Alcohol DrinkingNCT02642757
Alcohol Brief Counseling in Primary Care
A study testing AUDIT brief intervention and Pamphlet on alcohol use in people with Alcohol Drinking, run by Pontificia Universidad Catolica de Chile at 5 sites in Chile.
Trial summary
This study evaluates the effectiveness of a brief intervention for the reduction of alcohol use among risky alcohol users in primary care delivered by paramedics. Half of the participants will receive a brief intervention and half will receive written guidelines on safe alcohol use. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- AUDIT brief intervention and Pamphlet on alcohol use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 342 participants
- Where
- 5 sitesChile
- Study dates
- 15 Dec 2015to 30 Jul 2017
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- AUDIT score between 8 and 15
- Able to read
- Haven't received a similar intervention in the last 3 months
Who cannot join
- Clients in treatment for alcohol use disorder
- Alcohol use treatment seekers
- Pregnant woman
- Severe physical or psychiatric pathology not stable
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Chile5 sites
CESFAM San Alberto Hurtado
Santiago, Puente Alto, 8181297
CESFAM Madre Teresa de Calcuta
Santiago, Puente Alto
CESFAM Barros Luco
Santiago, San Miguel
CESFAM Recreo
Santiago, San Miguel
CESFAM Juan Pablo II
Santiago, Santiago Metropolitan
About this study
Official title: Effectiveness of a Brief Intervention for Reducing the Alcohol Use in Risky Users Delivered by Paramedics in Primary Care
This study evaluates the effectiveness of a brief intervention for the reduction of alcohol use among risky alcohol users in primary care delivered by paramedics. Half of the participants will receive a brief intervention and half will receive written guidelines on safe alcohol use.
Read the detailed description
Randomized controlled trial with a pragmatic emphasis undertaken in real world primary care.
The brief intervention has been designed and piloted by the mental health team at the Chilean ministry of health, as also the written support material. This intervention is the same that is being implemented national wide.
The implementation will include training of the paramedics, and then an accreditation session with a simulated participant in a double sided mirror.
Randomization will take place on site using a opaque envelope. The sequence will be keep on site in a secured box.
Data will be registered by the same person delivering the intervention and kept safe at the clinical sites. Once a month the data will be physically transferred to the operational center at the San Joaquin site of the Catholic University of Chile.
Bimonthly visits will be performed to the centers by a member of the team to assure that the protocol is being followed and data audit.
The participants will receive an economical incentive for the follow up visit. Participants will be reached throw telephone at least twice to schedule that visit. If not possible, a telephonic outcome assessment or a domiciliary visit will be performed to minimize the lost in follow up.
- Conditions
- Alcohol Drinking
- Being tested
- AUDIT brief intervention, Pamphlet on alcohol use
- Keywords
- alcohol drinking, hazardous alcohol use, risky alcohol consumption, heavy alcohol consumption
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUDIT brief interventionBehavioural
Intervention will be provided following the Chilean ministry of health implementation manual on the AUDIT associated brief intervention. The pamphlet on alcohol use will be provided to participants.
Pamphlet on alcohol useOther
Only the pamphlet on alcohol use will be provided (the same received by participants on the intervention group). This is not an active intervention based on the current literature.
| Study group | Role | What they receive |
|---|---|---|
| Brief intervention | Experimental | AUDIT brief intervention Receives: Behavioral: AUDIT brief intervention; Other: Pamphlet on alcohol use |
| Control group | Sham comparator | Pamphlet on alcohol use Receives: Other: Pamphlet on alcohol use |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUDIT score
Total of questions 1 to 10 (minimum 0, maximum 40)
Measured: 6 months post brief intervention
Secondary outcomes (1)
AUDIT-C score
Total of questions 1 to 3 (minimum 0, maximum 12)
Measured: 6 months post brief intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study start15 Dec 2015
- Primary completion30 Jul 2017
- Study completion30 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Barticevic, MD, Principal investigator, Instructor Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642757
- Sponsor's protocol ID
- 14-214
- Other IDs
- SM14I0033
- Status last verified
- May 2019
- First submitted
- 28 Dec 2015
- Last updated
- 22 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Barticevic NA, Poblete F, Zuzulich SM, Rodriguez V, Quevedo D, Sena BF, Bradshaw L. A Health Technician-delivered Brief Intervention linked to AUDIT for reduction of alcohol use in Chilean primary care: a randomized controlled trial. Addict Sci Clin Pract. 2021 Jun 15;16(1):39. doi: 10.1186/s13722-021-00248-4.
