DATA GUIDEBOOK
Off Protocol Form
(OP)
Off Protocol Form (OP)
Index
Introduction
Specific Instructions
Dataset Summary...... 6
Frequencies...... 8
OFF PROTOCOL (OP)
Introduction
PURPOSE:This form is used to document any occurrences which are protocol variations (do not adhere to standards established in the protocol).
TIME OF DATA COLLECTION:At the time of awareness of any occurrences which are protocol variations.
REQUIRED RESPONSE CARD(S):Nonerequired.
GENERAL INSTRUCTIONS:
Protocol deviations can occur at different time points or can be initiated by a caregiver who chooses to discontinue in the study. This form should be filled out for any variation, unless it is clear that the variation is still within the protocol. Most notably, if there is a change in status of the care recipient such as items 28.4.2 and 28.5 but the caregiver does not discontinue participation in the REACH II project, then this information is not recorded on this form but is recorded on the Care Recipient Tracking (RT) form and, if appropriate, on the Adverse Events (AE) form as well.
Specific Instructions:
Subject ID: Enter the subject ID that is generated by the active/correct screening form. In the case where a subject ID was generated and that screening becomes invalid, the off protocol will have the new screening number entered in the subject ID space, and the old screening ID will be entered in the space provided in question 4.1.
Question 1: Enter the date that this form was completed, in the form two digits for month (e.g. 01 for January, 12 for December), two digits for day (e.g. 01, 02, 03...., 31), and four digits for the year. August 14, 2002 would be recorded as 08/14/2002. This is not necessarily the date that the off-protocol event occurred but the date that this form was completed. If the caregiver is off-protocol because the caregiver has discontinued participating in the REACH project and a discontinued interview (DI) has been administered, this date should be the same as the date of the discontinued interview (DI).
Question 2: After entering the name of the interviewer, enter thecertification number of the person conducting the interview. This number is assigned to each interviewer by the Coordinating Center. Completion of this form should only be done by individuals certified for the tracking forms. If for some reason this form was completed by a non-certified individual leave this space blank.
PROTOCOL DEVIATIONS (please check all that apply)
SCREENING
3. Rescreening occurred after baseline.
Check this item if the baseline interview was conducted more than 30 days after the initial screening and the rescreening did not occur before the baseline interview. The new screening needs to be done
at the same time as this Off Protocol (OP) form is completed. The subject ID generated from the new screen is entered in the space on the top right hand corner of this form. The subject ID from the first screen will be entered in item 3.1. If the baseline battery has not been entered into PoP, the subject ID on the baseline battery needs to be changed to match the new screen. If the baseline battery has been entered into PoP already, contact the data center to change the ID for the entered baseline battery.
RANDOMIZATION
4. Ineligible participant randomized.
Check this item if a caregiver was admitted to the study but was later found out to be ineligible when randomized.
5. Wrong treatment assigned.
Check this item if the treatment was wrongly assigned by the coordinating center.
6. Wrong treatment given.
Check this item if the caregiver was randomized to a group and then received the other group treatment, control person receives intervention or intervention person receives control condition.
7. Randomization more than 3 days from baseline interview.
Check this item if the randomization was conducted more than 3 days from the baseline interview.
8. Randomization completed prior to baseline interview.
Check this item if the participant was randomized before the baseline interview was completed.
9. Eligible participant not randomized; specify: ______
Check this item if the participant was not randomized but was eligible for the study.
10. Participant randomized to wrong stratum.
Check this item if the participant was randomized to the wrong stratum.
If yes,
10.1 Specify which stratum (check all that apply):
a. If the wrong stratum was the CG relation to CR, check “CG relation to CR” and then check the incorrect relationship (non-spouse or spouse) and the correct relationship (non-spouse or spouse).
b. If the wrong stratum was CG identity, check “CG identity” and then check the incorrect identity (Hispanic, White, Black) and the correct identity (Hispanic, White, Black).
