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Scale-up of Prevention and Management of Alcohol Use Disorders and Comorbid Depression in Latin America (SCALA)

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ClinicalTrials.gov Identifier: NCT03524599
Recruitment Status : Not yet recruiting
First Posted : May 15, 2018
Last Update Posted : June 1, 2018
Sponsor:
Collaborators:
Newcastle University
Technische Universität Dresden
Information provided by (Responsible Party):
Maastricht University

Brief 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. 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).

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Other: Intervention municipality Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Scale-up of Prevention and Management of Alcohol Use Disorders and Comorbid Depression in Latin America
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: Intervention municipality
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.
Other: Intervention municipality
In intervention municipalities, primary health care centres and the providers working within them will receive training and a range of community support mechanisms.

No Intervention: Comparator municipality
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Proportion of patients screened [ Time Frame: 18 months ]
    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

  2. Proportion of patients advised [ Time Frame: 18 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT03524599


Contacts
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Contact: Peter Anderson, MD, PhD +34 618075217 peter.anderson@maastrichtuniversity.nl

Sponsors and Collaborators
Maastricht University
Newcastle University
Technische Universität Dresden
Investigators
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Principal Investigator: Peter Anderson, MD, PhD Professor

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Responsible Party: Maastricht University
ClinicalTrials.gov Identifier: NCT03524599     History of Changes
Other Study ID Numbers: UMFHMLCapH2020
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht University:
Heavy drinking
Primary health care
Training
Community
Additional relevant MeSH terms:
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Disease
Alcoholism
Depression
Alcohol Drinking
Pathologic Processes
Behavioral Symptoms
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders