Asthma Patient Education in the Emergency Room
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Purpose
The objective of this randomized trial is to assess the effectiveness of an intervention involving education, self-efficacy, and social support in improving quality of life outcomes among 296 adult asthma patients treated in the emergency room. The main outcome will be a comparison of within-patient change in quality of life between enrollment and 8 weeks. Secondary objectives will be to assess the effectiveness of the intervention in decreasing the need for rescue inhaled beta agonists, in improving peak flow meter rates, and in decreasing the number of days lost from work or school due to asthma. These outcomes will be measured again at 16 weeks to determine if benefits are sustained. Additional outcomes at 16 weeks and 1 year will be to assess the effectiveness of the intervention in decreasing urgent resource utilization for asthma and cost effectiveness.
| Condition | Intervention |
|---|---|
|
Asthma |
Behavioral: Asthma Education in Adults Behavioral: Standard Emergency Room Asthma Education |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Trial of Asthma Patient Education in the Emergency Room |
- Quality of life [ Time Frame: Measured at 8 weeks ] [ Designated as safety issue: No ]
- Rescue inhaled beta agonist use [ Time Frame: Measured at 8 weeks ] [ Designated as safety issue: No ]
- Peak flow meter rates [ Time Frame: Measured at 8 weeks ] [ Designated as safety issue: No ]
- Number of days lost from work or school due to asthma [ Time Frame: Measured at 8 weeks ] [ Designated as safety issue: No ]
- Decreasing urgent resource utilization for asthma [ Time Frame: Measured at 16 weeks and 1 year ] [ Designated as safety issue: No ]
- Cost effectiveness [ Time Frame: Measured at 16 weeks and 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 296 |
| Study Start Date: | January 2005 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Intervention participants will receive information focusing on asthma self-management, education, self-efficacy, and social support while in the hospital emergency room. Telephone reinforcement will occur for 8 weeks following study entry.
|
Behavioral: Asthma Education in Adults
The intervention involves enhancing asthma education, asthma self-efficacy and asthma-related social support and is administered during a single in-person session in the ED (or hospital for admitted patients) followed by telephone reinforcement.
|
|
Active Comparator: 2
Participants in the control group will receive standard emergency room education about asthma.
|
Behavioral: Standard Emergency Room Asthma Education
Participants will receive standard emergency room education about asthma.
|
Detailed Description:
BACKGROUND:
Many urban asthma emergency room patients lack effective self-management. Most current training programs are administered in outpatient settings and have low attendance rates for emergency room patients. There is a great need to develop effective programs that can be easily administered in the emergency room for patients who, in many cases, are not present in other settings to receive education. This proposal builds on preliminary studies and is tailored to provide emergency room patients with basic education during "a teachable moment" when they may be most receptive to asthma information.
DESIGN NARRATIVE:
Patients will be recruited from two New York City urban emergency rooms or inpatient settings and randomized to the intervention or control groups. Intervention patients will receive a protocol focusing on asthma self-management, education, self-efficacy, and social support, with telephone reinforcement for 8 weeks. Control patients will receive standard emergency room education about asthma.
Eligibility| Ages Eligible for Study: | 18 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients will be eligible if they are 18 years of age or older
- Fluent in English
- Have a known diagnosis of asthma
- Will receive treatment for asthma during the current hospitalization or emergency room visit.
Exclusion Criteria:
- Cognitive deficits
- Other pulmonary diseases or severe comorbidity
- Do not have out-patient access to a telephone
Contacts and Locations
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Carol A. Mancuso, MD, Hospital for Special Surgery |
| ClinicalTrials.gov Identifier: | NCT00110409 History of Changes |
| Other Study ID Numbers: | 173, R01 HL075893 |
| Study First Received: | May 6, 2005 |
| Last Updated: | July 6, 2011 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Asthma Emergencies Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013