1 |
[study_id] |
Study ID |
text |
2 |
[date_enrolled] |
Section Header: Consent Information
Date subject signed consentYYYY-MM-DD
|
text (date_ymd) |
3 |
[first_name] |
Section Header: Contact Information
First Name
|
text, Identifier |
4 |
[last_name] |
Last Name |
text, Identifier |
5 |
[dob] |
Date of birth |
text (date_ymd), Identifier |
6 |
[ethnicity] |
Ethnicity |
radio0 | Hispanic or Latino | 1 | NOT Hispanic or Latino | 2 | Unknown / Not Reported |
Custom alignment: LH |
7 |
[race] |
Race |
dropdown0 | American Indian/Alaska Native | 1 | Asian | 2 | Native Hawaiian or Other Pacific Islander | 3 | Black or African American | 4 | White | 5 | More Than One Race | 6 | Unknown / Not Reported |
|
8 |
[gender] |
Gender |
radio0 | Female | 1 | Male | 2 | Other | 3 | Prefer not to say |
|
9 |
[demographics_complete] |
Section Header: Form Status
Complete?
|
dropdown0 | Incomplete | 1 | Unverified | 2 | Complete |
|
10 |
[randomization_group] |
Section Header: General Comments
Randomization Group
|
dropdown |
11 |
[randomization_form_complete] |
Section Header: Form Status
Complete?
|
dropdown0 | Incomplete | 1 | Unverified | 2 | Complete |
|
12 |
[date_visit_b] |
Section Header: Baseline Measurements
Date of baseline visit
|
text (date_ymd) |
13 |
[date_blood_b] |
Date blood was drawn |
text (date_ymd) |
14 |
[alb_b] |
Serum Albumin (g/dL) |
text (integer, Min: 3, Max: 5) |
15 |
[prealb_b] |
Serum Prealbumin (mg/dL) |
text (number, Min: 10, Max: 40) |
16 |
[creat_b] |
Creatinine (mg/dL) |
text (number, Min: 0.5, Max: 20) |
17 |
[npcr_b] |
Normalized Protein Catabolic Rate (g/kg/d) |
text (number, Min: 0.5, Max: 2) |
18 |
[chol_b] |
Cholesterol (mg/dL) |
text (number, Min: 100, Max: 300) |
19 |
[transferrin_b] |
Transferrin (mg/dL) |
text (number, Min: 100, Max: 300) |
20 |
[kt_v_b] |
Kt/V |
text (number, Min: 0.9, Max: 3) |
21 |
[drywt_b] |
Dry weight (kilograms) |
text (number, Min: 35, Max: 200) |
22 |
[plasma1_b] |
Collected Plasma 1? |
dropdown |
23 |
[plasma2_b] |
Collected Plasma 2? |
dropdown |
24 |
[plasma3_b] |
Collected Plasma 3? |
dropdown |
25 |
[serum1_b] |
Collected Serum 1? |
dropdown |
26 |
[serum2_b] |
Collected Serum 2? |
dropdown |
27 |
[serum3_b] |
Collected Serum 3? |
dropdown |
28 |
[sga_b] |
Subject Global Assessment (score = 1-7) |
text (number, Min: 0.9, Max: 7.1) |
29 |
[date_supplement_dispensed] |
Date patient begins supplement |
text (date_ymd) |
30 |
[baseline_data_complete] |
Section Header: Form Status
Complete?
