Drowning Clinical Trial
Official title:
Improving Lifejacket Wear Among Boaters on Lake Albert, Uganda. A Cluster-randomized Trial
NCT number | NCT05337761 |
Other study ID # | SS992ES |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 25, 2022 |
Est. completion date | October 2022 |
A cluster randomized trial will be conducted for six months. To avoid covariate imbalance at baseline, stratified permuted block randomization with a 1:1 allocation ratio will be done. At least 387 boaters across 7 clusters per arm will be interviewed post baseline to give a 90% power to detect the effect of the intervention if such effect exists. A mixed effects multi-level modeling at 5% alpha level will be done using logical model building procedures
Status | Recruiting |
Enrollment | 387 |
Est. completion date | October 2022 |
Est. primary completion date | September 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - The landing sites (clusters) should not be flooded, should not be receiving any known educational/behavior related intervention except the routine marine police messages Exclusion Criteria: - Landing sites that are inaccessible because of the bad terrain and poor security |
Country | Name | City | State |
---|---|---|---|
Uganda | Makerere University School of Public Health | Kampala |
Lead Sponsor | Collaborator |
---|---|
Makerere University | Consortium for Advanced Research Training in Africa (CARTA) |
Uganda,
Bennett S, Woods T, Liyanage WM, Smith DL. A simplified general method for cluster-sample surveys of health in developing countries. World Health Stat Q. 1991;44(3):98-106. — View Citation
Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in prevalence of lifejacket wear among the boaters | The intention to treat analysis will be used to assess the change in prevalence of lifejacket wear among the boaters. Multilevel modeling (cluster level model and boater level model) with a focus on the individual as the unit of analysis while accounting for clustering will be conducted. The generalized estimating equation (GEE) will be used to account for within-cluster variations. The goodness of fit of the model will be tested using the Hosmer Lemeshow test. Comparison between the baseline and end-line will be done and the difference in differences (Diff in Diff) will be reported to show the change of effect in the intervention and control arm. | Six months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05977530 -
Teaching Young Children Swim Survival Skills
|
N/A | |
Recruiting |
NCT03498963 -
Pathogens Responsible for Respiratory Infections Associated With Drowning in Seawater
|
N/A | |
Completed |
NCT05908630 -
Accidental Hypothermia in Drowning-related OHCA
|
||
Not yet recruiting |
NCT06310486 -
The Emergency Call on Drowning
|
||
Not yet recruiting |
NCT06312202 -
Drowning Incidents in Danish Harbours
|
||
Not yet recruiting |
NCT06327893 -
Patients Treated by the Danish Emergency Medical Services Following Non-drowning Water Rescues From 2016 to 2023
|
||
Completed |
NCT00341289 -
Environmental and Behavioral Risk Factors for Childhood Drowning
|
N/A | |
Active, not recruiting |
NCT06322134 -
Drowning Incidents Treated by the Danish SAR Helicopters
|
||
Completed |
NCT04250532 -
Pulse Oximetry in Healthy SubjEcts ImmergeD in OceaN.
|
||
Completed |
NCT05751655 -
Observational Study of Drowning Patient's Emergency Care in Its Pre-hospital Phase.
|
||
Not yet recruiting |
NCT06334276 -
Developing an Utstein-style Danish Drowning Registry: Nationwide Fatal and Nonfatal Drowning Data Since 2016
|
||
Active, not recruiting |
NCT06310525 -
Using Machine Learning to Optimise the Danish Drowning Formula
|
||
Recruiting |
NCT06320197 -
In Situ Simulation Training in Lifeguard Organisations
|
||
Completed |
NCT05323097 -
Drowning-related OHCA in Denmark: A Six-year Registry-based Study
|
||
Completed |
NCT05425537 -
Drowning in Denmark: A Six-year Registry-based Study of Fatal and Non-fatal Drowning
|
||
Not yet recruiting |
NCT06310499 -
Primary or Secondary Drowning
|
||
Not yet recruiting |
NCT06183827 -
Drowning-related Acute Respiratory Failure
|
N/A |