modifiable risk factors. These results can be used for physician and patient education programs as well as to target medical intervention.
DESIGN NARRATIVE:
The study developed a key piece of information needed for outpatient care of patients with asthma; a profile of patients at risk for severe, potentially life-threatening exacerbations of asthma. The experimental design was a prospective study of 800 patients with asthma drawn from a large, pre-paid health care plan. The key advantage of this population was that all the care occurred within the health plan. Characteristics identified included demographic factors, socioeconomic status; patient characteristics such as tobacco use, atopy, pattern of medication use, self-reporting of compliance/adherence, attitudes about asthma; historical assessment of indoor air quality; characteristics of asthma such as duration of asthma, lung function, and variation in asthma symptoms; and speciality of physician. The outcome measures were obtained over a three year period and included all episodes of hospital-based care including hospitalizations, emergency room visits, and urgency care clinic visits. Based on these data, models were developed which assigned relative risk to each of the independent variables. These models were validated in a subset of the population.
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 9445289Osborne ML, Vollmer WM, Linton KL, Buist AS. Characteristics of patients with asthma within a large HMO: a comparison by age and gender. Am J Respir Crit Care Med. 1998 Jan;157(1):123-8. doi: 10.1164/ajrccm.157.1.9612063.
- Background: PubMed 9000872Emery NL, Vollmer WM, Buist AS, Osborne ML. Self-reported food reactions and their associations with asthma. West J Nurs Res. 1996 Dec;18(6):643-54. doi: 10.1177/019394599601800603.
- Background: PubMed 10084477Sippel JM, Pedula KL, Vollmer WM, Buist AS, Osborne ML. Associations of smoking with hospital-based care and quality of life in patients with obstructive airway disease. Chest. 1999 Mar;115(3):691-6. doi: 10.1378/chest.115.3.691.
- Background: PubMed 9925066Osborne ML, Vollmer WM, Pedula KL, Wilkins J, Buist AS, O'Hollaren M. Lack of correlation of symptoms with specialist-assessed long-term asthma severity. Chest. 1999 Jan;115(1):85-91. doi: 10.1378/chest.115.1.85.
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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.
Molly Osborne
Oregon Health and Science University
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 NCT00005484, which also lists 4 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.