|
dropdown0 | Incomplete | 1 | Unverified | 2 | Complete |
|
31 |
[date_visit_1] |
Section Header: Month 1
Date of Month 1 visit
|
text (date_ymd) |
32 |
[alb_1] |
Serum Albumin (g/dL) |
text (number, Min: 3, Max: 5) |
33 |
[prealb_1] |
Serum Prealbumin (mg/dL) |
text (number, Min: 10, Max: 40) |
34 |
[creat_1] |
Creatinine (mg/dL) |
text (number, Min: 0.5, Max: 20) |
35 |
[npcr_1] |
Normalized Protein Catabolic Rate (g/kg/d) |
text (number, Min: 0.5, Max: 2) |
36 |
[chol_1] |
Cholesterol (mg/dL) |
text (number, Min: 100, Max: 300) |
37 |
[transferrin_1] |
Transferrin (mg/dL) |
text (number, Min: 100, Max: 300) |
38 |
[kt_v_1] |
Kt/V |
text (number, Min: 0.9, Max: 3) |
39 |
[drywt_1] |
Dry weight (kilograms) |
text (number, Min: 35, Max: 200) |
40 |
[no_show_1] |
Number of treatments missed |
text (number, Min: 0, Max: 7) |
41 |
[compliance_1] |
How compliant was the patient in drinking the supplement? |
dropdown0 | 100 percent | 1 | 99-75 percent | 2 | 74-50 percent | 3 | 49-25 percent | 4 | 0-24 percent |
|
42 |
[hospit_1] |
Section Header: Hospitalization Data
Was patient hospitalized since last visit?
|
dropdown |
43 |
[cause_hosp_1] |
What was the cause of hospitalization? |
dropdown1 | Vascular access related events | 2 | CVD events | 3 | Other |
|
44 |
[admission_date_1] |
Date of hospital admission |
text (date_ymd) |
45 |
[discharge_date_1] |
Date of hospital discharge |
text (date_ymd) |
46 |
[discharge_summary_1] |
Discharge summary in patients binder? |
dropdown |
47 |
[death_1] |
Section Header: Mortality Data
Has patient died since last visit?
|
dropdown |
48 |
[date_death_1] |
Date of death |
text (date_ymd) |
49 |
[cause_death_1] |
What was the cause of death? |
dropdown1 | All-cause | 2 | Cardiovascular |
|
50 |
[month_1_data_complete] |
Section Header: Form Status
Complete?
|
dropdown0 | Incomplete | 1 | Unverified | 2 | Complete |
|
51 |
[date_visit_2] |
Section Header: Month 2
Date of Month 2 visit
|
text (date_ymd) |
52 |
[alb_2] |
Serum Albumin (g/dL) |
text (number, Min: 3, Max: 5) |
53 |
[prealb_2] |
Serum Prealbumin (mg/dL) |
text (number, Min: 10, Max: 40) |
54 |
[creat_2] |
Creatinine (mg/dL) |
text (number, Min: 0.5, Max: 20) |
55 |
[npcr_2] |
Normalized Protein Catabolic Rate (g/kg/d) |
text (number, Min: 0.5, Max: 2) |
56 |
[chol_2] |
Cholesterol (mg/dL) |
text (number, Min: 100, Max: 300) |
57 |
[transferrin_2] |
Transferrin (mg/dL) |
text (number, Min: 100, Max: 300) |
58 |
[kt_v_2] |
Kt/V |
text (number, Min: 0.9, Max: 3) |
59 |
[drywt_2] |
Dry weight (kilograms) |
text (number, Min: 35, Max: 200) |
60 |
[no_show_2] |
Number of treatments missed |
text (number, Min: 0, Max: 7) |
61 |
[compliance_2] |
How compliant was the patient in drinking the supplement? |
dropdown0 | 100 percent | 1 | 99-75 percent | 2 | 74-50 percent | 3 | 49-25 percent | 4 | 0-24 percent |
|
62 |
[hospit_2] |
Section Header: Hospitalization Data
Was patient hospitalized since last visit?
|
dropdown |
63 |
[cause_hosp_2] |
What was the cause of hospitalization? |
dropdown1 | Vascular access related events | 2 | CVD events | 3 | Other |
|
64 |
[admission_date_2] |
Date of hospital admission |
text (date_ymd) |
65 |
[discharge_date_2] |
Date of hospital discharge |
text (date_ymd) |
66 |
[discharge_summary_2] |
Discharge summary in patients binder? |
dropdown |
67 |
[death_2] |
Section Header: Mortality Data
Has patient died since last visit?
|
dropdown |
68 |
[date_death_2] |
Date of death |
text (date_ymd) |
69 |
[cause_death_2] |
What was the cause of death? |
dropdown1 | All-cause | 2 | Cardiovascular |
|
70 |
[month_2_data_complete] |
Section Header: Form Status
Complete?
