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Table 1 Study SPIRIT diagram

From: An observational study protocol to explore loneliness and systemic inflammation in an older adult population with chronic venous leg ulcers

TIMEPOINT

STUDY PERIOD

ENROLLMENT

VISIT SCHEDULE

Day 0

Week 4

Week 8

ENROLLMENT

 Eligibility screening checklist

X

  

 Informed consent

X

  

 Allocation (L+/L-)

X

  

ASSESSMENTS AND MEASURES

 Demographics and characteristics

X

  

 Wound assessment and medical health history

X

 X

 

VEINES-QOL/Sym - 26 item

 PROMIS Cognitive Function 6a

X

X

X

 PROMIS Global Health Scale - 10 item

X

X

X

 PROMIS Anxiety 6a

X

X

X

 PROMIS Fatigue 6a

X

X

X

 PROMIS Pain Interference 6b

X

X

X

 PROMIS Sleep Disturbance 6a

X

X

X

 Katz Activities of Daily Living - 6 item

X

X

X

 Mini-nutritional status - 7 item

X

X

X

 UCLA Loneliness Scale - 20 item

X

X

X

 Medical Outcomes Social Support Survey - 19 item

X

X

X

 Patient Health Questionnaire - 9 item

X

X

X

 The Stigma Scale: Body Image and the Skin - 8 item

X

X

X

 Blood Sample: RNA for deep sequencing analysis*

X

X

X

  1. *Chemotaxic factors: CCL2/JE/MCP-, CCL3/MIP-1 alpha, CCL4/MIP-1 beta, Granzyme B, CCL5/RANTES, CCL11/Eotaxin, CCL19/MIP-3 Beta, CCL20/MIP-3 alpha, CX3CL1/Fractalkine, PD-L1/B7-H1, CXCL1/GRO alpha/KC/CINC-1, CXCL2/GRO, and CXCL10
  2. *Immune regulators: IL-3, IL-4, IL-5, IL-6, IL-7, IL-8/CXCL8, IL-10, IL-12 p70, IFN-alpha IL-13, IFN-beta IL-15, IFN-gamma IL-17/IL-17A, IL-1 alpha/IL-1F1, IL-17E/IL-25 CD40 Ligand/TNFSF5, IL-1 beta/IL-1F2, IL-33, IL-1ra/IL-1F3, and IL-2
  3. *Vascular damage: VCAM, ICAM, CRP, MMP-1, MMP-3, and MMP-
  4. *Growth factors: PDGF-AB/BB, TGF-alpha, EGF, TNF-alpha, FGF basic/FGF2 Flt-3 Ligand TRAIL, G-CSF, GM-CSF, VEGF, and PDGF-AA