Prevention of Fetal Alcohol Spectrum Disorder (FASD) by the Use of Technology
NCT ID: NCT02759874
Last Updated: 2017-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
110 participants
INTERVENTIONAL
2015-11-30
2018-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental
Intervention is pregnant women enrolled and using specialized breathalyzer device w face recognition technology linked to a cellphone
specialized breathalyzer w face recognition technology
Control Group
No intervention. No breathalyzer given. Access granted by participant to IHE to collect data from Alberta Health Services (medical records)
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
specialized breathalyzer w face recognition technology
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Alberta
OTHER
SoberLink, LLC
INDUSTRY
Alberta Innovates Health Solutions
OTHER
Alberta Health services
OTHER
Institute of Health Economics, Canada
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andy Greenshaw, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Psychiatry, University of Alberta
Egon Jonsson, PhD
Role: STUDY_DIRECTOR
Institute of Health Economics Executive Director and CEO
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00055644
Identifier Type: -
Identifier Source: org_study_id