Med notes review/check | Pre- baseline phone call | Baseline interview | Nurse baseline | 6 month medical/ nurse follow-up | 6 month follow-up interview | Med notes follow-up | |
---|---|---|---|---|---|---|---|
Eligibility and consent | |||||||
Presence and role of a supporter and/or research advocate | X | X | |||||
Mental capacity to consent to Phase II (P, R) | X | ||||||
Eligibility for Phase II (assessed by Study Researcher) | X | X | X | ||||
Consent for Phase II (P, S, Ra) | X | ||||||
Follow-up data (P, S, R, N) | |||||||
Negative outcomes | X | ||||||
Related and Unexpected Serious Adverse Events | X | ||||||
Hospital attendances | X | ||||||
Current physical health state (for example, HbA1c, BP, BMI, weight, BP, HbA1C, cholesterol, HDL/ LDL triglycerides, Urea and Electrolytes, waist to hip ratio (N) | X | X | X | ||||
Thyroid function, height (N) | X | ||||||
Q Risk, Retinal screening, Medication, Serum creatinine, micro-albuminuria | X | ||||||
Details of Treatment Received | X | ||||||
Adherence to the intervention (N) | X | ||||||
Prescribed diabetes regime (diet, exercise) | X | ||||||
Questionnaires (completed at Researcher visit) | |||||||
Health Economics questionnaire (P and S interviewer administered) to cover health and social care costs, participant and supporter expenses and productivity costs | X | X | |||||
Participant (P) mood (questions taken from Phase I) | X | X | |||||
Health-related quality of life (EQ5D) (P) | X | X |