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SHWS: Strong Heart Water Study

Sponsor
Johns Hopkins Bloomberg School of Public Health (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03725592
Collaborator
Columbia University (Other), Missouri Breaks Industries Research, Inc. (Other)
300
Enrollment
1
Location
2
Arms
53
Anticipated Duration (Months)
5.7
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Standard Treatment
  • Behavioral: Intensive Education
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Prevention
Official Title:
Participatory Interventions to Reduce Arsenic Exposure in American Indian Communities
Actual Study Start Date :
Jul 2, 2018
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard Treatment

Receives arsenic removal device and written instructions and phone calls on how to use the device (Arsenic Removal Device)

Other: Standard Treatment
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.
Other Names:
  • Arsenic Removal Device

    		•
    Experimental: Intensive Education

    Receives the Standard Treatment plus in-person visits and phone calls for follow-up (Community Participatory Arsenic Mitigation)

    Other: Standard Treatment
    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.
    Other Names:
  • Arsenic Removal Device

    • Behavioral: Intensive Education
    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.
    Other Names:
  • Community Participatory Arsenic Mitigation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Urine arsenic concentrations in household members [6 months post-installation of the arsenic removal device]

      (1a) urine arsenic concentrations among household members (in parts per billion, µg/L)

    Secondary Outcome Measures

    1. Arsenic concentrations in filtered water [6 months post-installation of the arsenic removal device]

      (2a) water arsenic concentrations from arsenic removal device (parts per billion, µg/L)

    2. Water usage from arsenic removal device [6 months post-installation of the arsenic removal device]

      (2b) water usage from removal device (from flow meter, in gallons)

    3. Biomarkers of cardiovascular disease [6 months post-installation of the arsenic removal device]

      (2c) biomarkers of cardiovascular disease (soluble adhesion molecules) in household members

    4. Biomarkers of diabetes [6 months post-installation of the arsenic removal device]

      (2d) biomarkers of diabetes (hemoglobin A1c) in household members

    5. Biomarkers of pulmonary function [6 months post-installation of the arsenic removal device]

      (2e.1) lower forced expiratory volume in 1 second (FEV1) (actual performance in liters of air, percent of predicted values)

    6. Biomarkers of pulmonary function [6 months post-installation of the arsenic removal device]

      (2e.2) lower forced vital capacity (FVC) among household members (actual performance in liters of air, percent of predicted values)

    7. Blood pressure [6 months post-installation of the arsenic removal device]

      (2f) systolic and diastolic blood pressure levels

    8. Long-term urine arsenic concentrations in household members [1 year post-installation of the arsenic removal device]

      (2g) long-term sustainability assessment to evaluate arsenic concentrations in urine among household members (parts per billion, µg/L)

    9. Long-term functionality of arsenic removal device [1 year post-installation of the arsenic removal device]

      (2h) long-term sustainability assessment to evaluate water arsenic concentrations from arsenic removal device (parts per billion, µg/L)

    10. Long-term water usage from arsenic removal device [1 year post-installation of the arsenic removal device]

      (2i) long-term sustainability assessment to evaluate water usage from removal device (from flow meter, in gallons)

    11. Long-term maintenance of arsenic removal device [1 year post-installation of the 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)?)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins Bloomberg School of Public Health, ICTR Baltimore Maryland United States 21202

    Sponsors and Collaborators

    • Johns Hopkins Bloomberg School of Public Health
    • Columbia University
    • Missouri Breaks Industries Research, Inc.

    Investigators

    • Principal Investigator: Christine Marie George, PhD, Johns Hopkins Bloomberg School of Public Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johns Hopkins Bloomberg School of Public Health
    ClinicalTrials.gov Identifier:
    NCT03725592
    Other Study ID Numbers:
    • IRB00006504
    First Posted:
    Oct 31, 2018
    Last Update Posted:
    Jan 28, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Johns Hopkins Bloomberg School of Public Health
    arsenic
    drinking water
    Additional relevant MeSH terms:
    Arsenic Poisoning
    Poisoning

    Study Results

    No Results Posted as of Jan 28, 2022