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Scalability of a Home Health Navigator Program to Reduce Arsenic, Nitrate, and Lead in Private Well Water

Effectiveness and Scalability of a Home Health Navigator Program to Reduce Environmental Hazards

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05395663
Enrollment
98
Registered
2022-05-27
Start date
2022-06-16
Completion date
2025-06-30
Last updated
2025-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

BEHAVIORALCommunity health worker

A trained navigator (e.g. OSU Extension staff) will have 3 meetings with the participants in Arm 2. These meetings will be held in person, on the phone, or in zoom.

Sponsors

Oregon Health Authority
CollaboratorOTHER
National Institute of Environmental Health Sciences (NIEHS)
CollaboratorNIH
Oregon State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Masking description

The care providers are the OSU Extension Service agents serving as the navigators in the intervention arm and the Oregon Health Authority as the usual care arm. They will not know participants assigned to the other arms. Biostatistician will evaluate the effectiveness of the intervention without knowing the condition of the participants.

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Treatment implemented by homeowner that will reduce their exposure to arsenic, nitrate or lead in their drinking water12 monthsThe homeowner has adopted behaviors that will be appropriate for reducing their exposure to arsenic, nitrate, and lead in their drinking water. This will be assessed based on the homeowners response on a survey delivered after 12 month. Appropriate treatment will be defined as the use of drinking water technology that removes the contaminant detected (e.g. reverse osmosis, distillation, arsenic removal filter, or removal of lead-based water fixtures) or switching to bottled water for drinking and cooking.
Clean water sample12 monthsA water sample that is collected from their home's kitchen faucet is tested by a certified laboratory and the contaminant of concern (arsenic, nitrate, or lead) is below its maximum contaminant level (arsenic \< 10ug/L; nitrate \<10mg/L, and lead \<15 ug/L)
Well Stewardship Behaviors6 and 12 monthsThis will be assessed based on questions in the homeowner survey which asks the participants what actions they take to test, treat, and maintain the water quality that is coming from their private well.

Secondary

MeasureTime frameDescription
Health literacy6 months and 12 months1. Water Environmental Literacy Level Scale - WELLS is a 6-item scale. The reference for this is: Irvin, V. L., Rohlman, D., Vaughan, A., Amantia, R., Berlin, C., & Kile, M. L. (2019). Development and Validation of an Environmental Health Literacy Assessment Screening Tool for Domestic Well Owners: The Water Environmental Literacy Level Scale (WELLS). International journal of environmental research and public health, 16(5), 881. doi:10.3390/ijerph16050881 2. Brief Health Literacy Screener (Chew Items) is a 3-item scale. The reference for this: Chew, L.D., Bradley, K.A., & Boyko, E.J. (2004). Brief questions to identify patients with inadequate health literacy. Family Medicine, 36(8): 588-594.
Risk perception6 months and 12 monthsThis will be assessed our homeowner survey which includes a condensed form of the RANAS (Risk, Attitude, Norms, Ability, Self-Regulation) Scales published in Flannigan et al (2015) Dissemination of well water arsenic results to homeowners in Central Maine: influences on mitigation behavior and continued risks for exposure. Sci Total Environ, 505: 1282-90.

Other

MeasureTime frameDescription
Health history - Anemia6 months and 12 monthsNational Health and Nutrition Examination Survey (NHANES) questionnaires for anemia
Health history - Blood pressure6 months and 12 monthsNational Health and Nutrition Examination Survey (NHANES) questionnaires for Blood Pressure
Patient-Reported Quality of life6 months and 12 monthsPatient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale to assess health symptoms (pain, fatigue, mental health, physical health, social health and overall health
Health history - Diabetes6 months and 12 monthsNational Health and Nutrition Examination Survey (NHANES) questionnaires for Diabetes
Health history - Cardiovascular6 months and 12 monthsNational Health and Nutrition Examination Survey (NHANES) questionnaires for cardiovascular
Health history - Cancer6 months and 12 monthsNational Health and Nutrition Examination Survey (NHANES) questionnaires for cancer
Health history - Reproductive Health6 months and 12 monthsNational Health and Nutrition Examination Survey (NHANES) questionnaires for reproductive health

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026