Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Asthma Patient Education in the Emergency Room

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT00110409
First received: May 6, 2005
Last updated: June 7, 2013
Last verified: June 2013
  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

Further study details as provided by Hospital for Special Surgery, New York:

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
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
New York, New York, United States
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Study Chair: Carol A. Mancuso, MD Hospital for Special Surgery, New York
  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, R01HL075893, R01 HL075893
Study First Received: May 6, 2005
Last Updated: June 7, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014