Strong Heart Water Study (SHWS)
Primary Purpose
Arsenic Poisoning
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Treatment
Intensive Education
Sponsored by
About this trial
This is an interventional prevention trial for Arsenic Poisoning focused on measuring arsenic, drinking water
Eligibility Criteria
Inclusion Criteria:
- Arsenic levels in household drinking water must be ≥10 µg/L
- Households must have ≥1 adult ≥18 years of age eligible and willing to participate.
- Household must have an active well on the property that is used for drinking water.
- Household must have indoor plumbing and a permanent heat source.
- Participant must plan to reside in the household for the next year, must reside in the residence for ≥4 days/week, and year round (i.e. all seasons).
- ≥1 household members must identify as American Indian.
- Household must be willing to grant study members access to the interior of their household for screening and data collection.
Exclusion Criteria:
- Arsenic levels in household drinking water <10 µg/L
- Households with no adult ≥18 years of age eligible and willing to participate.
- Households without an active well on the property that is used for drinking water (i.e. connected to municipal water supply).
- Households without indoor plumbing and/or a permanent heat source.
- Participant planning to reside in the household <1 year, residing in the residence for <4 days/week, or not year round (i.e. not during all seasons).
- No household member identifies as American Indian.
- Household unwilling to grant study members access to the interior of their household for screening and data collection.
Sites / Locations
- Johns Hopkins Bloomberg School of Public Health, ICTR
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Treatment
Intensive Education
Arm Description
Receives arsenic removal device and written instructions and phone calls on how to use the device (Arsenic Removal Device)
Receives the Standard Treatment plus in-person visits and phone calls for follow-up (Community Participatory Arsenic Mitigation)
Outcomes
Primary Outcome Measures
Urine arsenic concentrations in household members
(1a) urine arsenic concentrations among household members (in parts per billion, µg/L)
Secondary Outcome Measures
Arsenic concentrations in filtered water
(2a) water arsenic concentrations from arsenic removal device (parts per billion, µg/L)
Water usage from arsenic removal device
(2b) water usage from removal device (from flow meter, in gallons)
Biomarkers of cardiovascular disease
(2c) biomarkers of cardiovascular disease (soluble adhesion molecules) in household members
Biomarkers of diabetes
(2d) biomarkers of diabetes (hemoglobin A1c) in household members
Biomarkers of pulmonary function
(2e.1) lower forced expiratory volume in 1 second (FEV1) (actual performance in liters of air, percent of predicted values)
Biomarkers of pulmonary function
(2e.2) lower forced vital capacity (FVC) among household members (actual performance in liters of air, percent of predicted values)
Blood pressure
(2f) systolic and diastolic blood pressure levels
Long-term urine arsenic concentrations in household members
(2g) long-term sustainability assessment to evaluate arsenic concentrations in urine among household members (parts per billion, µg/L)
Long-term functionality of arsenic removal device
(2h) long-term sustainability assessment to evaluate water arsenic concentrations from arsenic removal device (parts per billion, µg/L)
Long-term water usage from arsenic removal device
(2i) long-term sustainability assessment to evaluate water usage from removal device (from flow meter, in gallons)
Long-term maintenance of arsenic removal device
(2j) long-term sustainability assessment to evaluate self-reported maintenance of the arsenic removal device (Did household change the device filter when indicated by light on spigot? Does household have replacement filter(s) available for subsequent filter change(s)?)
Full Information
NCT ID
NCT03725592
First Posted
July 6, 2018
Last Updated
June 26, 2023
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Columbia University, Missouri Breaks Industries Research, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03725592
Brief Title
Strong Heart Water Study
Acronym
SHWS
Official Title
Participatory Interventions to Reduce Arsenic Exposure in American Indian Communities
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2, 2018 (Actual)
Primary Completion Date
May 4, 2024 (Anticipated)
Study Completion Date
May 4, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Columbia University, Missouri Breaks Industries Research, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Develop and evaluate the effectiveness of multi-level participatory interventions in reducing arsenic exposure among American Indian (AI) communities from North and South Dakota who participated in the Strong Heart Study (SHS).
