Asthma Patient Education in the Emergency Room - Full Text View

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00110409

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

MedlinePlus related topics: Asthma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Trial of Asthma Patient Education in the Emergency Room

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

Quality of life [ Time Frame: Measured at 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator 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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110409

Locations

United States, New York
Hospital for Special Surgery	Recruiting
New York, New York, United States, 10021
Contact: Carol A. Mancuso, MD 212-774-7508 camancus@med.cornell.edu
Principal Investigator: Carol A. Mancuso, MD

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Study Chair:

Carol A. Mancuso, MD

Hospital for Special Surgery

More Information

Publications:

Mancuso CA, Peterson MG. Different methods to assess quality of life from multiple follow-ups in a longitudinal asthma study. J Clin Epidemiol. 2004 Jan;57(1):45-54.

Mancuso CA, Rincon M, Robbins L, Charlson ME. Patients' expectations of asthma treatment. J Asthma. 2003 Dec;40(8):873-81.

Mancuso CA, Rincon M, Charlson ME. Adverse work outcomes and events attributed to asthma. Am J Ind Med. 2003 Sep;44(3):236-45.

Mancuso CA, Rincon M, McCulloch CE, Charlson ME. Self-efficacy, depressive symptoms, and patients' expectations predict outcomes in asthma. Med Care. 2001 Dec;39(12):1326-38.

Mancuso CA, Peterson MG, Charlson ME. Effects of depressive symptoms on health-related quality of life in asthma patients. J Gen Intern Med. 2000 May;15(5):301-10.

Responsible Party:	Hospital for Special Surgery ( Carol A. Mancuso, MD )
Study ID Numbers:	173, R01 HL075893
Study First Received:	May 6, 2005
Last Updated:	August 29, 2008
ClinicalTrials.gov Identifier:	NCT00110409
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Emergencies
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009