CORE BATTERY
11. Interview conducted by non-certified individual.
Check this item if an interview was done by someone who has not been certified. If the entire interview was conducted by a non-certified interviewer, it is not to be entered into the database. If this occurred at baseline, the caregiver is not eligible for the study and an Off-Protocol form does not need to be filled out. If this occurred at a follow-up assessment, an Off-Protocol form is completed indicating that the entire interview was conducted by a non-certified interviewer.
12. Interview completed over the phone.
Check this item if the interview was completed over the phone instead of in person. The one exception is the discontinued battery which is designed to be conducted over the phone and would not be off protocol.
13. Follow-up missed.
Check this item if one of the three follow-up contacts is missed: 3-month control call, 5-month control call or six month follow- up visit. In question 13.1 check the specific follow-up contact that is missed.
Special notes regarding the 3- & 5-month control calls:
- If 4 weeks has passed from the actual due date of the 3-month control call, the call is considered as missed - no further attempt should be made to complete the call.
- If 4 weeks has passed from the actual due date of the 5-month control call, the call is considered as missed – no further attempt should be made to complete the call.
- A 5-month control call must be made prior to a 6-month follow-up interview.
14. Follow-up completed outside of the window.
Check this item if one of the three follow-up contacts is outside the window: 3-month control call, 5-month control call or six month follow- up visit. In question 13.1 check the specific follow-up contact that is outside the window. The 3-month control call and the 5-month control call must take place within the window prescribed (two weeks prior through two weeks past the due date for the 3-month or 5-month call). Check the remaining option if the caregiver’s follow-up visit was not conducted within the six month follow-up window (7 days prior + 30 days past six month time point) but the caregiver remains active in the study.
15. Project Evaluation not completed.
Check if the project evaluation was not completed at the end of the follow-up, bereavement or placement battery interview.
16. Mini-Mental completed at a different time than core battery.
Check this item if interviewer needed to complete the mini- mental at a different time than the battery. A baseline battery may not be completed at the same time as the mini-mental, due to a score of greater than 23 on the MMSE and a need to get a MD diagnosis of dementia. But if a baseline battery or follow-up battery is completed, the mini- mental should be completed at the same time.
17. Mini-Mental not completed.
Check this item if the mini-mental is never completed on the care recipient.
18. Interview required multiple sessions.
Check this item if the interview was stopped before it was completed and required more than one visit to complete the interview.
INTERVENTION
19. First intervention session greater than 21 days from randomization.
Check this item if the first intervention session is greater than 21 calendar days past randomization.
INTERVENTION REFUSALS
20. CTIS phone.
Check this item if the caregiver refuses to have the CTIS phone system installed in his or her home.
21. Participation in CTIS support groups.
Check this item if the caregiver refuses to join a CTIS support group.
22. Caregiver notebook.
Check this item if the caregiver does not accept the caregiver notebook from the interventionist.
23. Home visits.
Check this item if the caregiver refuses to have the interventionist come to his or her home.
24. Behavioral prescriptions.
Check this item if the caregiver refuses to participate in the behavioral prescriptions developed for his or her intervention.
25. Stress management module.
Check this item if the caregiver refuses to participate in the stress management module presented by the interventionist.
26. Further participation in intervention.
Check this item if the caregiver refuses to participate in the intervention entirely.
ENDPOINT DATA UNAVAILABLE (Check all that apply)
27. Interview incomplete – Caregiver withdraw consent after interview started.
Check this item if the interview as started but not completed because the CG had withdrew consent (for any reason) after the interview started and before it had ended.
28. Caregiver withdraws consent.
28.1Change of caregiver.
Check this item if the primary caregiver has changed and the original caregiver no longer wishes to participate in the REACH II project. If there is a change of caregiver but the original caregiver continues to participate in REACH II this information should not be recorded here but should be recorded on the Care Recipient Tracking (RT) form. Do not check this item if the reason for the change of caregiver is death of the caregiver. That information should be recorded in item 27.
28.2. Caregiver felt that the study was too time consuming
Check this item if the caregiver states that they will no longer participate in the REACH II project because the REACH II project is taking up too much of their time.
28.3. Caregiver is displeased with randomization
Caregiver has been assigned to either the intervention group or control group and they decide they are unhappy with this assignment and withdraw consent to participate.
28.4. Illness
Check this item if the caregiver states that he or she will no longer continue in the REACH II project secondary to any illness of either the caregiver or the care recipient. This item will include situations where the caregiver or care recipient has been institutionalized in a long term care facility and chooses not to continue participation in the project.
28.5 Care RecipientDeath
Check this item if the caregiver states that he or she will no longer continue in the REACH II project due to the care recipient’s death.
28.6 Other reason; specify:______
Specify another reason not listed that the caregiver chooses to discontinue in the study.
29. Caregiver cannot be located / location unknown
30. Caregiver Death
Check this item if there is a death of the caregiver.
31. Caregiver excluded from study; Specify
Check this item if the CG was excluded from the study (for any reason) and specify the reason in the specify box.
OTHER PROTOCOL DEVIATION
32. Other: Specify:______
Specify another reason not listed that the subject is off protocol.
DATASET SUMMARY
THE CONTENTS PROCEDURE
Data Set Name: WORK.OP Observations: 547
Member Type: DATA Variables: 58
Engine: V8 Indexes: 0
Created: 13:10 Friday, September 2, 2005 Observation Length: 624
Last Modified: 13:10 Friday, September 2, 2005 Deleted Observations: 0
Protection: Compressed: NO
Data Set Type: Sorted: NO
Label:
-----Variables Ordered by Position-----
# Variable Type Len Format Label
______
1 ID Char 7 Subject ID
2 OPDAT Num 8 MMDDYY10. OP date of interview
3 SGTBA Num 8 Rescreening after baseline
4 OLD2 Char 7 New Screening ID
5 INELR Num 8 Ineligible pt randomized
6 WTMTA Num 8 Wrong treatment assigned
7 WTMTG Num 8 Wrong treatment given
8 RLATE Num 8 Random gt 3 days from baseline
9 RBFRB Num 8 Random before baseline
10 EPNRN Num 8 Eligible pt not randomized
11 SEPNR Char 25 Eligible pt not RD specify
12 WSTRA Num 8 Pt random wrong stratum
13 CGCR Num 8 Wrong stratum CG relation
14 RELAI Num 8 CG relation wrong
15 RELAC Num 8 CG relation correct
16 CGID Num 8 Wrong stratum CG identity
17 IDI Num 8 CG identity wrong
18 IDC Num 8 CG identity correct
19 NONC Num 8 Interview by non certified
20 PHDON Num 8 Interview by phone
21 FOMIS Num 8 Follow up missed
22 MISS Num 8 Specify missed follow-up
23 FOOUT Num 8 Follow up out of window
24 LATE Num 8 Specify which FU out window
25 PENCO Num 8 PE not completed
26 MMDCB Num 8 Diff time core battery
27 MMNCO Num 8 Mini-Mental not completed
28 IRMSS Num 8 Inter required multi sessions
29 NUMSS Num 8 Num sessions complete interview
30 IGT21 Num 8 First intervention gt 21
31 CTISP Num 8 CTIS phone
32 CTISS Num 8 Pt CTIS support group
33 CGNBK Num 8 CG notebook
34 HOMEV Num 8 Home visits
35 BEHPR Num 8 Behavioral prescription
36 SMNGM Num 8 Stress management module
37 INALL Num 8 Further pt in intervention
38 INCO Num 8 Interview incomplete
39 INCOS Char 30 Specify why incomplete
DATASET SUMMARY (continued)
-----Variables Ordered by Position-----
# Variable Type Len Format Label
______
40 CGWCN Num 8 CG withdraws consent
41 CHCG Num 8 Change of CG
42 CGFST Num 8 CG felt study too time consuming
43 CGDRN Num 8 CG displeased w/random
44 ILLNS Num 8 Illness
45 ILLCG Num 8 Illness of CG
46 ILLCR Num 8 Illness of CR
47 CRDE Num 8 CR death
48 CGWOR Num 8 Other reason
49 ORSPE Char 20 Specify other reason
50 LOCUK Num 8 CG cannot be located
51 CGDE Num 8 CG death
52 CGEXC Num 8 CG excluded from study
