Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001250426
Ethics application status
Approved
Date submitted
2/09/2016
Date registered
7/09/2016
Date last updated
17/10/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
MOZambique snApshot of emeRging Trends (MOZART) Disease Surveillance Study
Scientific title
MOZambique snApshot of emeRging Trends (MOZART) Disease Surveillance Study of Communicable versus Non-Communicable Diseases and Injuries in Urban Referral Hospitals of Mozambique
Secondary ID [1] 290075 0
None
Universal Trial Number (UTN)
U1111-1187-1550
Trial acronym
MOZART
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Communicable and Non-Communicable Diseases 300152 0
Condition category
Condition code
Public Health 300029 300029 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
7
Target follow-up type
Days
Description of intervention(s) / exposure
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 details and hospital identification) are collected at the participating hospitals on dedicated study laptops and then stored with the INS to ensure the privacy of each patient. Health data (basic demographics, risk profile, medical history, admission details, and treatment) for each patient are then anonymously recorded on an external database and then transferred to, analysed, recorded, and stored by Data Management at the MMIHR. The methodologically and systematically closed- and open-questions in the electronic database provides efficient means of data entry, storage, and management.
Intervention code [1] 295808 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299512 0
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.
Timepoint [1] 299512 0
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).
Secondary outcome [1] 327373 0
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.
Timepoint [1] 327373 0
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.

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
The study will be undertaken and reported according to STROBE guidelines for observational studies. As the eligible population for screening includes every patient presenting at the emergency department over a 30-day period (varying from 4,000-6,000 patients per month depending on the hospital), a systematic selection process of consecutive cases (according to arrival sequence) will be applied to achieve a minimum target of 1,000 patients per snapshot period. Based on recruitment during the first phase of screening (completed in April 2017) a target of 7000 participants has been established.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/04/2016
Date of last participant enrolment
Anticipated
30/11/2017
Actual
Date of last data collection
Anticipated
30/12/2017
Actual
Sample size
Target
7000
Accrual to date
3644
Final
Recruitment outside Australia
Country [1] 8176 0
Mozambique
State/province [1] 8176 0
Maputo City
Country [2] 8178 0
Mozambique
State/province [2] 8178 0
Nampula
Country [3] 8179 0
Mozambique
State/province [3] 8179 0
Sofala

Funding & Sponsors
Funding source category [1] 294444 0
Other
Name [1] 294444 0
Instituto Nacional de Saude
Country [1] 294444 0
Mozambique
Funding source category [2] 294445 0
Other Collaborative groups
Name [2] 294445 0
Mary MacKillop Institute for Health Research Centre for Research Excellence, Australian Catholic University
Country [2] 294445 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Mary MacKillop Institute for Health Research Centre for Research Excellence, Australian Catholic University
Address
215 Spring Street
Melbourne VIC
3000
Country
Australia
Secondary sponsor category [1] 293299 0
Other
Name [1] 293299 0
Instituto Nacional de Saude
Address [1] 293299 0
Av. Eduardo Mondlane/Salvador Allende
Caixa Postal 264
Maputo – Mozambique
Country [1] 293299 0
Mozambique

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295875 0
Mozambican National Bioethical Committee/Ministerio da Saude,
Ethics committee address [1] 295875 0
Instituto Nacional de Saude & Universidade Eduardo Mondlane
Avenida Eduardo Mondlane, 1008
Maputo, Mozambique
Ethics committee country [1] 295875 0
Mozambique
Date submitted for ethics approval [1] 295875 0
11/01/2016
Approval date [1] 295875 0
12/02/2016
Ethics approval number [1] 295875 0

Summary
Brief summary
Both Communicable diseases (CDs) and Non-Communicable diseases (NCDs) are a growing public health concern worldwide. However, there is limited data describing the epidemiological balance between CDs and NCDs in developing countries. In sub-Saharan Africa, NCDs are responsible for a third of the disability-adjusted life year burden, and are becoming critical health issues. Mozambique, where the population is expected to double by 2030 and life expectancy is increasing will be a key barometer of epidemiological transition in the region. Our primary aim is to examine and describe the current and likely epidemiological balance between CDs and NCDs within the Mozambique population.
The MOZambique snApshot of emeRging Trends (MOZART) Disease Surveillance Study is a prospective, multi-centre study with random profiling of one-in-five representative case presentations at four tertiary hospitals in Mozambique. For each participating hospital, surveys will be conducted for 30 consecutive days at a time and then replicated in a different season, to capture seasonal changes in profile between the wet and dry seasons. All patients presenting to the Emergency Departments during the study period will be eligible for screening and those recruited will be followed from point-of-admission up until discharge.
This unique study, to be undertaken in a low-resource setting will provide invaluable data in respect to the balance of CDs and NCDs in different regions of Mozambique, and at different times of the year. The initial pilot study confirmed both the feasibility (>1300 cases comprehensively profiled) and value of the study in this regard.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68774 0
Prof Ana Mocumbi
Address 68774 0
Instituto Nacional de Saude & Universidade Eduardo Mondlane
Avenida Eduardo Mondlane, 1008
Maputo, Mozambique
Country 68774 0
Mozambique
Phone 68774 0
+258 2143 1103 / +258 2131 1038
Fax 68774 0
Email 68774 0
[email protected]
Contact person for public queries
Name 68775 0
Ms Ashley K Keates
Address 68775 0
Mary MacKillop Institute for Health Research
Australian Catholic University
215 Spring Street
Melbourne VIC
3000
Country 68775 0
Australia
Phone 68775 0
+61 477 166 859
Fax 68775 0
Email 68775 0
[email protected]
Contact person for scientific queries
Name 68776 0
Prof Simon Stewart
Address 68776 0
Mary MacKillop Institute for Health Research
Australian Catholic University
215 Spring Street
Melbourne VIC
3000
Country 68776 0
Australia
Phone 68776 0
+61 438 302 111
Fax 68776 0
(+613) 9663 5726
Email 68776 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4029Plain language summaryNo METHODS: We undertook a pragmatic, prospective, ... [More Details]
4625Study results articleYes Mocumbi AO, Cebola B, Muloliwa A, Sebastião F, Sit... [More Details] 371429-(Uploaded-18-09-2019-21-32-40)-Journal results publication.pdf

Documents added automatically
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