NCT00197964

Brief Summary

Among 180 patients with moderate asthma, the specific aim of this randomized trial is to assess the effectiveness of an intervention involving education, enhancement of self-efficacy, and asthma social support in preventing deterioration in functional status over two years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Aug 2001

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

August 1, 2001

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

November 23, 2011

Status Verified

November 1, 2011

Enrollment Period

3.7 years

First QC Date

September 12, 2005

Last Update Submit

November 22, 2011

Conditions

Asthma

Keywords

Self-managementSelf-efficacyQuality of lifeResource utilization

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is the change in the Asthma Quality of Life Questionnaire scores from enrollment to two years.

Secondary Outcomes (1)

  • The secondary outcomes are change in Asthma Self-efficacy Scale scores and differences in urgent resource utilization between groups.

Interventions

Enhance asthma knowledge, self-efficacy, social supportBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • Patients will be eligible for this study if they are 18 years of age or older and have moderate asthma based on the NHLBI Asthma Expert Panel's classification which rates symptoms, frequency of exacerbations, nocturnal attacks, activity restriction, use of medications, and pulmonary function.

You may not qualify if:

  • Patients will be excluded from this study for the following reasons: if they are have other pulmonary diseases; if they are unable to provide informed consent because of cognitive deficits; if they are not fluent in English; if they refuse to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Presbyterian Hospital - Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Related Publications (9)

  • 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

  • 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, Sayles W, Allegrante JP. Randomized trial of self-management education in asthmatic patients and effects of depressive symptoms. Ann Allergy Asthma Immunol. 2010 Jul;105(1):12-9. doi: 10.1016/j.anai.2010.04.009.

    PMID: 20642198RESULT

  • Mancuso CA, Sayles W, Allegrante JP. Knowledge, attitude, and self-efficacy in asthma self-management and quality of life. J Asthma. 2010 Oct;47(8):883-8. doi: 10.3109/02770903.2010.492540.

    PMID: 20831465RESULT

  • Mancuso CA, Sayles W, Allegrante JP. Development and testing of the Asthma Self-Management Questionnaire. Ann Allergy Asthma Immunol. 2009 Apr;102(4):294-302. doi: 10.1016/S1081-1206(10)60334-1.

    PMID: 19441600DERIVED

  • Choi TN, Westermann H, Sayles W, Mancuso CA, Charlson ME. Beliefs about asthma medications: patients perceive both benefits and drawbacks. J Asthma. 2008 Jun;45(5):409-14. doi: 10.1080/02770900801971834.

    PMID: 18569235DERIVED

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

August 1, 2001

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

November 23, 2011

Record last verified: 2011-11

Locations

US(1)