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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT00197964
First received: September 12, 2005
Last updated: November 22, 2011
Last verified: November 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 21, 2014