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A Randomized Trial to Improve Quality of Life Outcomes in Asthma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00197964
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 23, 2011
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

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.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Enhance asthma knowledge, self-efficacy, social support Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: A Randomized Trial to Improve Quality of Life Outcomes in Asthma Patients
Study Start Date : August 2001
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Primary Outcome Measures :
  1. The primary outcome is the change in the Asthma Quality of Life Questionnaire scores from enrollment to two years.

Secondary Outcome Measures :
  1. The secondary outcomes are change in Asthma Self-efficacy Scale scores and differences in urgent resource utilization between groups.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00197964

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
Principal Investigator: Carol A Mancuso, MD Hospital for Special Surgery, New York

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hospital for Special Surgery, New York Identifier: NCT00197964     History of Changes
Other Study ID Numbers: NHLBI K23 HL 04067
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: November 23, 2011
Last Verified: November 2011

Keywords provided by Hospital for Special Surgery, New York:
Quality of life
Resource utilization

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases