Data collection forms

Appendix 3 Data Collection Forms

Form

Time of Use

No. Items

No . Pages

Forms completed per participant Initial registration Eligibility assessment Qualifying blood pressure Eligibility and baseline data Enrollment: I Enrollment: II Stud y information Participant location information Interven tion evalua tion .Semiannual data collection visit: I Semiann ual data collection visit: Il Annual data collection visit: I Annual data collection visit: Il Annual data collection visit: III Diastolic BP alert Missed data collection visit Missed intervention contact Dropout and noncomplier Preliminary death rep ort Final dea th report Serum test requisition 24-hour food record Overnight urine collection and food record Participant visit rem inder Laboratory serum report Laboratory urine report Urine test requisition Laboratory review Nonprotocol inte rvention contact Random allocation to stu dy group Parti cipant data collection appointment schedule Food coding center parti cipant registration Con trolled Clinical Trials 10:1135-1145 (1989) It> Elsevie r Science Pub lishing Co ., Inc. 1989 655 Avenue of Am ericas, New York, New York 10010

BL 1 BL 1 BL 2 BL 2 BL 3 BL 3 BL 2, BL 3

30 17 53 35 29 34 15

4 4 9 8 5 5 5

BL 3, FU 2,4,6 IE FU 1,3,5 FU 1,3,5 FU 2,4,6 FU 2,4,6 FU 2,4,6

14 35 41

7 5

35

6

42 46 35

9 6

20

4

9 11

19

2 2 4

13

2

8

1

7 N/A

1 23

14

5

6

1

26 3

1 1 1

2 wk after DBP ~ 95 mm Hg Missed FU visit Missed IE visit 12 mo after 1st missed FU Within 48 hr of death After assembly of all death records BL 2, annual FUs BL 2, BL 3, IE, All FUs BL 2, BL 3, IE, All FUs BL 1,2,3, IE, All FUs BL 3, Annual FUs BL 3, IE, All FUs BL 3, IE, All FUs FU 2,4,6 All FUs BL 3 BL 3 BL 3

7 9

7 7

2

7 8 N/A

2 1 1

7

1

1135 0197-2456119891$3.50

1145

Ap pe ndix 3

Form Random da y assignment schedule (food record and urine collection)

Time of u se

No. items

No . pages

BL 3, IE, All FUs

N/A

1

Each in tervention con tact Each group session With each mailing

16

5

11

8

16

2

44

14

13

2

16 8

3 1

30

6

33 7 6 29 8

12 1 1

Annually Annually

24

3

8

I

Y Stethoscope certification and recer tifieation

6mo

28

4

BP procedure checklist BP training tape

6mo 6 mo

58 7

5 1

External monitoring of FCC Ancillary study proposal Ancillary study approval HPT data file request HP T data file transmittal Insp ection and maintenance log Shipping log

As needed As needed As ne eded As ne ed ed As needed Monthly As ne eded

5 10 6

1 2 1

14

4

6 N /A

1 1

Forms completed per counseling group Contact session Contact summary Inte rvention mailing report

Forms for study administration and management Clinic certification and specification Cohort specification Request for staff certification number Candidate screening log HPT (staff) knowledge as ses sme n t Clinic recertificat ion Personnel recertification Certification closeout HPT (staff) kno wledge ass essment Skinfold observer certi fication and recertification Skin fold procedure checkli st Height-weight observer certification and recertification

Total number of forms (58) Total number of items, all forms (475) Total number of pages, all forms (229)

Prior to start of clinic activity Prior to cohort formation As needed Daily during recruitment At ini tial certification Annually Annually As needed For recertification Annually

5

5 I

I