New York, United States
NCT Number: NCT00110409
Asthma Patient Education in the Emergency Room
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.
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Notify MeKey information
Conditions
Age range
18 year–95 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Asthma Education in Adults
BehavioralThe 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.
Standard Emergency Room Asthma Education
BehavioralParticipants will receive standard emergency room education about asthma.
Primary outcomes
-
Quality of life
Time frame: Measured at 8 weeks
Secondary outcomes
-
Rescue inhaled beta agonist use
Time frame: Measured at 8 weeks
-
Peak flow meter rates
Time frame: Measured at 8 weeks
-
Number of days lost from work or school due to asthma
Time frame: Measured at 8 weeks
-
Decreasing urgent resource utilization for asthma
Time frame: Measured at 16 weeks and 1 year
-
Cost effectiveness
Time frame: Measured at 16 weeks and 1 year
Sponsors and collaborators
Lead sponsor
Hospital for Special Surgery, New York
Other
Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
Registry information
Official study title
Trial of Asthma Patient Education in the Emergency Room
Important dates
- Study start
- 2005
- Primary completion
- 2010
- Study completion
- 2010
- First posted
- May 9, 2005
- Registry last updated
- Jun 10, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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