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
About this trial
This is an interventional prevention trial for Alcoholism
Eligibility Criteria
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
NCT ID
NCT02759874
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
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
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