Alcohol Use DisorderSCALANCT03524599
Scale-up of Prevention and Management of Alcohol Use Disorders and Comorbid Depression in Latin America
A study testing Intervention municipality in people with Alcohol Use Disorder, run by Maastricht University at 1 site in Colombia.
Trial summary
A quasi-experimental study will compare primary health care-based prevention and management of alcohol use disorder, operationalized by heavy drinking, in three intervention cities from Colombia, Mexico and Peru with three comparator cities from the same countries. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Intervention municipality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 690 participants
- Where
- 1 siteColombia
- Study dates
- 12 Sep 2018to 30 Jun 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Any fully trained medical practitioner, nurse or practice assistant
- Non-temporary employment contract
- Working in the selected primary health care centre
- Involved in medical and/or preventive care
Who cannot join
- Not a fully trained medical practitioner, nurse or practice assistant
- Having a temporary employment contract
- Not working in the selected primary health care centre
- Not involved in medical and/or preventive care
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Health Services Unit Fray Bartolomé de las Casas
Bogotá, 10366
About this study
A quasi-experimental study will compare primary health care-based prevention and management of alcohol use disorder, operationalized by heavy drinking, in three intervention cities from Colombia, Mexico and Peru with three comparator cities from the same countries. In the implementation cities, primary health care units (PHCUs) will receive training embedded within ongoing supportive municipal action over an 18-month implementation period. In the comparator cities, practice as usual will continue at both municipal and PHCU levels. The primary outcome will be the proportion of consulting adult patients intervened with (screened and advice given to screen positives).
- Conditions
- Alcohol Use Disorder
- Being tested
- Intervention municipality
- Keywords
- Heavy drinking, Primary health care, Training, Community
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention municipalityOther
In intervention municipalities, primary health care centres and the providers working within them will receive training and a range of community support mechanisms.
| Study group | Role | What they receive |
|---|---|---|
| Intervention municipality | Experimental | In the intervention municipalities, primary health care providers will receive ongoing training and support in undertaking screening and brief advice for heavy drinking. They will also receive community-based five adoption mechanisms and five support systems. Receives: Other: Intervention municipality |
| Comparator municipality | No intervention | In the comparator municipalities, the primary health care providers will be given a summary card of screening and brief advice for heavy drinking, with no instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of consulting adult patients (aged 18+ years) intervened
The number of AUDIT-C positive patients that received oral advice or referral for advice to another provider in or outside the primary health care centre (PHCC), divided by the total number of adult consultations of the participating providers per provider and per PHCC
Measured: 18 months
Secondary outcomes (2)
Proportion of patients screened
The proportion of patients screened will be calculated as the number of completed screens divided by the total number of consultations of all adult patients per participating provider, and averaged per participating PHCC
Measured: 18 months
Proportion of patients advised
The proportion of patients advised will be calculated as the number of brief interventions delivered (received oral brief advice, and/or were referred to another provider in or outside the practice), divided by the total number of screen positives per participating provider and averaged per participating PHCC
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start12 Sep 2018
- Primary completion31 Dec 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 690 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle University, Technische Universität Dresden
- Responsible party
- Sponsor
- Investigators
- Peter Anderson, MD, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524599
- Sponsor's protocol ID
- UMFHMLCapH2020
- Acronym
- SCALA
- Status last verified
- Apr 2024
- First submitted
- 2 May 2018
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Solovei A, Jane-Llopis E, Mercken L, Bustamante I, Kokole D, Mejia-Trujillo J, Medina Aguilar PS, Natera Rey G, O'Donnell A, Piazza M, Schmidt CS, Anderson P, de Vries H. Effect of Community Support on the Implementation of Primary Health Care-Based Measurement of Alcohol Consumption. Prev Sci. 2022 Feb;23(2):224-236. doi: 10.1007/s11121-021-01329-1. Epub 2022 Jan 15.
PubMed 35032246Anderson P, Manthey J, Llopis EJ, Rey GN, Bustamante IV, Piazza M, Aguilar PSM, Mejia-Trujillo J, Perez-Gomez A, Rowlands G, Lopez-Pelayo H, Mercken L, Kokole D, O'Donnell A, Solovei A, Kaner E, Schulte B, de Vries H, Schmidt C, Gual A, Rehm J. Impact of Training and Municipal Support on Primary Health Care-Based Measurement of Alcohol Consumption in Three Latin American Countries: 5-Month Outcome Results of the Quasi-experimental Randomized SCALA Trial. J Gen Intern Med. 2021 Sep;36(9):2663-2671. doi: 10.1007/s11606-020-06503-9. Epub 2021 Jan 19.