53 EXC1 Char 30 Specify CG excluded 1
54 EXC2 Char 30 Specify CG excluded 2
55 OTOP Num 8 Other off protocol
56 OTOP1 Char 40 Specify off protocol 1
57 OTOP2 Char 40 Specify off protocol 2
58 CERT Num 8 OP REACH certification number
FREQUENCIES
Rescreening after Baseline
Cumulative Cumulative
SGTBA Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
0 530 96.89 547 100.00
New Screening ID
Cumulative Cumulative
OLD2 Frequency Percent Frequency Percent
______
-2 547 100.00 547 100.00
Ineligible pt randomized
Cumulative Cumulative
INELR Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
0 525 95.98 542 99.09
1 5 0.91 547 100.00
Wrong treatment assigned
Cumulative Cumulative
WTMTA Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
0 530 96.89 547 100.00
Wrong treatment given
Cumulative Cumulative
WTMTG Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
0 530 96.89 547 100.00
Random gt 3 days from baseline
Cumulative Cumulative
RLATE Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
0 499 91.22 516 94.33
1 31 5.67 547 100.00
FREQUENCIES (continued)
Random before baseline
Cumulative Cumulative
RBFRB Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
0 530 96.89 547 100.00
Eligible pt not randomized
Cumulative Cumulative
EPNRN Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
0 530 96.89 547 100.00
Eligible pt not RD specify
Cumulative Cumulative
SEPNR Frequency Percent Frequency Percent
______
-2 547 100.00 547 100.00
Pt random wrong stratum
Cumulative Cumulative
WSTRA Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
-1 21 3.84 38 6.95
0 502 91.77 540 98.72
1 7 1.28 547 100.00
Wrong stratum CG relation
Cumulative Cumulative
CGCR Frequency Percent Frequency Percent
______
-2 522 95.43 522 95.43
-1 18 3.29 540 98.72
0 4 0.73 544 99.45
1 3 0.55 547 100.00
FREQUENCIES (continued)
CG relation wrong
Cumulative Cumulative
RELAI Frequency Percent Frequency Percent
______
-2 526 96.16 526 96.16
-1 18 3.29 544 99.45
1 2 0.37 546 99.82
2 1 0.18 547 100.00
CG relation correct
Cumulative Cumulative
RELAC Frequency Percent Frequency Percent
______
-2 526 96.16 526 96.16
-1 18 3.29 544 99.45
1 1 0.18 545 99.63
2 2 0.37 547 100.00
Wrong stratum CG identity
Cumulative Cumulative
CGID Frequency Percent Frequency Percent
______
-2 522 95.43 522 95.43
-1 18 3.29 540 98.72
0 3 0.55 543 99.27
1 4 0.73 547 100.00
CG identity wrong
Cumulative Cumulative
IDI Frequency Percent Frequency Percent
______
-2 525 95.98 525 95.98
-1 18 3.29 543 99.27
2 1 0.18 544 99.45
3 3 0.55 547 100.00
CG identity correct
Cumulative Cumulative
IDC Frequency Percent Frequency Percent
______
-2 525 95.98 525 95.98
-1 18 3.29 543 99.27
2 3 0.55 546 99.82
3 1 0.18 547 100.00
FREQUENCIES (continued)
Interview by non certified
Cumulative Cumulative
NONC Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
0 530 96.89 547 100.00
Interview by phone
Cumulative Cumulative
PHDON Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
0 517 94.52 534 97.62
1 13 2.38 547 100.00
Follow up missed
Cumulative Cumulative
FOMIS Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
0 504 92.14 521 95.25
1 26 4.75 547 100.00
Specify missed follow-up
Cumulative Cumulative
MISS Frequency Percent Frequency Percent
______
-2 521 95.25 521 95.25
1 11 2.01 532 97.26
2 13 2.38 545 99.63
3 2 0.37 547 100.00
Follow up out of window
Cumulative Cumulative
FOOUT Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
0 363 66.36 380 69.47
1 167 30.53 547 100.00
FREQUENCIES (continued)
