DrowningNCT05337761
Improving Lifejacket Wear Among Boaters on Lake Albert, Uganda
A study testing Peer-led training on lifejacket wear in people with Drowning, run by Makerere University at 1 site in Uganda.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drowning
- What is being tested?
- Peer-led training on lifejacket wear
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 387 participants
- Where
- 1 siteUganda
- Study dates
- 25 Apr 2022to Oct 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The landing sites (clusters) should not be flooded, should not be receiving any known educational/behavior related intervention except the routine marine police messages
Who cannot join
- Landing sites that are inaccessible because of the bad terrain and poor security
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Makerere University School of Public Health
Kampala, P.O.Box:7072
Frederick Oporia, 0703857428, foporia@musph.ac.ug
About this study
Official title: Improving Lifejacket Wear Among Boaters on Lake Albert, Uganda. A Cluster-randomized Trial
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
Read the detailed description
Given that the intervention will be at the community level, a cluster randomized controlled trial is considered most appropriate for testing the hypothesis of this study. The intact groups/clusters of individuals (boaters) rather than individuals themselves, will be randomized to either intervention or control arm. The landing sites herein referred to as clusters, will be the randomization unit. This is because it is difficult to randomize individuals to behavioral intervention since they mix within the cluster. This study will be conducted using an etic epistemological approach guided by a realist ontology in order to objectively measure the effect of the intervention without the influence of the researchers.
To reduce covariate imbalance and increase comparability at baseline, clusters will be randomized to either intervention or control arm using stratified permuted block randomization, with landing sites (clusters) as the randomization unit. The clusters will be stratified by estimated population size and baseline prevalence of lifejacket use as compared with the overall average prevalence. All individuals in the intervention cluster will receive the intervention. The main aim of the stratified randomization is to ensure that the clusters are as comparable as possible at baseline. The other factors that might be considered for stratification will be identified at baseline and, in the opinion of the investigator, might interfere with the objectives of the study. Because there are few clusters per arm (7), two strata will be formed. The stratification variable will be the baseline prevalence of lifejacket wear in the landing sites.
The risk of contamination (one of the major threats to this study) will be reduced by ensuring that at least one cluster which is not part of the study acts as a buffer. From each stratum, one cluster will be randomly allocated to the intervention arm and the other to the control arm using stratified permuted block randomization with a 1:1 allocation ratio. The allocation will be generated using the 'sealed envelope TM' web-based application by an independent statistician who has no interest in the study. The block sizes will be masked/blinded to increase the randomness.
- Conditions
- Drowning
- Being tested
- Peer-led training on lifejacket wear
- Keywords
- Drowning prevention, Occupational boating, Uganda
- Medical subject headings
- Drowning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-led training on lifejacket wearBehavioural
Training on proper lifejacket wear will be given to peers who will be the change agents amongst their fellow boaters
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The peers will be trained to train their colleagues (fellow boaters) on proper lifejacket use. A training manual has been developed for this. Receives: Behavioral: Peer-led training on lifejacket wear |
| Control | Placebo comparator | The Marine Police will be encouraged to continue conducting their community policing on water safety and emphasize lifejacket wear. Receives: Behavioral: Peer-led training on lifejacket wear |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start25 Apr 2022
- Primary completionSep 2022 (estimated)
- Study completionOct 2022 (estimated)
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 DrowningStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 387 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- Consortium for Advanced Research Training in Africa (CARTA)
- Responsible party
- Sponsor
- Investigators
- Frederick Oporia, MPH, Principal investigator, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337761
- Sponsor's protocol ID
- SS992ES
- Status last verified
- May 2022
- First submitted
- 4 Apr 2022
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with the PhD supervisory team
Publications
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.
PubMed 1949887Michie 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.
PubMed 21513547
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Lifejacket Wear Among Boaters on Lake Albert, Uganda. A Cluster-randomized Trial
- ClinicalTrials.gov ID
- NCT05337761
- Acronym / sponsor ID
- SS992ES
- Conditions
- Drowning
- Keywords
- Drowning prevention, Occupational boating, Uganda
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 387 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- Consortium for Advanced Research Training in Africa (CARTA)
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 20 Apr 2022 (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 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
Detailed description
Given that the intervention will be at the community level, a cluster randomized controlled trial is considered most appropriate for testing the hypothesis of this study. The intact groups/clusters of individuals (boaters) rather than individuals themselves, will be randomized to either intervention or control arm. The landing sites herein referred to as clusters, will be the randomization unit. This is because it is difficult to randomize individuals to behavioral intervention since they mix within the cluster. This study will be conducted using an etic epistemological approach guided by a realist ontology in order to objectively measure the effect of the intervention without the influence of the researchers.
To reduce covariate imbalance and increase comparability at baseline, clusters will be randomized to either intervention or control arm using stratified permuted block randomization, with landing sites (clusters) as the randomization unit. The clusters will be stratified by estimated population size and baseline prevalence of lifejacket use as compared with the overall average prevalence. All individuals in the intervention cluster will receive the intervention. The main aim of the stratified randomization is to ensure that the clusters are as comparable as possible at baseline. The other factors that might be considered for stratification will be identified at baseline and, in the opinion of the investigator, might interfere with the objectives of the study. Because there are few clusters per arm (7), two strata will be formed. The stratification variable will be the baseline prevalence of lifejacket wear in the landing sites.
The risk of contamination (one of the major threats to this study) will be reduced by ensuring that at least one cluster which is not part of the study acts as a buffer. From each stratum, one cluster will be randomly allocated to the intervention arm and the other to the control arm using stratified permuted block randomization with a 1:1 allocation ratio. The allocation will be generated using the 'sealed envelope TM' web-based application by an independent statistician who has no interest in the study. The block sizes will be masked/blinded to increase the randomness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Peer-led training on lifejacket wearThe peers will be trained to train their colleagues (fellow boaters) on proper lifejacket use. A training manual has been developed for this. |
| Control | Placebo comparator | Behavioral: Peer-led training on lifejacket wearThe Marine Police will be encouraged to continue conducting their community policing on water safety and emphasize lifejacket wear. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The landing sites (clusters) should not be flooded, should not be receiving any known educational/behavior related intervention except the routine marine police messages
Key exclusion criteria (1 listed)
- Landing sites that are inaccessible because of the bad terrain and poor security
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 |
|---|---|---|
| Peer-led training on lifejacket wearTraining on proper lifejacket wear will be given to peers who will be the change agents amongst their fellow boaters | Behavioural | Control, Intervention |
Primary outcome
Change in prevalence of lifejacket wear among the boaters
Time frame: Six months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Results publication: PubMed 1949887Bennett 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.
- Results publication: PubMed 21513547Michie 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.
- Individual participant dataSharing planned: Yes. Data will be shared with the PhD supervisory team
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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.
Frederick Oporia, MPH principal investigator
Makerere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-led training on lifejacket wear in people with Drowning, run by Makerere University at 1 site in Uganda.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 May 2022. 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 Uganda. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frederick Oporia, MPH (+256703857428, foporia@musph.ac.ug), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in prevalence of lifejacket wear among the boaters (time frame: Six 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 NCT05337761, 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 17 May 2022.