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临床试验/NCT00124085
NCT00124085已完成不适用

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

The University of Texas Health Science Center at San Antonio0 个研究点目标入组 1,053 人开始时间: 2003年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,053
主要终点
Symptom-free days

研究概览

简要总结

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.

详细描述

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 State's 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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single

入排标准

年龄范围
5 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

次要结局

  • Pulmonary function testing
  • SF-36
  • Days of school/work missed
  • Drug usage

研究者

申办方类型
Other
责任方
Sponsor

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