Clinical trial NCT05395663: Scalability of a Home Health Navigator Program to Reduce Arsenic, Nitrate, and Lead in Private Well Water
Official title: Effectiveness and Scalability of a Home Health Navigator Program to Reduce Environmental Hazards
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pollution; Exposure
Keywords: drinking water
arsenic
nitrate
lead
environmental pollution
ground water
home environment
water wells
health promotion
water pollutant
water pollution
water treatment
water purification
chemical water pollution
underground water
water quality
environmental carcinogens
environmental health
environmental exposure
environmental pollutant
toxic environmental substances
Lead sponsor: Oregon State University
Sponsor class: OTHER
Collaborators: name: Oregon Health Authority
name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2022-05-27
Enrollment: 98
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Approximately 34 million Americans rely on private wells to supply their drinking water. Private wells are excluded from the Safe Drinking Water Act. Consequently, people who use private wells have not benefited from pollution prevention activities mandated by this law. This is a public health concern because toxic chemicals such as arsenic, nitrate, and lead are frequently detected in drinking water provided by private wells at concentrations that exceed the Safe Drinking Water Act's maximum contaminant levels. Chronic exposure to toxics in drinking water increase the risk of several chronic diseases. Several states in the U.S. have implemented or are proposing legislative policies to require testing and treatment of private wells and it is critical that public health agencies offer a program to aid homeowners with adherence to these new policies. Subsequently, there is a need to determine if individual-level interventions would be more effective for promoting behaviors that would reduce, mitigate, or eliminate exposure to contaminated well water. Lay health care workers may be able to provide cost-effective counseling to promote environmental health decision making among homeowners that have contaminated wells. This study will involve a community efficacy trial that brings together university-based researchers, State and Local agencies, and Extension Services. The community efficacy trial will be implemented by community health navigators via the Extension service. Specifically, it will involve a randomized controlled trial in Oregon to test the acceptability, fidelity, scalability and efficacy of 2 different intervention arms to reduce harmful toxicant exposures through the adoption of appropriate well water treatment. Upon completion, it will will produce a private well safety intervention program that has been tested and modified through empirical research. By capturing the costs and retaining the most efficacious intervention components, our cooperative approach has a better chance of scalability into practice across multiple stakeholders (i.e. Extension services, state health agencies). This information has the potential to reduce health disparities in rural America that are related to a household's source of drinking water.


Eligibility criteria: Participants are eligible for the study if they 1) Reside in Oregon; 2) Are a homeowner with a private well; 3) Use a private well as the primary source of drinking water; 4) Currently live in the home with the private well and intend to live in the home for at least 12 months from now; 5) Be at least 21 years old; and 6) Be able to complete a questionnaire in English or Spanish.

Primary outcomes:
measure: Treatment implemented by homeowner that will reduce their exposure to arsenic, nitrate or lead in their drinking water
timeFrame: 12 months
measure: Clean water sample
timeFrame: 12 months
measure: Well Stewardship Behaviors
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Health literacy
timeFrame: 6 months and 12 months
measure: Risk perception
timeFrame: 6 months and 12 months
Other outcomes:
measure: Health history - Blood pressure
timeFrame: 6 months and 12 months
measure: Health history - Diabetes
timeFrame: 6 months and 12 months
measure: Health history - Cardiovascular
timeFrame: 6 months and 12 months
measure: Health history - Cancer
timeFrame: 6 months and 12 months
measure: Health history - Reproductive Health
timeFrame: 6 months and 12 months
measure: Health history - Anemia
timeFrame: 6 months and 12 months
measure: Patient-Reported Quality of life
timeFrame: 6 months and 12 months
Locations:
city: Corvallis
country: United States
facility: Oregon State University
state: Oregon
Study officials:
affiliation: Oregon State University
name: Molly Kile, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon State University
name: Veronica Irvin, PhD
role: PRINCIPAL_INVESTIGATOR
References: