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

Not Applicable

Completed

• Conditions: Asthma

• Registration Number: NCT00197964
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2001-08
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-22
• Last Update Posted: 2011-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

New York Presbyterian Hospital - Weill Medical College of Cornell University; 🇺🇸 New York, New York, United States