search
Back to results

Prevention of Fetal Alcohol Spectrum Disorder (FASD) by the Use of Technology

Primary Purpose

Alcoholism, Pregnancy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
specialized breathalyzer w face recognition technology
Sponsored by
Institute of Health Economics, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcoholism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Pregnant, Alcoholic, actively in treatment for alcoholism addiction

Exclusion Criteria:

  • Not pregnant, not in treatment/therapy for addiction

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental

    Control Group

    Arm Description

    Intervention is pregnant women enrolled and using specialized breathalyzer device w face recognition technology linked to a cellphone

    No intervention. No breathalyzer given. Access granted by participant to IHE to collect data from Alberta Health Services (medical records)

    Outcomes

    Primary Outcome Measures

    Change in FASD Birthrate Levels
    Binary- yes or no dx FASD within 3 years of birth

    Secondary Outcome Measures

    Full Information

    First Posted
    April 28, 2016
    Last Updated
    September 21, 2017
    Sponsor
    Institute of Health Economics, Canada
    Collaborators
    University of Alberta, SoberLink, LLC, Alberta Innovates Health Solutions, Alberta Health services
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02759874
    Brief Title
    Prevention of Fetal Alcohol Spectrum Disorder (FASD) by the Use of Technology
    Official Title
    Prevention of Fetal Alcohol Spectrum Disorder (FASD) by the Use of Technology
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    November 2018 (Anticipated)
    Study Completion Date
    November 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institute of Health Economics, Canada
    Collaborators
    University of Alberta, SoberLink, LLC, Alberta Innovates Health Solutions, Alberta Health services

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The Institute of Health Economics is conducting a study to determine how a breathalyzer linked to a cloud based alcohol monitoring system changes alcohol consumption during pregnancy in women with alcohol dependency issues. IHE posits that the ability to self-monitor blood alcohol concentration and the ability to share sobriety via email or text with loved ones and counselors may reduce alcohol consumption and thus reduce the possibility of delivering a child with FASD. The study will provide useful evidence for tailoring future optimal maternal and child healthcare for women, with the potential of decreasing healthcare utilization by prevention of FASD. Breathalyzer device usage plus secure document sobriety should improve patient monitoring convenience and demonstrate reductions in alcohol use outside of traditional office visits and patient self-reports.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcoholism, Pregnancy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    110 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    Intervention is pregnant women enrolled and using specialized breathalyzer device w face recognition technology linked to a cellphone
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    No intervention. No breathalyzer given. Access granted by participant to IHE to collect data from Alberta Health Services (medical records)
    Intervention Type
    Device
    Intervention Name(s)
    specialized breathalyzer w face recognition technology
    Other Intervention Name(s)
    Soberlink
    Primary Outcome Measure Information:
    Title
    Change in FASD Birthrate Levels
    Description
    Binary- yes or no dx FASD within 3 years of birth
    Time Frame
    3 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Pregnant, Alcoholic, actively in treatment for alcoholism addiction Exclusion Criteria: Not pregnant, not in treatment/therapy for addiction
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andy Greenshaw, PhD
    Organizational Affiliation
    Department of Psychiatry, University of Alberta
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Egon Jonsson, PhD
    Organizational Affiliation
    Institute of Health Economics Executive Director and CEO
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Prevention of Fetal Alcohol Spectrum Disorder (FASD) by the Use of Technology

    We'll reach out to this number within 24 hrs