Table 1.
Schedule of measurements and activities by visit for the PACE study
Baseline visit | Follow-up (FU) Visits and Telephone (T) Contacts | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
EV | BV | T4 | T6 | T8 | FU12 | T16 | T18 | T20 | FU24 | Up to FU48 | |
Interviewer/Questionnaires § | |||||||||||
Informed consent | ● | ||||||||||
Contact information | ● | ● | ● | ● | ● | ● | |||||
Sociodemographic | ● | ||||||||||
Education and employment | ● | ● | ● | ● | |||||||
Vascular access | ● | ● | ● | ● | |||||||
Residual kidney function | ● | ● | ● | ● | |||||||
Dialysis prescription | ● | ● | ● | ● | |||||||
Dialysis adherence | ● | ● | ● | ● | |||||||
Pre-dialysis education | ● | ● | ● | ● | |||||||
Medical history | ● | ● | ● | ● | ● | ● | |||||
Family history of CVD, SCD | ● | ||||||||||
Female reproductive history | ● | ● | ● | ● | |||||||
Health, behaviour, social history | ● | ● | ● | ● | |||||||
Access to transplant | ● | ● | ● | ● | |||||||
KDQOL-36 | ● | ● | ● | ● | |||||||
Symptomatic CVD (Rose, KCQ) | ● | ● | ● | ● | |||||||
Physical activity | ● | ● | ● | ● | |||||||
Dietary questions & 24-hr recall | ● | ● | ● | ● | ● | ● | ● | ● | |||
Literacy (WRAT4) | ● | ||||||||||
Cognition (Trails A&B, 3MS) | ● | ● | ● | ● | |||||||
Depression (PHQ9) | ● | ● | ● | ● | |||||||
Oral medications | ● | ● | ● | ● | |||||||
Examination | |||||||||||
Height, weight, BMI, WHR | ● | ● | ● | ● | |||||||
Blood pressures | ● | ● | ● | ● | |||||||
Detailed amputation evaluation | ● | ● | ● | ● | |||||||
Frailty assessment | ● | ● | ● | ● | |||||||
Procedures | |||||||||||
CT calcium and angiography | ● | ||||||||||
Echocardiography | ● | ||||||||||
Pulse wave velocity | ● | ● | ● | ● | |||||||
12 lead & signal averaged ECG | ● | ● | ● | ● | |||||||
4 Limb ankle brachial | ● | ● | ● | ● | |||||||
Blood tests (fasting) | |||||||||||
Ionized calcium, magnesium | ● | ● | ● | ● | |||||||
Repository (DNA, RNA, blood, nails) | ● | ● | ● | ● | |||||||
Clinical | |||||||||||
Baseline charlson co-morbidity | ● | ||||||||||
CMS-2728 medical evidence | ● | ||||||||||
Hospitalizations | Throughout the entire study period | ||||||||||
CMS-2746 death notification‡ | Collect as needed | ||||||||||
Dialysis routine bloods (monthly) | Throughout the entire study period | ||||||||||
Glucose, albumin | |||||||||||
Complete blood count | |||||||||||
Electrolytes (Na, K, Mg, CO2, Ca, Phos)* | |||||||||||
Intact PTH* | |||||||||||
Fe, TIBC, Ferritin, Aluminum* | |||||||||||
URR, spKt/V, nPCR* | |||||||||||
Dialysis treatments (weekly) ‡‡ | Throughout the entire study period | ||||||||||
Dry weight | |||||||||||
Dialysis bath (Ca, K, HCO3)* | |||||||||||
Prescription (duration, frequency, dialyzer) | |||||||||||
Pre and post weights | |||||||||||
Pre and post blood pressures (BP) | |||||||||||
Dialysis flow rate | |||||||||||
Blood flow rate | |||||||||||
Intravenous medications |
§KCQ = Kansas City Questionnaire; KDQOL-36 = Kidney Disease Quality of Life 36 Item Instrument; WRAT4 = Wide Range Achievement Test 4th Edition; Trails A&B; 3MS = Modified Mini-Mental Status Exam; PHQ9 = Patient Health Questionnaire 9; ¶BMI = Body Mass Index; WHR = Waist Hip Ratio; Blood Pressure is collected as 3 seated Blood Pressures; ‡Collected as needed; *Na- sodium K- potassium; Ca- calcium; Phos- phosphorus; HCO3- bicarbonate; PTH- parathyroid hormone level; Fe- iron; TIBC- total iron binding capacity; URR- urea reduction ratio; nPCR- nitrogen protein catabolic rate; ‡‡Dialysis Machine Derived Parameters: BP-pre, BP-post, Lowest BP, Weight-pre, Weight-post, Intradialytic Weight Gain, & Average Blood Flow Rate.