Asthma Patient Education in the Emergency Room

June 7, 2013 updated by: Hospital for Special Surgery, New York

Trial of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

296

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: Measured at 8 weeks
Measured at 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Rescue inhaled beta agonist use
Time Frame: Measured at 8 weeks
Measured at 8 weeks
Peak flow meter rates
Time Frame: Measured at 8 weeks
Measured at 8 weeks
Number of days lost from work or school due to asthma
Time Frame: Measured at 8 weeks
Measured at 8 weeks
Decreasing urgent resource utilization for asthma
Time Frame: Measured at 16 weeks and 1 year
Measured at 16 weeks and 1 year
Cost effectiveness
Time Frame: Measured at 16 weeks and 1 year
Measured at 16 weeks and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Study Chair: Carol A. Mancuso, MD, Hospital for Special Surgery, New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

May 6, 2005

First Submitted That Met QC Criteria

May 6, 2005

First Posted (Estimate)

May 9, 2005

Study Record Updates

Last Update Posted (Estimate)

June 10, 2013

Last Update Submitted That Met QC Criteria

June 7, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 173
  • R01HL075893 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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