Durham Healthy Breathing in Healthy Homes Project: A Duke-Reinvestment Partners Collaborative
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Number of caregiver reporting satisfaction with intervention as measured by survey responses
研究概览
简要总结
To determine if Home-based Environmental Interventions (HEI) that improve home air-quality problems can improve asthma outcomes. Participants will benefit through home-based environmental interventions that improve home air-quality problems and improve asthma outcomes. All participants will receive a Breath Easy at Home Kit, which could help with reducing environmental exposures. The primary objective is to assess the feasibility and acceptability of the HEI measured by the proportion of families completing intervention components and proportion of caregivers expressing satisfaction with intervention components. Secondary objective is to explore the efficacy of a HEI on reducing environmental exposures measured using personal wristband monitors.
Exploratory objective is improvements in asthma control following HEI measured using asthma control scores and lung function. The fourth objection is to explore correlations between demographics, body weight, housing characteristics (smokers, electronic cigarette use, number of pets, housing type) with measures of acceptability, satisfaction and improved exposure markers.
详细描述
The investigator propses a 23-week prospective, open label, single center, environmental remediation intervention study in 5-16 year old children with poor asthma control. At visit 1, wristbands will be dispensed and collected to estimate exposure to a suite of common organic contaminants including phthalates, organophosphate esters, several pesticides and polyaromatic hydrocarbons (PAH). During the initial home visit, the Healthy Homes Housing Specialist will conduct an environmental home assessment to identify asthma triggers in accordance with the EPA's recommendations for helping children with asthma. The Housing Specialist will follow the EPA document Home Characteristics and Asthma Triggers, and will provide the family with a Breathe Easy at Home Kit. The Specialist will provide training and instructions on how to use each of the supplies provided in the kit. If the Housing Specialist identifies necessary home repairs during the assessment process, the Housing Specialist can refer the family to organizations that offer home repairs, modifications, and weatherization services. The specialist will discuss the importance of clean air for maintaining lung health for all family members and will discuss the importance of banning of any indoor smoking, smoking anywhere around the household and smoking in any household automobiles (even when the child is not present). Follow up phone calls will be conducted to answer questions, complete questionnaires and complete a household environmental interview.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent/legal guardian has provided informed consent (child has provided assent if needed)
- •5-16 years of age with physician-diagnosed asthma
- •Evidence of poor asthma control defined as either:
- •Hospitalization at Duke Children's Hospital within past 30 days or, ACQ6 > 1.0 during ambulatory visit to Duke Asthma Center within 2 weeks
排除标准
- •Lack of informed consent
- •Any major chronic illness that in the opinion of the PI would interfere with participation in the intervention or completion of the study procedures
- •Inability to complete baseline measurements in a satisfactory manner according to the judgment of the research coordinator or PI
- •Family is planning to move households in the next 2 months
- •Parent/Caregiver unable to consent in English
- •Sensitivity or allergy to silicone
结局指标
主要结局
Number of caregiver reporting satisfaction with intervention as measured by survey responses
时间窗: Four Month
Number of completed home visits as measured by completion logs
时间窗: 2 months
Number of completion of the post-intervention phone visit as measured by call logs
时间窗: Four Months
次要结局
- Change in Indoor Air Quality measured by questionnaire(3 weeks and 7 weeks)
- Change in Environmental Wristband Markers(3 weeks and 7 weeks)
- Change in Spirometry Values as measured by spirometric measures(1 week and 4 months)
- Change in Asthma Symptoms(1 week and 4 months)