AlcoholismNCT02759874
Prevention of Fetal Alcohol Spectrum Disorder (FASD) by the Use of Technology
A study testing specialized breathalyzer w face recognition technology in people with Alcoholism and Pregnancy, run by Institute of Health Economics, Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alcoholism, Pregnancy
- What is being tested?
- specialized breathalyzer w face recognition technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant, Alcoholic, actively in treatment for alcoholism addiction
Who cannot join
- Not pregnant, not in treatment/therapy for addiction
About this study
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
- Being tested
- specialized breathalyzer w face recognition technology
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specialized breathalyzer w face recognition technologyDevice
Also called Soberlink
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Intervention is pregnant women enrolled and using specialized breathalyzer device w face recognition technology linked to a cellphone Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FASD Birthrate Levels
Binary- yes or no dx FASD within 3 years of birth
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startNov 2015
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Health Economics, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta, SoberLink, LLC, Alberta Innovates Health Solutions, Alberta Health services
- Responsible party
- Sponsor
- Investigators
- Andy Greenshaw, PhD, Principal investigator, Department of Psychiatry, University of AlbertaEgon Jonsson, PhD, Study director, Institute of Health Economics Executive Director and CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759874
- Sponsor's protocol ID
- Pro00055644
- Status last verified
- Sep 2017
- First submitted
- 28 Apr 2016
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Fetal Alcohol Spectrum Disorder (FASD) by the Use of Technology
- ClinicalTrials.gov ID
- NCT02759874
- Acronym / sponsor ID
- Pro00055644
- Conditions
- Alcoholism, Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Institute of Health Economics, CanadaUniversity, hospital or other
- Collaborators
- University of Alberta, SoberLink, LLC, Alberta Innovates Health Solutions, Alberta Health services
- Study start
- Nov 2015
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 3 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: specialized breathalyzer w face recognition technologyIntervention is pregnant women enrolled and using specialized breathalyzer device w face recognition technology linked to a cellphone |
| Control Group | No intervention | –No intervention. No breathalyzer given. Access granted by participant to IHE to collect data from Alberta Health Services (medical records) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant, Alcoholic, actively in treatment for alcoholism addiction
Key exclusion criteria (1 listed)
- Not pregnant, not in treatment/therapy for addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| specialized breathalyzer w face recognition technologyAlso: Soberlink | Device | Experimental |
Primary outcome
Change in FASD Birthrate Levels
Time frame: 3 years
Binary- yes or no dx FASD within 3 years of birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andy Greenshaw, PhD principal investigator
Department of Psychiatry, University of Alberta
Egon Jonsson, PhD study director
Institute of Health Economics Executive Director and CEO
Questions about this trial
What is this clinical trial studying?
A study testing specialized breathalyzer w face recognition technology in people with Alcoholism and Pregnancy, run by Institute of Health Economics, Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FASD Birthrate Levels (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.