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

September 21, 2017 updated by: Institute of Health Economics, Canada

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant, Alcoholic, actively in treatment for alcoholism addiction

Exclusion Criteria:

  • Not pregnant, not in treatment/therapy for addiction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental
Intervention is pregnant women enrolled and using specialized breathalyzer device w face recognition technology linked to a cellphone
Device: specialized breathalyzer w face recognition technology
Other Names:
  • Soberlink
NO_INTERVENTION: Control Group
No intervention. No breathalyzer given. Access granted by participant to IHE to collect data from Alberta Health Services (medical records)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in FASD Birthrate Levels
Time Frame: 3 years
Binary- yes or no dx FASD within 3 years of birth
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Health Economics, Canada

Collaborators

Alberta Health services
University of Alberta
Alberta Innovates Health Solutions
SoberLink, LLC

Investigators

  • Principal Investigator: Andy Greenshaw, PhD, Department of Psychiatry, University of Alberta
  • Study Director: Egon Jonsson, PhD, Institute of Health Economics Executive Director and CEO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (ANTICIPATED)

November 1, 2018

Study Completion (ANTICIPATED)

November 1, 2018

Study Registration Dates

First Submitted

April 28, 2016

First Submitted That Met QC Criteria

April 29, 2016

First Posted (ESTIMATE)

May 3, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 21, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00055644

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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