Expired Study
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New York, New York


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.


Study summary:

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.


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


Study is Available At:


Original ID:

173


NCT ID:

NCT00110409


Secondary ID:

R01HL075893


Study Acronym:


Brief Title:

Asthma Patient Education in the Emergency Room


Official Title:

Trial of Asthma Patient Education in the Emergency Room


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

95 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Hospital for Special Surgery, New York


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

296


Enrollment Type:

Anticipated


Overall Contact Information

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

Study Dates

Start Date:January 2005
Completion Date:February 2010
Completion Type:Actual
Primary Completion Date:February 2010
Primary Completion Type:Actual
Verification Date:June 2013
Last Changed Date:June 7, 2013
First Received Date:May 6, 2005

Study Outcomes

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

Study Interventions

Intervention Type:Behavioral
Name:Asthma Education in Adults
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.
Arm Name:1
Intervention Type:Behavioral
Name:Standard Emergency Room Asthma Education
Description:Participants will receive standard emergency room education about asthma.
Arm Name:2

Study Arms

Study Arm Type:Experimental
Arm Name:1
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.
Study Arm Type:Active Comparator
Arm Name:2
Description:Participants in the control group will receive standard emergency room education about asthma.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Hospital for Special Surgery, New York
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Heart, Lung, and Blood Institute (NHLBI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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.
PMID:15019010
Reference Type:Reference
Citation:Mancuso CA, Rincon M, Robbins L, Charlson ME. Patients' expectations of asthma treatment. J Asthma. 2003 Dec;40(8):873-81.
PMID:14736086
Reference Type:Reference
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.
PMID:12929143
Reference Type:Reference
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.
PMID:11717574
Reference Type:Reference
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.
PMID:10840265

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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