Asthma in a Decentralized Patient Population: Is Traditional Disease Management Enough?

NCT00124085 | Completed

• 1 other identifier: 034-5001-057
• Study Type: interventional
• Target: 1,053
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a health services demonstration project that evaluates three methods of health care delivery for the management of individuals with symptoms of asthma. This study will evaluate the impact of a telephonic asthma disease management process, with and without a home intervention program, on preventing asthma-related morbidity through patient/family asthma education. The investigators' central thesis is that comprehensive clinical disease management protocols for the management of asthma will improve clinical outcomes; reduce fiscal resource consumption; and improve both patient satisfaction and patient quality of life. Additionally, individualized, in-home patient education and environmental assessment, when added to the telephonic protocol, will further improve these measures. However, incremental improvement will vary according to the population's access to care.

Conditions

Asthma

Outcome Measures

Primary Outcomes (4)

• Symptom-free days

• Quality of Life Questionnaire (AQLQ, PAQLQ)

• Rate of asthma-related hospitalizations over 18 months of enrollment

• Rate of asthma-related emergency room (ER) visits over 18 months of enrollment

Secondary Outcomes (4)

• Pulmonary function testing

• SF-36

• Days of school/work missed

• Drug usage

Interventions

Disease Management BEHAVIORAL

Disease Management + Educational Home Visits BEHAVIORAL

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician diagnosis of asthma
• One or more of the following:
• Acute visit with the primary diagnosis of asthma within the previous 6 months. (Includes visits to physician's office, emergency department, or any other health care facility.); OR
• Three or more refills for inhaler medicine in the past 6 months, based on review of pharmaceutical records; OR
• Diagnosis of asthma based on asthma symptoms and pulmonary function testing.

You may not qualify if:

• Other lung disease(s) with a possible reactive component (i.e. chronic obstructive pulmonary disease \[COPD\])
• Any diagnosis requiring chronic systemic steroids
• Enrollment in any other asthma disease management program
• Pregnancy
• Plan to reside at current residence for less than 12 months.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• South Texas Veterans Health Care System: collaborator
• Brooke Army Medical Center: collaborator
• 59th Medical Wing: collaborator
• TRICARE Southwest: collaborator
• Department of Health and Human Services: collaborator
• Centers for Disease Control and Prevention: collaborator

Related Publications (1)

• Galbreath AD, Smith B, Wood PR, Inscore S, Forkner E, Vazquez M, Fallot A, Ellis R, Peters JI. Assessing the value of disease management: impact of 2 disease management strategies in an underserved asthma population. Ann Allergy Asthma Immunol. 2008 Dec;101(6):599-607. doi: 10.1016/S1081-1206(10)60222-0.

  PMID: 19119703 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Disease Management

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient Care Management; Health Services Administration

Study Officials

• Gregory L Freeman, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

• Jay I Peters, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

• Stephen Inscore, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

• Autumn Dawn Galbreath, MD

  University of Texas

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2005
• First Posted: July 26, 2005
• Study Start: October 1, 2003
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: August 9, 2012

Record last verified: 2012-08