A Randomized Trial to Improve Quality of Life Outcomes in Asthma Patients - Full Text View

Purpose

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.

Condition	Intervention
Asthma	Behavioral: Enhance asthma knowledge, self-efficacy, social support

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Health Services Research
Official Title:	A Randomized Trial to Improve Quality of Life Outcomes in Asthma Patients

Resource links provided by NLM:

MedlinePlus related topics: Asthma

U.S. FDA Resources

Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:

The primary outcome is the change in the Asthma Quality of Life Questionnaire scores from enrollment to two years. [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary outcomes are change in Asthma Self-efficacy Scale scores and differences in urgent resource utilization between groups. [ Designated as safety issue: No ]

Enrollment:	180
Study Start Date:	August 2001
Study Completion Date:	April 2005
Primary Completion Date:	April 2005 (Final data collection date for primary outcome measure)

Detailed Description:

The goals of this study are to develop and implement a multi-component intervention to improve quality of life and decrease urgent resource utilization in adult asthma patients followed in a primary care practice. Specifically, the intervention involves a two-component self-directed self-management workbook. The first component focuses on increasing knowledge by providing patients with factual information about asthma and self-management. The second component focuses on asthma self-efficacy using case vignettes and making a contract to adopt a behavior to improve asthma. Asthma-related social support is achieved through interval telephone contact.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197964

Locations

United States, New York
New York Presbyterian Hospital - Weill Medical College of Cornell University
New York, New York, United States, 10021

Sponsors and Collaborators

Hospital for Special Surgery, New York

Investigators

Principal Investigator:

Carol A Mancuso, MD

Hospital for Special Surgery, New York

More Information

Publications:

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.

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.

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.

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.

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.

Mancuso CA, Rincon M, Robbins L, Charlson ME. Patients' expectations of asthma treatment. J Asthma. 2003 Dec;40(8):873-81.

Mancuso CA, Rincon M, Charlson ME. Adverse work outcomes and events attributed to asthma. Am J Ind Med. 2003 Sep;44(3):236-45.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

Responsible Party:	Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:	NCT00197964 History of Changes
Other Study ID Numbers:	NHLBI K23 HL 04067
Study First Received:	September 12, 2005
Last Updated:	November 22, 2011
Health Authority:	United States: Federal Government

Keywords provided by Hospital for Special Surgery, New York:

Self-management
Self-efficacy
Quality of life
Resource utilization

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013