|
dropdown0 | Incomplete | 1 | Unverified | 2 | Complete |
|
71 |
[date_visit_3] |
Section Header: Month 3
Date of Month 3 visit
|
text (date_ymd) |
72 |
[date_blood_3] |
Date blood was drawn |
text (date_ymd) |
73 |
[alb_3] |
Serum Albumin (g/dL) |
text (number, Min: 3, Max: 5) |
74 |
[prealb_3] |
Serum Prealbumin (mg/dL) |
text (number, Min: 10, Max: 40) |
75 |
[creat_3] |
Creatinine (mg/dL) |
text (number, Min: 0.5, Max: 20) |
76 |
[npcr_3] |
Normalized Protein Catabolic Rate (g/kg/d) |
text (number, Min: 0.5, Max: 2) |
77 |
[chol_3] |
Cholesterol (mg/dL) |
text (number, Min: 100, Max: 300) |
78 |
[transferrin_3] |
Transferrin (mg/dL) |
text (number, Min: 100, Max: 300) |
79 |
[kt_v_3] |
Kt/V |
text (number, Min: 0.9, Max: 3) |
80 |
[drywt_3] |
Dry weight (kilograms) |
text (number, Min: 35, Max: 200) |
81 |
[plasma1_3] |
Collected Plasma 1? |
dropdown |
82 |
[plasma2_3] |
Collected Plasma 2? |
dropdown |
83 |
[plasma3_3] |
Collected Plasma 3? |
dropdown |
84 |
[serum1_3] |
Collected Serum 1? |
dropdown |
85 |
[serum2_3] |
Collected Serum 2? |
dropdown |
86 |
[serum3_3] |
Collected Serum 3? |
dropdown |
87 |
[sga_3] |
Subject Global Assessment (score = 1-7) |
text (number, Min: 0.9, Max: 7.1) |
88 |
[no_show_3] |
Number of treatments missed |
text (number, Min: 0, Max: 7) |
89 |
[compliance_3] |
How compliant was the patient in drinking the supplement? |
dropdown0 | 100 percent | 1 | 99-75 percent | 2 | 74-50 percent | 3 | 49-25 percent | 4 | 0-24 percent |
|
90 |
[hospit_3] |
Section Header: Hospitalization Data
Was patient hospitalized since last visit?
|
dropdown |
91 |
[cause_hosp_3] |
What was the cause of hospitalization? |
dropdown1 | Vascular access related events | 2 | CVD events | 3 | Other |
|
92 |
[admission_date_3] |
Date of hospital admission |
text (date_ymd) |
93 |
[discharge_date_3] |
Date of hospital discharge |
text (date_ymd) |
94 |
[discharge_summary_3] |
Discharge summary in patients binder? |
dropdown |
95 |
[death_3] |
Section Header: Mortality Data
Has patient died since last visit?
|
dropdown |
96 |
[date_death_3] |
Date of death |
text (date_ymd) |
97 |
[cause_death_3] |
What was the cause of death? |
dropdown1 | All-cause | 2 | Cardiovascular |
|
98 |
[month_3_data_complete] |
Section Header: Form Status
Complete?
|
dropdown0 | Incomplete | 1 | Unverified | 2 | Complete |
|
99 |
[complete_study] |
Section Header: Study Completion Information
Has patient completed study?
|
dropdown |
100 |
[withdraw_date] |
Put a date if patient withdrew study |
text (date_ymd) |
101 |
[withdraw_reason] |
Reason patient withdrew from study |
dropdown0 | Non-compliance | 1 | Did not wish to continue in study | 2 | Could not tolerate the supplement | 3 | Hospitalization | 4 | Other |
|
102 |
[complete_study_date] |
Date of study completion |
text (date_ymd) |
103 |
[study_comments] |
Section Header: General Comments
Comments
|
notes |
104 |
[completion_data_complete] |
Section Header: Form Status
Complete?
|
dropdown0 | Incomplete | 1 | Unverified | 2 | Complete |
|