Women of Color and Asthma Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 422
- 试验地点
- 2
- 主要终点
- Emergency department visits - 1st time point
研究概览
简要总结
The proposed randomized controlled trial will evaluate an innovative intervention in 420 African American women with asthma. It will be the first to use a highly tailored, telephone counseling approach to address both specific cultural factors affecting asthma and the influence of female sex and gender on control.
详细描述
Research and practice efforts in asthma continue to overlook one of the most vulnerable subgroups of Americans, minority women. Women of color, especially African Americans, bear a significantly disproportionate burden of asthma among adults. However, no rigorous trial of an intervention to assist them with their particular challenges can be located. The proposed randomized controlled trial will evaluate an innovative intervention in 420 African American women with asthma. It will be the first to address both specific cultural factors affecting asthma and the influence of female sex and gender on control. It will use a highly tailored, telephone counseling approach designed to foster partnership with the clinician, resolution of specific asthma management problems, and identification of important contributing influences often misunderstood or ignored by women themselves as well as the health care system. It will attend closely to the role of allergy in asthma management as patients in the African American population have been shown to be at greater risk for allergic asthma.
Data will be collected at baseline, 12, and 24 months by telephone interview and from medical records. The hypotheses of the research are that women in the intervention group when compared to the control group will:
- Use emergency department services for asthma less frequently and need urgent care in a physician's office less often;
- Be hospitalized for asthma less frequently.
- Experience fewer symptoms of asthma;
- Have higher levels of asthma-related quality of life
The intervention aims to reduce the burden of asthma as carried by a large subgroup of the adult population. It employs state of the art asthma management strategies and creative means to reach and help patients at high risk of asthma exacerbations and health care use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The study participants will be a non-institutionalized ambulatory sample of women who are willing to participate in the project and meet the following criteria:
- •Self-identify as African-American
- •18 years of age or older
- •Are listed on the University of Michigan Health System (UMHS) Asthma Patient Registry, a validated, all-payer registry of patients with persistent asthma cared for within the UM Health System
- •Have access to a telephone or cell phone
- •Are not pregnant.. Because the UMHS Asthma Patient Registry is validated, there is minimal risk of diagnostic misclassification. The Registry is created and maintained with a two-step process of identification and validation. UMHS patients with persistent asthma are initially identified through the electronic medical record using National Committee for Quality Assurance (NCQA) Healthcare Effectiveness Data and Information Set (HEDIS) criteria, billing and claims data (when available), and then are validated using documented clinical diagnoses, pulmonary function test (PFT) results, or clinician review.
排除标准
- •Patients with chronic respiratory conditions, including cystic fibrosis and chronic obstructive pulmonary disease (COPD) are excluded
结局指标
主要结局
Emergency department visits - 1st time point
时间窗: 12months prior to baseline interview
We will collect health care utilization data related to asthma. Women in the study will be asked during their baseline telephone interview to provide information regarding the frequency of Emergency Department visits related to asthma during the year prior to the baseline interview. Second, women's CareWeb and billing records will be reviewed for asthma related ED visits during this time period.
Emergency Department Visits - 3rd time point
时间窗: Interval between 12 month and 24 month telephone interview
We will collect health care utilization data related to asthma. Women in the study will be asked during the THIRD TELEPHONE INTERVIEW to provide information regarding the frequency of Emergency Department visits related to asthma for their year between their 12 month and 24 month telephone interview. In addition, we will review their CareWeb and billing record data for that time period to see if there are any asthma related Emergency Department visits.
Emergency Department Visits -2nd time point
时间窗: Interval between baseline interview and 12 month interview
We will collect health care utilization data related to asthma. Women in the study will be asked during the SECOND TELEPHONE INTERVIEW to provide information regarding the frequency of Emergency Department visits related to asthma for their year between their baseline and 12month interview. In addition, we will review their CareWeb and billing record data for that time period to see if there are any asthma related Emergency Department visits.
次要结局
- Hospitalizations - first time point(Year prior to baseline interview)
- Hospitalizations related to asthma - 2nd time point(interval between baseline and 12 month interview)
- Hospitalizations related to asthma - 3rd time point(interval between 12month and 24 month telephone interview)
研究者
Randall Brown
PI
University of Michigan
