Work Package 3 – Feasibility Cluster Randomised Control Trial (CRCT)
Led by Professor Fox

What is a Cluster Randomised Control Trial?

A Randomised Control Trial is a study where people with a similar condition are randomly assigned to two groups to test a specific intervention. One group (the experimental group) receives the intervention being tested, the other (the control group) has no intervention. The groups are followed up to see if the intervention has had an effect. In this trial, different GP practices will be randomly assigned to participate in either the intervention or control treatment. Hence, we will cluster the randomisation so that all patients from specific practices receive either the intervention or control treatment.

What’s our research question?

Is a Randomised Control Trial (RCT) of this intervention feasible?

How will we do this?

We will recruit 64 participants (32 intervention 32 control) over five months, across eight GP sites. Participants will either receive the TIMES intervention or receive treatment as usual (control). We will test whether recruitment and retention rates, in addition to other measures (i.e. questionnaires about sleep duration or quality of life), differ between the intervention and control groups.

Successful outcomes

Information gained from this feasibility study will allow us refine the TIMES intervention and improve the design of a full-scale trial.

TIMES programme is divided across the following work packages:

WORK PACKAGE 1a

Realist Review

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WORK PACKAGE 1b

Ethnography, focus groups & survey

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WORK PACKAGE 2

Co-design & implementation

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WORK PACKAGE 3

Feasibility cluster randomised control trial

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WORK PACKAGE 4

Cluster randomised control trial with internal pilot

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Research Partners