PubMed 33469752
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scale-up of Prevention and Management of Alcohol Use Disorders and Comorbid Depression in Latin America
- ClinicalTrials.gov ID
- NCT03524599
- Acronym / sponsor ID
- SCALA / UMFHMLCapH2020
- Conditions
- Alcohol Use Disorder
- Keywords
- Heavy drinking, Primary health care, Training, Community
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 690 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- Newcastle University, Technische Universität Dresden
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 15 May 2018 (actual)
- 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.
A quasi-experimental study will compare primary health care-based prevention and management of alcohol use disorder, operationalized by heavy drinking, in three intervention cities from Colombia, Mexico and Peru with three comparator cities from the same countries. In the implementation cities, primary health care units (PHCUs) will receive training embedded within ongoing supportive municipal action over an 18-month implementation period. In the comparator cities, practice as usual will continue at both municipal and PHCU levels. The primary outcome will be the proportion of consulting adult patients intervened with (screened and advice given to screen positives).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention municipality | Experimental | Other: Intervention municipalityIn the intervention municipalities, primary health care providers will receive ongoing training and support in undertaking screening and brief advice for heavy drinking. They will also receive community-based five adoption mechanisms and five support systems. |
| Comparator municipality | No intervention | –In the comparator municipalities, the primary health care providers will be given a summary card of screening and brief advice for heavy drinking, with no instruction |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Any fully trained medical practitioner, nurse or practice assistant
- Non-temporary employment contract
- Working in the selected primary health care centre
- Involved in medical and/or preventive care
Key exclusion criteria (4 listed)
- Not a fully trained medical practitioner, nurse or practice assistant
- Having a temporary employment contract
- Not working in the selected primary health care centre
- Not involved in medical and/or preventive care
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 |
|---|---|---|
| Intervention municipalityIn intervention municipalities, primary health care centres and the providers working within them will receive training and a range of community support mechanisms. | Other | Intervention municipality |
Primary outcome
Proportion of consulting adult patients (aged 18+ years) intervened
Time frame: 18 months
The number of AUDIT-C positive patients that received oral advice or referral for advice to another provider in or outside the primary health care centre (PHCC), divided by the total number of adult consultations of the participating providers per provider and per PHCC
2 secondary outcomes
Proportion of patients screened
Time frame: 18 months
Proportion of patients advised
Time frame: 18 months
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 15 Apr 2024.
- Derived from this study: PubMed 35032246Solovei A, Jane-Llopis E, Mercken L, Bustamante I, Kokole D, Mejia-Trujillo J, Medina Aguilar PS, Natera Rey G, O'Donnell A, Piazza M, Schmidt CS, Anderson P, de Vries H. Effect of Community Support on the Implementation of Primary Health Care-Based Measurement of Alcohol Consumption. Prev Sci. 2022 Feb;23(2):224-236. doi: 10.1007/s11121-021-01329-1. Epub 2022 Jan 15.
- Derived from this study: PubMed 33469752Anderson P, Manthey J, Llopis EJ, Rey GN, Bustamante IV, Piazza M, Aguilar PSM, Mejia-Trujillo J, Perez-Gomez A, Rowlands G, Lopez-Pelayo H, Mercken L, Kokole D, O'Donnell A, Solovei A, Kaner E, Schulte B, de Vries H, Schmidt C, Gual A, Rehm J. Impact of Training and Municipal Support on Primary Health Care-Based Measurement of Alcohol Consumption in Three Latin American Countries: 5-Month Outcome Results of the Quasi-experimental Randomized SCALA Trial. J Gen Intern Med. 2021 Sep;36(9):2663-2671. doi: 10.1007/s11606-020-06503-9. Epub 2021 Jan 19.
- 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.
Peter Anderson, MD, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention municipality in people with Alcohol Use Disorder, run by Maastricht University at 1 site in Colombia.
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 4 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 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. 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. 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?
Proportion of consulting adult patients (aged 18+ years) intervened (time frame: 18 months). 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 NCT03524599, which also lists 2 linked publications.
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 15 Apr 2024.