Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12616001250426 |
Date of registration:
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07/09/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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MOZambique snApshot of emeRging Trends (MOZART) Disease Surveillance Study
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Scientific title:
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MOZambique snApshot of emeRging Trends (MOZART) Disease Surveillance Study of Communicable versus Non-Communicable Diseases and Injuries in Urban Referral Hospitals of Mozambique |
Date of first enrolment:
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04/04/2016 |
Target sample size:
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7000 |
Recruitment status: |
Recruiting |
URL:
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https://anzctr.org.au/ACTRN12616001250426.aspx |
Study type:
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Observational |
Study design:
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Purpose: Natural history;Duration: Cross-sectional;Selection: Random sample;Timing: Prospective;
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Phase:
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Not Applicable
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Countries of recruitment
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Mozambique
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Contacts
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Name:
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Ms Ashley K Keates
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Address:
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Mary MacKillop Institute for Health Research
Australian Catholic University
215 Spring Street
Melbourne VIC
3000
Australia |
Telephone:
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+61 477 166 859 |
Email:
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Kimberley.Keates@acu.edu.au |
Affiliation:
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Name:
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Prof Simon Stewart
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Address:
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Mary MacKillop Institute for Health Research
Australian Catholic University
215 Spring Street
Melbourne VIC
3000
Australia |
Telephone:
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+61 438 302 111 |
Email:
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Simon.Stewart@acu.edu.au |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: During each study period (initially four sets of 30-day snap=shot periods followed by a repeat snap-shot in the opposite season), all patients (i.e. 24 hours a day) presenting to the emergency department of the participating hospitals will be recorded and cases randomly selected for more detailed clinical profiling. All selected patients, regardless of age, will be included in the screening process.
Exclusion criteria: Patients will be excluded from the study if they are unable to respond to the trained nurses or the study survey team (i.e., unconscious, confused due to mental illness, severely ill, or under the influence of illicit drugs) unless the study team is able to obtain data from a family member/partner.
Age minimum:
No limit
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Public Health - Epidemiology
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Communicable and Non-Communicable Diseases; Communicable and Non-Communicable Diseases
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Intervention(s)
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The MOZART Disease Surveillance Study is a prospective, multi-centred study with random profiling of representative case presentations at three tertiary hospitals in Mozambique (Hospital Geral de Mavalane, Hospital Central da Beira and Hospital Central de Nampula). For each participating hospital, electronic surveys will be conducted face-to-face for 30 consecutive days at a time (primary outcome data). A minimum target of 1000 participants will determine the ratio/proportion of all cases selected for more detailed profiling at each site. Accordingly all emergency presentations during the study period will be monitored via the point of entry to the hospital's emergency department with basic information recorded to determine the overall case-load of emergency presentations during the 30-day snap-shot period. Based on their order of presentation (selection of every fifth or sixth case), participants will be approached by MOZART personnel , and if informed consent is provided, subject to more detailed clinical following (including hospital outcome). The 30-day snapshots will be replicated at all three sites to capture seasonal changes in profile between the wet and dry seasons (secondary outcome data). As noted, all patients presenting to the Emergency Departments during the study period will be eligible for screening and those recruited by trained health professionals will be followed from point-of-admission up until discharge. Two Microsoft Access Questionnaire Databases were conceived jointly by Instituto Nacional de Saude (INS), Mozambique and the Mary MacKillop Institute for Health Research (MMIHR), Australian Catholic University, Australia. A final version was built in Portuguese at MMIHR where the Patients Registration profile (name, residential suburb, contact det
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Primary Outcome(s)
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The primary outcome of the MOZART study is to determine the balance between CDs and NCDs in three major hospitals in Mozambique. We will collect data from a minimum of 3,500 patients during the initial and follow-up 30-day snapshot periods for the three participating hospitals (minimum of 7000 patients during the combined “wet” and “dry” season snapshots) - by completing electronic surveys using Microsoft Access and then following up patients' discharge details from the hospital records.[Patients will be followed from point-of-admission up until discharge over the initial 30-day snapshot/observation period for each participating hospital (to be completed between April 2016 and December 2017).]
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Secondary Outcome(s)
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The secondary outcome for the MOZART study is to compare the balance between CDs and NCDs in three major hospitals in Mozambique during the "wet" and "dry" season by completing a second observational survey in the opposite season to the first. To match data from the initial surveys, we will collect data from a minimum of 3,500 patients during the second 30-day snapshot period for the three participating hospitals - by completing electronic surveys using Microsoft Access and then following up patients' discharge details from the hospital records.[Patients will be followed from point-of-admission up until discharge over two 30-day snapshot/observation periods for each participating hospital conducted in two different seasons (wet and dry) between April 2016 and December 2018.
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Source(s) of Monetary Support
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Instituto Nacional de Saude
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Mary MacKillop Institute for Health Research Centre for Research Excellence, Australian Catholic University
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Ethics review
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Status: Approved
Approval date:
Contact:
Mozambican National Bioethical Committee/Ministerio da Saude,
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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