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A cluster randomized controlled trial to investigate the effectiveness and cost-effectiveness of the Girls Active interventionist and Version No: 30/01/2015 v2Sponsor Name: The University of Leicester Sponsor
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How to fill out a cluster randomised controlled

01
To fill out a cluster randomised controlled trial form, follow these steps:
02
Determine the cluster: Identify the groups or clusters that will be randomised.
03
Randomisation: Randomly assign the clusters into different treatment groups. This can be done using computer-generated random numbers or randomisation tables.
04
Interventions: Decide on the interventions or treatments that will be applied to each cluster.
05
Data collection: Determine which data will be collected to evaluate the outcomes of the trial and how it will be measured.
06
Assigning participants: Determine how participants will be assigned within each cluster, ensuring that the allocation is random and unbiased.
07
Monitoring: Establish a system to monitor the implementation of interventions and data collection within each cluster.
08
Follow-up: Determine the duration of the trial and plan for follow-up assessments or data collection points.
09
Analysis: Decide on the statistical methods that will be used to analyze the data collected from the trial.
10
Reporting: Prepare a detailed report summarizing the trial methodology, results, and conclusions.

Who needs a cluster randomised controlled?

01
Cluster randomised controlled trials are useful for researchers and policymakers in various fields, including:
02
- Public health: Evaluating the effectiveness of population-level interventions, such as community health programs or disease prevention strategies.
03
- Education: Assessing the impact of interventions at the school or classroom level, such as educational interventions or curriculum changes.
04
- Social sciences: Studying the effects of interventions on groups or communities, such as interventions targeting social behaviors or public policies.
05
- Healthcare: Examining the outcomes of interventions implemented at the healthcare system level, such as quality improvement initiatives or new healthcare delivery models.
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A cluster randomised controlled trial is a type of clinical trial in which clusters of individuals, rather than individual participants, are randomly assigned to different interventions or control groups.
Researchers conducting clinical trials involving clusters of participants are required to file a cluster randomised controlled trial.
To fill out a cluster randomised controlled trial, researchers must follow the protocol outlined in the trial design, including assigning clusters to interventions, collecting data, and analyzing results.
The purpose of a cluster randomised controlled trial is to evaluate the effectiveness of interventions at the cluster level, rather than the individual level, which can help to account for potential confounding factors.
Information such as the study design, recruitment methods, intervention details, outcome measures, and statistical analysis plan must be reported on a cluster randomised controlled trial.
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