Asthma Patient Education in the Emergency Room

NCT ID: NCT00110409

Last Updated: 2013-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

296 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2010-02-28

Brief Summary

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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

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Asthma Education in Adults

Intervention Type BEHAVIORAL

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

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

Group Type ACTIVE_COMPARATOR

Standard Emergency Room Asthma Education

Intervention Type BEHAVIORAL

Participants will receive standard emergency room education about asthma.

Interventions

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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.

Intervention Type BEHAVIORAL

Standard Emergency Room Asthma Education

Participants will receive standard emergency room education about asthma.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Hospital for Special Surgery, New York

OTHER

Sponsor Role lead

Responsible Party

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Hospital for Special Surgery

Principal Investigators

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Carol A. Mancuso, MD

Role: STUDY_CHAIR

Hospital for Special Surgery, New York

Locations

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New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15019010 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14736086 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12929143 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11717574 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10840265 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22742414 (View on PubMed)

Other Identifiers

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R01HL075893

Identifier Type: NIH

Identifier Source: secondary_id

View Link

173

Identifier Type: -

Identifier Source: org_study_id

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