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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197964
• Other study ID #: NHLBI K23 HL 04067
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: November 22, 2011
• Start date: August 2001
• Est. completion date: April 2005

Study information

• Verified date: November 2011
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Enhance asthma knowledge, self-efficacy, social support

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital - Weill Medical College of Cornell University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. doi: 10.3109/02770903.2010.492540. — View Citation

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. doi: 10.1016/j.anai.2010.04.009. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the change in the Asthma Quality of Life Questionnaire scores from enrollment to two years.			No
Secondary	The secondary outcomes are change in Asthma Self-efficacy Scale scores and differences in urgent resource utilization between groups.			No