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In the IG, an additional assessment will be given immediately after the intervention has been completed.
To determine the sustainability of the quality of care provided an additional assessment will be undertaken at 12-15 months later to determine the extent to which the quality of care has changed.
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Additional assessments will be performed at 24 and 36 months.
Due to restrictions on the use of the tests used for measurements of cognitive performance, these additional assessments will be carried out by a member of the research team (SK), a licensed clinical psychologist, and studied in a smaller subsample.
17 Additional assessments will be needed as a basis for proposing that mHealth approaches be implemented at scale. 4 Based on the results of this validation study, we recommend that Malawi conduct periodic mobile telephone interviews with front-line health workers as one component of their strategy for monitoring and evaluating the CCM program.
An additional Qol assessment will be conducted if notable changes in the residents' needs are perceived.
For the Waitlist group, an additional baseline assessment will be conducted at 20 weeks postrandomisation (T2), and then postintervention at 20 weeks after commencing the Mitii training (40 weeks postrandomisation, T3).
An additional 100 ml blood per assessment will be drawn for the translational program in weeks 9, 26, 50, and 98 in order to evaluate the immune responses (cellular/humoral) to the vaccine/placebo.
The assessment will be completed by March 2015.
Exposure assessment will be challenging.
Outcome assessment will be blinded as above.
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