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

NCT02759874 | Unknown

• 1 other identifier: Pro00055644
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alcoholism; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Change in FASD Birthrate Levels

  Binary- yes or no dx FASD within 3 years of birth

  3 years

Study Arms (2)

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

Control Group

NO INTERVENTION

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

Interventions

specialized breathalyzer w face recognition technology DEVICE

Also known as: Soberlink

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant, Alcoholic, actively in treatment for alcoholism addiction

You may not qualify if:

• Not pregnant, not in treatment/therapy for addiction

Sponsors & Collaborators

• Institute of Health Economics, Canada: lead
• University of Alberta: collaborator
• SoberLink, LLC: collaborator
• Alberta Innovates Health Solutions: collaborator
• Alberta Health services: collaborator

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Andy Greenshaw, PhD

  Department of Psychiatry, University of Alberta

  PRINCIPAL INVESTIGATOR

• Egon Jonsson, PhD

  Institute of Health Economics Executive Director and CEO

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 3, 2016
• Study Start: November 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: September 25, 2017

Record last verified: 2017-09