Viewing Study NCT00124085



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Study NCT ID: NCT00124085
Status: COMPLETED
Last Update Posted: 2012-08-09
First Post: 2005-07-22

Brief Title: Asthma in a Decentralized Patient Population Is Traditional Disease Management Enough
Sponsor: The University of Texas Health Science Center at San Antonio
Organization: The University of Texas Health Science Center at San Antonio

Study Overview

Official Title: Asthma in a Decentralized Patient Population Is Traditional Disease Management Enough A Randomized Controlled Trial Comparing Traditional Care to Two Systems of Disease Management for a Decentralized Population of Patients in South Texas
Status: COMPLETED
Status Verified Date: 2012-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 patientfamily 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 populations access to care
Detailed Description: This trial addresses the real-world concerns of asthma management through a disease management approach that will assist both the patient and the primary care physician by providing education additional outpatient resources and additional access to health care personnel This approach will stress empowering the patient to participate in his or her own health care at a higher level which in the case of asthma is critical to wellness

In a cooperative network of San Antonio medical centers civilian and military with a collective mission to care for military beneficiaries and the underserved patients of South Texas this trial will evaluate the clinical benefits as well as the cost savings of a chronic disease management intervention in asthma This study will fill a conspicuous gap in the medical literature by addressing the effectiveness of disease management through a large decentralized randomized controlled trial

DISEASE MANAGEMENT INTERVENTION

The project will use asthma disease management protocols and educational materials developed by the National Jewish Medical and Research Center The program will be fully available in both English and Spanish allowing a direct test of its impact on the States vulnerable Hispanic population Based on the principles of comprehensive disease management National Jewish Medical and Research Center has developed a disease management program for asthma DMP Asthma which addresses continuity of care by integrating traditional treatment methods with a program that focuses on creating a stronger partnership between the patient and the healthcare team as well as greater patient empowerment The primary program goal is empowering patients with the tools and resources they need for better self management of their prescribed treatment regimens and control of their environment The program incorporates practice guidelines outlined by the National Heart Lung and Blood Institute NHLBI at the National Institutes of Health NIH

HOME VISIT INTERVENTION

In addition the demonstration will evaluate the addition of a home-based disease management protocol focusing on patient education to test for incremental improvement Patients will be taught about their disease symptoms treatment appropriate action plans as well as about the healthcare system how and when to access it Based on the principles of comprehensive disease management and the unique needs of South Texas residents the South Texas Asthma Management Program STAMP is designed for a diverse mobile underserved patient population The protocol delivers up-front home-based education and environmental assessment with follow-up visits focused on reinforcement of the earlier messages The program ensures access to a primary care provider for patients who lack this critical member of the healthcare team It also provides multiple resources for social services and guidance in appropriately accessing the healthcare system The goal of the program is to equip patients who have barriers to access due to a number of factors lack of phone language remote location etc to navigate the healthcare system and effectively receive the care they need

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None