Developing a Hybrid Type 1 Effectiveness-Implementation Randomized Controlled Trial to Test a Table-Top Water Pitcher to Reduce Arsenic Exposure in Northern New England
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Water arsenic concentrations
研究概览
简要总结
The goals of this clinical trial are to:
- gather preliminary data on the effectiveness of a table-top water pitcher filtration system in reducing arsenic exposure among individuals using private wells with elevated (>5 μg/L) arsenic concentrations, and
- identify the factors influencing implementation of the filter intervention (uptake and sustainability) and barriers and facilitators to its use.
The main questions it aims to answer are:
Do water and urinary arsenic concentrations change from baseline to Week 4 of the water pitcher intervention?
Are changes in arsenic concentrations maintained during the eight-week sustainability period?
- Which factors facilitate or impede uptake, use, and sustainability of the intervention?
- Are household income and/or home ownership associated with sustained filter use?
Participants will:
- Receive a free 12-cup water filter pitcher and cartridge replacements
- Use the pitcher filtration system, including replacement of filter cartridges, per manufacturer recommendations
- Collect and mail water and urine samples at baseline, 4 weeks, and 12 weeks
- Complete online questionnaires at baseline, 4 weeks, and 12 weeks
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •NH resident living in Merrimack or Belknap county
- •Use a private water system as primary drinking water source
- •Water arsenic >5 micrograms/L upon testing
- •Confirm would be primary person in home maintaining the provided pitcher filter
排除标准
- •Use or plan to use a mitigation strategy to reduce exposure to arsenic-contaminated drinking water in the next 12 weeks
研究组 & 干预措施
Water Pitcher Filtration System
Arm 1: All participants receive pitcher filter and three replacement filters
干预措施: Water Pitcher Filtration System (Behavioral)
结局指标
主要结局
Water arsenic concentrations
时间窗: 4 weeks
Changes in water arsenic concentrations from baseline to week 4
Urinary arsenic concentrations
时间窗: 4 weeks
Changes in urinary arsenic concentrations from baseline to week 4
Reach
时间窗: 4 weeks
Number of participants who receive the water pitcher filtration system among all eligible individuals and demographics
Adoption
时间窗: 4 weeks
Number of participants using the filtration system after receiving it; number of participants who intend to use the system after the study period ends; and demographics of participants who used the filtration system during the study period or intend to use it after the study period ends
Implementation
时间窗: 4 weeks
% of participants who adhere to the intervention during the intervention period (Fidelity), including using the pitcher filtration system for all drinking and cooking water and changing filter cartridges as recommended (measured by questionnaire: at home, did you use the pitcher filtration system for all of your drinking water, more than half of your drinking water, half of your drinking water, less than half of your drinking water, or none of your drinking water AND did you use did you use the pitcher filtration system for all of your cooking water, more than half of your cooking water, half of your cooking water, less than half of your cooking water, or none of your cooking water)
Maintenance
时间窗: 8 weeks
% of participants who continue to use the pitcher filtration system during the 8-week sustainability period when replacement filter cartridges are no longer provided (measured by questionnaire: at home, did you use the pitcher filtration system for all of your drinking water, more than half of your drinking water, half of your drinking water, less than half of your drinking water, or none of your drinking water AND did you use did you use the pitcher filtration system for all of your cooking water, more than half of your cooking water, half of your cooking water, less than half of your cooking water, or none of your cooking water)
次要结局
未报告次要终点
研究者
Caitlin G. Howe
Assistant Professor of Epidemiology
Trustees of Dartmouth College