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

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ClinicalTrials.gov Identifier: NCT02759874
Recruitment Status : Enrolling by invitation
First Posted : May 3, 2016
Last Update Posted : September 25, 2017
Sponsor:
Collaborators:
University of Alberta
SoberLink, LLC
Alberta Innovates Health Solutions
Alberta Health Services
Information provided by (Responsible Party):
Institute of Health Economics, Canada

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.


Condition or disease Intervention/treatment Phase
Alcoholism Pregnancy Device: specialized breathalyzer w face recognition technology Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Fetal Alcohol Spectrum Disorder (FASD) by the Use of Technology
Study Start Date : November 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


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 Name: 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)



Primary Outcome Measures :
  1. Change in FASD Birthrate Levels [ Time Frame: 3 years ]
    Binary- yes or no dx FASD within 3 years of birth



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant, Alcoholic, actively in treatment for alcoholism addiction

Exclusion Criteria:

  • Not pregnant, not in treatment/therapy for addiction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02759874


Sponsors and Collaborators
Institute of Health Economics, Canada
University of Alberta
SoberLink, LLC
Alberta Innovates Health Solutions
Alberta Health Services
Investigators
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Principal Investigator: Andy Greenshaw, PhD Department of Psychiatry, University of Alberta
Study Director: Egon Jonsson, PhD Institute of Health Economics Executive Director and CEO

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Responsible Party: Institute of Health Economics, Canada
ClinicalTrials.gov Identifier: NCT02759874     History of Changes
Other Study ID Numbers: Pro00055644
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
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Alcoholism
Fetal Alcohol Spectrum Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders