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临床试验/NCT00201188
NCT00201188已完成不适用

Cueing Patient-Clinician Collaboration to Improve Asthma

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2003年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
139
试验地点
2
主要终点
Adherence to ICS medication

研究概览

简要总结

The purpose of this study is to improve anti-inflammatory medication adherence and asthma outcomes by using reports of peak flow monitoring to prompt communication between patients and their doctors.

详细描述

BACKGROUND:

Asthma is a chronic, potentially life-threatening disease that affects 17 million people in the United States. Asthma leads to millions of lost work days and thousands of hospitalizations annually. For the millions of people with this disease, it is chronic but controllable. Corticosteroids are the most effective medication for the long-term treatment of persistent asthma, and inhaling the medication minimizes the potential for systemic side effects. Despite convincing evidence of the benefits of inhaled corticosteroids (ICS), both patients and doctors seem reluctant to use them regularly. Many people who are prescribed ICS either never take them, or take them less frequently (e.g., once rather than twice daily), less regularly (e.g., "as needed" rather than daily), or at lower doses than prescribed. Doctors agree that at least 50% of people who are prescribed ICS fail to benefit fully because of poor adherence. The many reasons for non-adherence are not fully understood. The relationship between the doctor and patient, an area in which potential impact can be made, is believed to be the strongest predictor of medication adherence. Providing pertinent information about asthma related lung function should prompt communication between the patient and doctor to improve adherence to ICS.

DESIGN NARRATIVE:

The overall purpose of this study is to improve anti-inflammatory medication adherence and asthma outcomes by encouraging communication between patients and their doctor. The specific aims of the study include the following: 1) improve adherence to ICS medication by encouraging patient-doctor communication with feedback of objective information about airflow obstruction to reinforce medication-taking behavior; and 2) document the impact that the encouragement of communication has on health care outcomes, including health care utilization, pulmonary function, need for rescue courses of oral steroids, and functional impact. The hypothesis of the study is that informing patients and their primary care doctors about the degree of airflow obstruction will prompt interaction between them resulting in greater adherence to ICS medication over one year than will occur in a control group of similar patients who do not receive feedback. Promoting communication between adults with asthma and their doctors in a primary care clinical setting has not yet been studied. All doctors within three general medicine practices and their adult patients with moderate to severe asthma will be enrolled and assigned to either the intervention or usual care. Feedback of interpreted peak flow graphs in relation to current medication therapy will prompt the communication. The intent is to encourage and support the relationship between the doctor and patient rather than to directly intervene. The power of encouraging communication lies in the ensuing dialogue between the doctor and patient. Improvement of adherence to ICS among people with moderate or severe asthma has been shown to decrease morbidity of asthma and improve health outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 72 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Currently using ICS
  • Planning to live in the San Francisco Bay Area in the year following study entry

排除标准

  • Diagnosis of any lung disease other than asthma
  • Has a smoking history greater than or equal to 15 pack-years
  • Psychological problems that may make monthly study visits impossible

结局指标

主要结局

Adherence to ICS medication

时间窗: Measured on a monthly basis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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