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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhance asthma knowledge, self-efficacy, social support
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring Self-management, Self-efficacy, Quality of life, Resource utilization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York Presbyterian Hospital - Weill Medical College of Cornell University

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
November 22, 2011
Sponsor
Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT00197964
Brief Title
A Randomized Trial to Improve Quality of Life Outcomes in Asthma Patients
Official Title
A Randomized Trial to Improve Quality of Life Outcomes in Asthma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Self-management, Self-efficacy, Quality of life, Resource utilization

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Enhance asthma knowledge, self-efficacy, social support
Primary Outcome Measure Information:
Title
The primary outcome is the change in the Asthma Quality of Life Questionnaire scores from enrollment to two years.
Secondary Outcome Measure Information:
Title
The secondary outcomes are change in Asthma Self-efficacy Scale scores and differences in urgent resource utilization between groups.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol A Mancuso, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Presbyterian Hospital - Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11717574
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. doi: 10.1097/00005650-200112000-00008.
Results Reference
background
PubMed Identifier
10840265
Citation
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. doi: 10.1046/j.1525-1497.2000.07006.x.
Results Reference
background
PubMed Identifier
15019010
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. doi: 10.1016/S0895-4356(03)00248-8.
Results Reference
background
PubMed Identifier
14736086
Citation
Mancuso CA, Rincon M, Robbins L, Charlson ME. Patients' expectations of asthma treatment. J Asthma. 2003 Dec;40(8):873-81. doi: 10.1081/jas-120023578.
Results Reference
background
PubMed Identifier
12929143
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. doi: 10.1002/ajim.10257.
Results Reference
background
PubMed Identifier
20642198
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.
Results Reference
result
PubMed Identifier
20831465
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.
Results Reference
result
PubMed Identifier
19441600
Citation
Mancuso CA, Sayles W, Allegrante JP. Development and testing of the Asthma Self-Management Questionnaire. Ann Allergy Asthma Immunol. 2009 Apr;102(4):294-302. doi: 10.1016/S1081-1206(10)60334-1.
Results Reference
derived
PubMed Identifier
18569235
Citation
Choi TN, Westermann H, Sayles W, Mancuso CA, Charlson ME. Beliefs about asthma medications: patients perceive both benefits and drawbacks. J Asthma. 2008 Jun;45(5):409-14. doi: 10.1080/02770900801971834.
Results Reference
derived

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

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