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

Pollution; Exposure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05395663
• Other study ID #: NIH # 5R01ES031669
• Secondary ID: R01ES031669
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2022
• Est. completion date: June 2024

Study information

• Verified date: March 2023
• Source: Oregon State University
• Contact: Molly Kile, ScD
• Phone: 541-737-1443
• Email: molly.kile[@]oregonstate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 215
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pollution; Exposure

Intervention

Behavioral:
• Community 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.

Locations

Country	Name	City	State
United States	Oregon State University	Corvallis	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Oregon State University	National Institute of Environmental Health Sciences (NIEHS), Oregon Health Authority

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health history - Blood pressure	National Health and Nutrition Examination Survey (NHANES) questionnaires for Blood Pressure	6 months and 12 months
Other	Health history - Diabetes	National Health and Nutrition Examination Survey (NHANES) questionnaires for Diabetes	6 months and 12 months
Other	Health history - Cardiovascular	National Health and Nutrition Examination Survey (NHANES) questionnaires for cardiovascular	6 months and 12 months
Other	Health history - Cancer	National Health and Nutrition Examination Survey (NHANES) questionnaires for cancer	6 months and 12 months
Other	Health history - Reproductive Health	National Health and Nutrition Examination Survey (NHANES) questionnaires for reproductive health	6 months and 12 months
Other	Health history - Anemia	National Health and Nutrition Examination Survey (NHANES) questionnaires for anemia	6 months and 12 months
Other	Patient-Reported Quality of life	Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale to assess health symptoms (pain, fatigue, mental health, physical health, social health and overall health	6 months and 12 months
Primary	Treatment implemented by homeowner that will reduce their exposure to arsenic, nitrate or lead in their drinking water	The 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.	12 months
Primary	Clean water sample	A 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)	12 months
Primary	Well Stewardship Behaviors	This 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.	6 and 12 months
Secondary	Health literacy	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; 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.	6 months and 12 months
Secondary	Risk perception	This 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.	6 months and 12 months