Assessment | Outcome measure | Respondent | Trial entry – Baseline | Follow-ups | ||||
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Week -2 (baseline 1) | Week -1 (Telephone contact) | Week 0 (baseline 2) | Week 4 | Week 12 | Month 6 | |||
Blood testing | Routine haematology | |||||||
FBC | Clinician |
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Serum folate | Clinician |
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Red Cell folate | Clinician |
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B12 | Clinician |
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Homocysteine | Clinician |
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Genetics | Clinician | (needs extra consent) | ||||||
Depression status | BDI | Patient |
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MADRS | Clinician/researcher |
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Health status and quality of life | CGI | Clinician/researcher |
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SF-12 | Patient |
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EQ-5D | Patient |
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Health economics | Resource usage | Patient |
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Compliance and side effects | Morisky Questionnaire | Patient |
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UKUside effects scale | Clinician/researcher |
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