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Asthma Patient Education in the Emergency Room

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Asthma Education in Adults
Standard Emergency Room Asthma Education
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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.

Participants in the control group will receive standard emergency room education about asthma.

Outcomes

Primary Outcome Measures

Quality of life

Secondary Outcome Measures

Rescue inhaled beta agonist use
Peak flow meter rates
Number of days lost from work or school due to asthma
Decreasing urgent resource utilization for asthma
Cost effectiveness

Full Information

First Posted
May 6, 2005
Last Updated
June 7, 2013
Sponsor
Hospital for Special Surgery, New York
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00110409
Brief Title
Asthma Patient Education in the Emergency Room
Official Title
Trial of Asthma Patient Education in the Emergency Room
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital for Special Surgery, New York
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
296 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants in the control group will receive standard emergency room education about asthma.
Intervention Type
Behavioral
Intervention Name(s)
Asthma Education in Adults
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Emergency Room Asthma Education
Intervention Description
Participants will receive standard emergency room education about asthma.
Primary Outcome Measure Information:
Title
Quality of life
Time Frame
Measured at 8 weeks
Secondary Outcome Measure Information:
Title
Rescue inhaled beta agonist use
Time Frame
Measured at 8 weeks
Title
Peak flow meter rates
Time Frame
Measured at 8 weeks
Title
Number of days lost from work or school due to asthma
Time Frame
Measured at 8 weeks
Title
Decreasing urgent resource utilization for asthma
Time Frame
Measured at 16 weeks and 1 year
Title
Cost effectiveness
Time Frame
Measured at 16 weeks and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol A. Mancuso, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Study Chair
Facility Information:
City
New York
State/Province
New York
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15019010
Citation
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. doi: 10.1016/S0895-4356(03)00248-8.
Results Reference
background
PubMed Identifier
14736086
Citation
Mancuso CA, Rincon M, Robbins L, Charlson ME. Patients' expectations of asthma treatment. J Asthma. 2003 Dec;40(8):873-81. doi: 10.1081/jas-120023578.
Results Reference
background
PubMed Identifier
12929143
Citation
Mancuso CA, Rincon M, Charlson ME. Adverse work outcomes and events attributed to asthma. Am J Ind Med. 2003 Sep;44(3):236-45. doi: 10.1002/ajim.10257.
Results Reference
background
PubMed Identifier
11717574
Citation
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. doi: 10.1097/00005650-200112000-00008.
Results Reference
background
PubMed Identifier
10840265
Citation
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. doi: 10.1046/j.1525-1497.2000.07006.x.
Results Reference
background
PubMed Identifier
22742414
Citation
Peterson MG, Gaeta TJ, Birkhahn RH, Fernandez JL, Mancuso CA. History of symptom triggers in patients presenting to the emergency department for asthma. J Asthma. 2012 Aug;49(6):629-36. doi: 10.3109/02770903.2012.690480. Epub 2012 Jun 28.
Results Reference
derived

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Asthma Patient Education in the Emergency Room

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