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The dose delivered (intervention components), completeness of intervention components, and fidelity of implementation will be recorded by qualitative (site visits) and quantitative (logbooks, checklists) methods.
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The time spent by individuals involved in the implementation of HeLP-Diabetes will be recorded on a proforma.
Any amendments to the study protocol will be recorded and submitted to the MEC, with substantial amendments submitted for approval prior to implementation.
Both will be recorded.
Interventions will be recorded.
All readmissions will be recorded.
The latter will be recorded.
Dose changes will be recorded.
This reason will be recorded.
Clinical parameters will be recorded.
All interviews will be recorded.
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