Specify which FU out window
Cumulative Cumulative
LATE Frequency Percent Frequency Percent
______
-2 380 69.47 380 69.47
1 35 6.40 415 75.87
2 36 6.58 451 82.45
3 96 17.55 547 100.00
PE not completed
Cumulative Cumulative
PENCO Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
0 528 96.53 545 99.63
1 2 0.37 547 100.00
Diff time core battery
Cumulative Cumulative
MMDCB Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
0 508 92.87 525 95.98
1 22 4.02 547 100.00
Mini-Mental not completed
Cumulative Cumulative
MMNCO Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
0 492 89.95 509 93.05
1 38 6.95 547 100.00
Inter required multi sessions
Cumulative Cumulative
IRMSS Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
0 469 85.74 486 88.85
1 61 11.15 547 100.00
FREQUENCIES (continued)
Num sessions complete interview
Cumulative Cumulative
NUMSS Frequency Percent Frequency Percent
______
-2 486 88.85 486 88.85
2 57 10.42 543 99.27
3 4 0.73 547 100.00
First intervention gt 21
Cumulative Cumulative
IGT21 Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
-1 20 3.66 37 6.76
0 448 81.90 485 88.67
1 62 11.33 547 100.00
CTIS phone
Cumulative Cumulative
CTISP Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
0 511 93.42 528 96.53
1 19 3.47 547 100.00
Pt CTIS support group
Cumulative Cumulative
CTISS Frequency Percent Frequency Percent
______
-2 8 1.46 8 1.46
0 487 89.03 495 90.49
1 52 9.51 547 100.00
CG notebook
Cumulative Cumulative
CGNBK Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
0 526 96.16 543 99.27
1 4 0.73 547 100.00
FREQUENCIES (continued)
Home visits
Cumulative Cumulative
HOMEV Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
0 519 94.88 536 97.99
1 11 2.01 547 100.00
Behavioral prescription
Cumulative Cumulative
BEHPR Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
0 525 95.98 542 99.09
1 5 0.91 547 100.00
Stress management module
Cumulative Cumulative
SMNGM Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
0 524 95.80 541 98.90
1 6 1.10 547 100.00
Further pt in intervention
Cumulative Cumulative
INALL Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
0 493 90.13 510 93.24
1 37 6.76 547 100.00
Interview incomplete
Cumulative Cumulative
INCO Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
-1 386 70.57 403 73.67
0 140 25.59 543 99.27
1 4 0.73 547 100.00
FREQUENCIES (continued)
Specify why incomplete
Cumulative Cumulative
INCOS Frequency Percent Frequency Percent
______
-1 380 69.47 380 69.47
-2 163 29.80 543 99.27
AFTER 40 DAYS,WITHDRAW CONSENT 1 0.18 544 99.45
CG REFUSED TO CONTINUE 1 0.18 545 99.63
CR DIED DURING FOLLOW-UP 1 0.18 546 99.82
CR IS IN BAD HEALTH, CG DECIDE 1 0.18 547 100.00
CG withdraws consent
Cumulative Cumulative
CGWCN Frequency Percent Frequency Percent
______
-2 17 3.11 17 3.11
0 496 90.68 513 93.78
1 34 6.22 547 100.00
Change of CG
Cumulative Cumulative
CHCG Frequency Percent Frequency Percent
______
-2 513 93.78 513 93.78
0 34 6.22 547 100.00
CG felt study too time consuming
Cumulative Cumulative
CGFST Frequency Percent Frequency Percent
______
-2 512 93.60 512 93.60
0 24 4.39 536 97.99
1 11 2.01 547 100.00
CG displeased w/random
Cumulative Cumulative
CGDRN Frequency Percent Frequency Percent
______
-2 513 93.78 513 93.78
0 27 4.94 540 98.72
1 7 1.28 547 100.00
FREQUENCIES (continued)
Illness
Cumulative Cumulative
ILLNS Frequency Percent Frequency Percent
______
-2 513 93.78 513 93.78
0 33 6.03 546 99.82
1 1 0.18 547 100.00
Illness of CG