Table 2:
STURDY Data Collection Schedule.
| Months from randomization | Pre-RZ | RZ | Year 1 | Year 2 | |||||||||
| −2+ | -2 | −1 | 0 | 1 | 3 | 6 | 9 | 12 | 15 | 18 | 21 | 24 | |
| [C]linic, [T]elephone, or [E]ither |
E | C | C | C | T | C | T | T | C | T | T | T | C |
| Visit | PS | SV+ | BV+ | RZ | F01 | F03 | F06 | F09 | F12 | F15 | F18 | F21 | F24 |
| Consent | O | W | W | O | • | • | • | • | • | • | • | • | • |
| Prescreen questionnaire | X | • | • | • | • | • | • | • | • | • | • | • | • |
| Registration (demographics, eligibility questions) |
• | X | • | • | • | • | • | • | • | • | • | • | • |
| Blood draw* | • | X | X | • | • | X | • | • | X | • | • | • | X |
| Urine collection (stored) | • | • | X | • | • | X | • | • | X | • | • | • | X |
| Medical history, incl. adverse events |
• | X | X | X | X | X | X | X | X | X | X | X | X |
| Cognitive testing$ | • | X | • | • | • | X | • | • | X | • | • | • | X |
| Physical measurements# | • | • | X | • | • | X | • | • | X | • | • | • | X |
| Short Physical Performance Battery (SPPB) |
• | • | X | • | • | X | • | • | X | • | • | • | X |
| Timed Up and Go (TUG) Test |
• | • | X | • | • | X | • | • | X | • | • | • | X |
| Accelerometry | • | • | X | • | • | X | • | • | X | • | • | • | X |
| 6-minute walk | • | • | X | • | • | X | • | • | X | • | • | • | X |
| Grip strength | • | • | X | • | • | X | • | • | X | • | • | • | X |
| Physical function questionnaire+ |
• | • | X | • | • | X | • | • | X | • | • | • | X |
| Physical activity questionnaire+ |
• | • | X | • | • | X | • | • | X | • | • | • | X |
| Vitamin D and calcium food frequency questionnaire+ |
• | • | X | • | • | • | • | • | • | • | • | • | • |
| SF-12 health survey+ | • | • | X | • | • | X | • | • | • | • | • | • | • |
| Adherence reminders | • | • | X | X | X | X | X | X | X | X | X | X | X |
| Fall calendar | • | • | RI^ | X | X | X | X | X | X | X | X | X | X |
| Pill distribution/return | • | • | RI^ | X | • | M | M | M | X | M | M | M | X |
Abbreviations: RZ=Randomization Visit; PS=Pre-screening; SV=Screening Visit; BV=Baseline Visit; Fxx=Follow-up visit; O=oral; W=written; RI=run-in; M=by mail;
+
physical assessments and questionnaires can be completed at either SV or BV, as long as they are completed prior to RZ
*
real-time 25(OH)D and calcium; stored blood
$
MMSE at screening visit; Mini-Cog® at follow-up visits
#
height (baseline only), weight, blood pressure, including orthostatic blood pressure, and heart rate
^
at the end of BV, the participant will be given placebo pills and instructed to take one daily and complete the pill/fall calendar for a period of about 10 days, which the participant will return at RZ