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Completed

NCT Number: NCT00197964

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Presbyterian Hospital - Weill Medical College of Cornell University

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enhance asthma knowledge, self-efficacy, social support

Behavioral

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.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Important dates

Study start
2001
Primary completion
2005
Study completion
2005
First posted
Sep 20, 2005
Registry last updated
Nov 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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