The Duke-Reinvestment Partners Community Collaborative (DRC)- Healthy Homes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Patient Satisfaction
研究概览
简要总结
The goal of this open-label, single arm home intervention feasibility study is to improve quality of life for children ages 4-16 years with asthma.
The main questions it aims to answer are:
- How can Home-Based Environmental Interventions (HEI) improve home air-quality problems in the home?
- How can HEI improve asthma outcomes in children?
Participants will be receiving HEI and completing asthma surveys.
详细描述
All participants will receive an Intervention Kit, which could help with reducing environmental exposures. Participants will be monitored closely with up to 2 clinic visits, 2 home visits and up to 4 phone call visits. During the home visits, a study team will ask questions about your home and asthma, conduct home assessments, and provide training on use of the home kit.
Participants may benefit from participation in this study through Home-Based Environmental Interventions by improving home air-quality and asthma outcomes. Study duration is approximately 24-30 weeks with 8 weeks of intervention, which includes baseline interview, questionnaires, spirometry testing, and participants receiving an Intervention Kit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 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)
- •4-16 years of age with medical provider -diagnosed asthma
- •Evidence of recent poor asthma control, defined as either:
- •Asthma exacerbation requiring systemic steroids within 3 month of consent OR
- •ACQ6 > 1.0; or ACT/cACT ≤ 19 during ambulatory visit within 3 months of consent
- •Family lives in one of the following Central NC counties: Alamance, Chatham, Durham, Franklin, Granville, Johnston, Lee, Orange, Person, Vance, or Wake counties
- •Family is not planning to move out of one of the approved counties accessible to Reinvestment Partners in the next 6 months
排除标准
- •Lack of informed consent
- •Any major chronic illness that in the opinion of the Principal Investigator (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
- •Parent/Caregiver unable to consent in English or Spanish
- •Sensitivity or allergy to silicone
结局指标
主要结局
Patient Satisfaction
时间窗: Week 10
A measure of satisfaction by distributing a satisfaction survey to each patient and caregiver
Asthma healthcare utilization measured by number of clinic visits needed
时间窗: Through study completion, an average of 24 weeks
Determine ongoing need for healthcare utilization for participant's asthma
Asthma healthcare utilization measured by number of Emergency Department visits
时间窗: Through study completion, an average of 24 weeks
Determine ongoing need for healthcare utilization for participant's asthma
Asthma healthcare utilization measured by number of urgent care visits
时间窗: Through study completion, an average of 24 weeks
Determine ongoing need for healthcare utilization for participant's asthma
Asthma healthcare utilization measured by number of hospitalizations
时间窗: Through study completion, an average of 24 weeks
Determine ongoing need for healthcare utilization for participant's asthma
Caregiver Satisfacation Survey
时间窗: Week 10
A measure of satisfaction by distributing a satisfaction survey to each patient and caregiver
Change in Air -Quality Index
时间窗: Week 4, Week 10
Air-quality index assessments will include: PM2.5, PM10, total VOC's, formaldehyde, carbon dioxide, Air Quality Index) in child's room and main living room using the Temtop M10, Temptop 2000C, and HEPA purifier air quality monitor.
次要结局
- Study Completion(Through study completion, an average of 24 weeks)
- Change in Air Quality of TVOC measured by a Temtop M10(Week 8)
- Change in Air Quality of Formaldehyde measured by a Temtop M10(Week 8)
- Change in Air Quality of Particulate Matter (PM) measured by a Temtop M10(Week 8)
- Change in Air Quality measured by a Temtop M10(Week 8)
- Air Quality changes of Particulate Matter (PM) 2.5 measured by a Temtop M2000c(Week 8)
- Air Quality changes of particles measured by a Temtop M2000c(Week 8)
- Air Quality changes of carbon dioxide measured by a Temtop M2000c(Week 8)
- Air Quality changes of particulate matter (PM 10) measured by a Temtop M2000c(Week 8)
- Measurement of lung function(Week 10)
- Asthma symptoms measured by the Asthma Control Test (ACT or cACT)(Week 10)
- Air Quality changes measured by patient's air purifier(Week 8)
- Asthma Symptoms measured by the Asthma Control Questionnaire (ACQ 6)(Week 10)
- Asthma symptoms measured by the Duke Asthma Score (DAS)(Week 10)