PubMed 34130748
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Brief Intervention for Reducing the Alcohol Use in Risky Users Delivered by Paramedics in Primary Care
- ClinicalTrials.gov ID
- NCT02642757
- Acronym / sponsor ID
- 14-214
- Conditions
- Alcohol Drinking
- Keywords
- alcohol drinking, hazardous alcohol use, risky alcohol consumption, heavy alcohol consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 15 Dec 2015
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 30 Dec 2015 (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.
This study evaluates the effectiveness of a brief intervention for the reduction of alcohol use among risky alcohol users in primary care delivered by paramedics. Half of the participants will receive a brief intervention and half will receive written guidelines on safe alcohol use.
Detailed description
Randomized controlled trial with a pragmatic emphasis undertaken in real world primary care.
The brief intervention has been designed and piloted by the mental health team at the Chilean ministry of health, as also the written support material. This intervention is the same that is being implemented national wide.
The implementation will include training of the paramedics, and then an accreditation session with a simulated participant in a double sided mirror.
Randomization will take place on site using a opaque envelope. The sequence will be keep on site in a secured box.
Data will be registered by the same person delivering the intervention and kept safe at the clinical sites. Once a month the data will be physically transferred to the operational center at the San Joaquin site of the Catholic University of Chile.
Bimonthly visits will be performed to the centers by a member of the team to assure that the protocol is being followed and data audit.
The participants will receive an economical incentive for the follow up visit. Participants will be reached throw telephone at least twice to schedule that visit. If not possible, a telephonic outcome assessment or a domiciliary visit will be performed to minimize the lost in follow up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief intervention | Experimental | Behavioral: AUDIT brief intervention, Other: Pamphlet on alcohol useAUDIT brief intervention |
| Control group | Sham comparator | Other: Pamphlet on alcohol usePamphlet on alcohol use |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- AUDIT score between 8 and 15
- Able to read
- Haven't received a similar intervention in the last 3 months
Key exclusion criteria (4 listed)
- Clients in treatment for alcohol use disorder
- Alcohol use treatment seekers
- Pregnant woman
- Severe physical or psychiatric pathology not stable
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 |
|---|---|---|
| AUDIT brief interventionIntervention will be provided following the Chilean ministry of health implementation manual on the AUDIT associated brief intervention. The pamphlet on alcohol use will be provided to participants. | Behavioural | Brief intervention |
| Pamphlet on alcohol useOnly the pamphlet on alcohol use will be provided (the same received by participants on the intervention group). This is not an active intervention based on the current literature. | Other | Brief intervention, Control group |
Primary outcome
AUDIT score
Time frame: 6 months post brief intervention
Total of questions 1 to 10 (minimum 0, maximum 40)
1 secondary outcome
AUDIT-C score
Time frame: 6 months post brief intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
- Derived from this study: PubMed 34130748Barticevic NA, Poblete F, Zuzulich SM, Rodriguez V, Quevedo D, Sena BF, Bradshaw L. A Health Technician-delivered Brief Intervention linked to AUDIT for reduction of alcohol use in Chilean primary care: a randomized controlled trial. Addict Sci Clin Pract. 2021 Jun 15;16(1):39. doi: 10.1186/s13722-021-00248-4.
- Individual participant dataSharing planned: No
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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.
Nicolas Barticevic, MD principal investigator
Instructor Professor
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AUDIT brief intervention and Pamphlet on alcohol use in people with Alcohol Drinking, run by Pontificia Universidad Catolica de Chile at 5 sites in Chile.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AUDIT score (time frame: 6 months post brief intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02642757, which also lists 1 linked publication.
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 22 May 2019.