NCT00110409

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
296

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2005

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

June 10, 2013

Status Verified

June 1, 2013

Enrollment Period

5.1 years

First QC Date

May 6, 2005

Last Update Submit

June 7, 2013

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    Measured at 8 weeks

Secondary Outcomes (5)

  • Rescue inhaled beta agonist use

    Measured at 8 weeks

  • Peak flow meter rates

    Measured at 8 weeks

  • Number of days lost from work or school due to asthma

    Measured at 8 weeks

  • Decreasing urgent resource utilization for asthma

    Measured at 16 weeks and 1 year

  • Cost effectiveness

    Measured at 16 weeks and 1 year

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

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

Behavioral: Standard Emergency Room Asthma Education

Interventions

Asthma Education in AdultsBEHAVIORAL

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.

1
Standard Emergency Room Asthma EducationBEHAVIORAL

Participants will receive standard emergency room education about asthma.

2

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Cognitive deficits
  • Other pulmonary diseases or severe comorbidity
  • Do not have out-patient access to a telephone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

New York, New York, United States

Location

Related Publications (6)

  • 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.

    PMID: 15019010BACKGROUND

  • 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.

    PMID: 14736086BACKGROUND

  • 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.

    PMID: 12929143BACKGROUND

  • 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.

    PMID: 11717574BACKGROUND

  • 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.

    PMID: 10840265BACKGROUND

  • 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.

    PMID: 22742414DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Carol A. Mancuso, MD

    Hospital for Special Surgery, New York

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2005

First Posted

May 9, 2005

Study Start

January 1, 2005

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

June 10, 2013

Record last verified: 2013-06

Locations

US(1)