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Randomization of PHCCs will be done once the caregivers eligible for the study have been chosen, so that recruitment by health professionals is not influenced by their allocation to a study group [ 28, 29].
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Concealment of group allocation will be achieved by giving the responsibility for allocation sequence generation and group allocation to a researcher independent of the study and its investigators.
If a patient agreed to participate in the study, allocation to a group was made by a second independent researcher, unaware of group codes.
Which tutorial an individual subject saw was dependent on the diagnosis of the index patient and on the randomized allocation to study condition.. Allocation to study condition was concealed from the participants until they began the tutorial.
Patients will have baseline measurements recorded before allocation to their study group.
Method of allocation to the study arms described and whether adequate/inadequate.
Like in many studies of organizational change, random allocation to study arms is not feasible, which implies an increased risk for confounding.
Owing to the blinding to group allocation, a study nurse is responsible for the main contact with the participants.
The randomisation is administered by an independent body (the NHMRC Clinical Trials Centre's Randomisation Service), who are contacted by telephone for the allocation of each patient to a study arm.
Allocation to study groups depends on decisions of statutory health insurances and on patients' preferences, completely independent of the study.
Allocation to study group will be by cluster, using CUs.
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