Detailed Description
Design, implement, and evaluate multi-level participatory interventions that can lead to a sustained reduction in arsenic exposure in adults and children in Cheyenne River, Oglala, and Spirit Lake communities in North/South Dakota by: 1) building local capacity at the tribal and community levels to ensure the long-term sustainability of the interventions. 2) conduct a 2-arm cluster-randomized controlled trial comparing arsenic removal device only to removal device and intensive education and promotion among 300 households, 600 participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arsenic Poisoning
Keywords
arsenic, drinking water
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Recruit and prospectively follow 300 households and 600 participants (2 per household) to one of 2 study arms (150 households per arm). Each arm will receive arsenic removal devices. However the Standard Arm will only be provided with written instructions on how to use the arsenic removal device and follow-up phone calls, while the Intensive Education Arm will receive up to 5 additional in-visits and phone calls to provide support regarding the health implications of arsenic and the proper use and maintenance of the arsenic removal device.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Treatment
Arm Type
Active Comparator
Arm Description
Receives arsenic removal device and written instructions and phone calls on how to use the device (Arsenic Removal Device)
Arm Title
Intensive Education
Arm Type
Experimental
Arm Description
Receives the Standard Treatment plus in-person visits and phone calls for follow-up (Community Participatory Arsenic Mitigation)
Intervention Type
Other
Intervention Name(s)
Standard Treatment
Other Intervention Name(s)
Arsenic Removal Device
Intervention Description
Participant households receive a point of use arsenic removal device and a replacement filter. Households are also provided with an instruction manual on how to use the device.
Intervention Type
Behavioral
Intervention Name(s)
Intensive Education
Other Intervention Name(s)
Community Participatory Arsenic Mitigation
Intervention Description
Participant households receive up to five additional in-person visits and phone calls to provide support regarding the health implications of arsenic and the proper use and maintenance of the arsenic removal device.
Primary Outcome Measure Information:
Title
Urine arsenic concentrations in household members
Description
(1a) urine arsenic concentrations among household members (in parts per billion, µg/L)
Time Frame
6 months post-installation of the arsenic removal device
Secondary Outcome Measure Information:
Title
Arsenic concentrations in filtered water
Description
(2a) water arsenic concentrations from arsenic removal device (parts per billion, µg/L)
Time Frame
6 months post-installation of the arsenic removal device
Title
Water usage from arsenic removal device
Description
(2b) water usage from removal device (from flow meter, in gallons)
Time Frame
6 months post-installation of the arsenic removal device
Title
Biomarkers of cardiovascular disease
Description
(2c) biomarkers of cardiovascular disease (soluble adhesion molecules) in household members
Time Frame
6 months post-installation of the arsenic removal device
Title
Biomarkers of diabetes
Description
(2d) biomarkers of diabetes (hemoglobin A1c) in household members
Time Frame
6 months post-installation of the arsenic removal device
Title
Biomarkers of pulmonary function
Description
(2e.1) lower forced expiratory volume in 1 second (FEV1) (actual performance in liters of air, percent of predicted values)
Time Frame
6 months post-installation of the arsenic removal device
Title
Biomarkers of pulmonary function
Description
(2e.2) lower forced vital capacity (FVC) among household members (actual performance in liters of air, percent of predicted values)
Time Frame
6 months post-installation of the arsenic removal device
Title
Blood pressure
Description
(2f) systolic and diastolic blood pressure levels
Time Frame
6 months post-installation of the arsenic removal device
Title
Long-term urine arsenic concentrations in household members
Description
(2g) long-term sustainability assessment to evaluate arsenic concentrations in urine among household members (parts per billion, µg/L)
Time Frame
1 year post-installation of the arsenic removal device
Title
Long-term functionality of arsenic removal device
Description
(2h) long-term sustainability assessment to evaluate water arsenic concentrations from arsenic removal device (parts per billion, µg/L)
Time Frame
1 year post-installation of the arsenic removal device
Title
Long-term water usage from arsenic removal device
Description
(2i) long-term sustainability assessment to evaluate water usage from removal device (from flow meter, in gallons)
Time Frame
1 year post-installation of the arsenic removal device
Title
Long-term maintenance of arsenic removal device
Description
(2j) long-term sustainability assessment to evaluate self-reported maintenance of the arsenic removal device (Did household change the device filter when indicated by light on spigot? Does household have replacement filter(s) available for subsequent filter change(s)?)
Time Frame
1 year post-installation of the arsenic removal device
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Arsenic levels in household drinking water must be ≥10 µg/L
Households must have ≥1 adult ≥18 years of age eligible and willing to participate.
Household must have an active well on the property that is used for drinking water.
Household must have indoor plumbing and a permanent heat source.
Participant must plan to reside in the household for the next year, must reside in the residence for ≥4 days/week, and year round (i.e. all seasons).
≥1 household members must identify as American Indian.
Household must be willing to grant study members access to the interior of their household for screening and data collection.
Exclusion Criteria:
Arsenic levels in household drinking water <10 µg/L
Households with no adult ≥18 years of age eligible and willing to participate.
Households without an active well on the property that is used for drinking water (i.e. connected to municipal water supply).
Households without indoor plumbing and/or a permanent heat source.
Participant planning to reside in the household <1 year, residing in the residence for <4 days/week, or not year round (i.e. not during all seasons).
No household member identifies as American Indian.
Household unwilling to grant study members access to the interior of their household for screening and data collection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Marie George, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bloomberg School of Public Health, ICTR
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Strong Heart Water Study
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