The example illustrates the steps to set up a REDCap project for a 2 x 2 x 2 full factorial design. The intervention components in the example project are: 1) video; 2) support groups; and 3) text messages. Video has brief and detailed levels while the other two intervention components are either on or off.
Longitudinal Project Setup Steps
Main Project Settings
- Enable: Use surveys in this project
- Enable: Use longitudinal data collection with defined events
- Enable: Repeatable instruments and events
- Enable: Scheduling module
- Enable: Randomization module
- Disable: Auto-numbering for records
Arms
Arms will be created to organize events related to the following study parts:
- screening for eligibility
- assessments common to all participants, including locator, a baseline interview, randomization, and two follow-up interviews
- condition-specific events which utilize schedules tailored to individual study conditions and collect data related to the intervention activities in each study condition
Create 10 study arms with Define My Events. Specific intervention conditions have been given fish names.
Instruments
The example project has the following 13 instruments:
1. Unique Id
2. Screening
3. Baseline Interview
4. Patient Health Questionnaire 9
5. GAD-7
6. Brief Video
7. Detailed Video
8. Support Groups
9. Text Messages
10. Locator
11. Randomization Form
12. Core Component Form
13. Randomization Check Form
As described above, instruments can be created via Online Designer or the Data Dictionary.
Events
The example project has the following 41 events across the 10 arms:
Screening and Locator |
1 |
0 |
0 |
20 |
screening_and_loca_arm_1 |
Baseline |
2 |
0 |
0 |
10 |
baseline_arm_2 |
Randomization |
2 |
0 |
0 |
10 |
randomization_arm_2 |
First Follow |
2 |
70 |
10 |
20 |
first_follow_arm_2 |
Second Follow |
2 |
150 |
10 |
20 |
second_follow_arm_2 |
Core |
3 |
0 |
0 |
0 |
core_arm_3 |
Detailed Video |
3 |
1 |
1 |
5 |
detailed_video_arm_3 |
Group 1 |
3 |
10 |
5 |
5 |
group_1_arm_3 |
Group 2 |
3 |
20 |
5 |
5 |
group_2_arm_3 |
Group 3 |
3 |
30 |
5 |
5 |
group_3_arm_3 |
Text Message 1 |
3 |
50 |
5 |
5 |
text_message_1_arm_3 |
Text Message 2 |
3 |
60 |
5 |
5 |
text_message_2_arm_3 |
Core |
4 |
0 |
0 |
0 |
core_arm_4 |
Detailed Video |
4 |
1 |
1 |
5 |
detailed_video_arm_4 |
Text Message 1 |
4 |
10 |
5 |
5 |
text_message_1_arm_4 |
Text Message 2 |
4 |
20 |
5 |
5 |
text_message_2_arm_4 |
Core |
5 |
0 |
0 |
0 |
core_arm_5 |
Detailed Video |
5 |
1 |
1 |
5 |
detailed_video_arm_5 |
Group One |
5 |
10 |
5 |
5 |
group_one_arm_5 |
Group Two |
5 |
20 |
5 |
5 |
group_two_arm_5 |
Group Three |
5 |
30 |
5 |
5 |
group_three_arm_5 |
Core |
6 |
0 |
0 |
0 |
core_arm_6 |
Detailed Video |
6 |
1 |
1 |
5 |
detailed_video_arm_6 |
Core |
7 |
0 |
0 |
0 |
core_arm_7 |
Brief Video |
7 |
1 |
1 |
5 |
brief_video_arm_7 |
Group 1 |
7 |
10 |
5 |
5 |
group_1_arm_7 |
Group 2 |
7 |
20 |
5 |
5 |
group_2_arm_7 |
Group 3 |
7 |
30 |
5 |
5 |
group_3_arm_7 |
Text Message 1 |
7 |
50 |
5 |
5 |
text_message_1_arm_7 |
Text Message 2 |
7 |
60 |
5 |
5 |
text_message_2_arm_7 |
Core |
8 |
0 |
0 |
0 |
core_arm_8 |
Brief Video |
8 |
1 |
1 |
5 |
brief_video_arm_8 |
Text Message 1 |
8 |
10 |
5 |
5 |
text_message_1_arm_8 |
Text Message 2 |
8 |
20 |
5 |
5 |
text_message_2_arm_8 |
Core |
9 |
0 |
0 |
0 |
core_arm_9 |
Brief Video |
9 |
1 |
1 |
5 |
brief_video_arm_9 |
Group 1 |
9 |
10 |
5 |
5 |
group_1_arm_9 |
Group 2 |
9 |
20 |
5 |
5 |
group_2_arm_9 |
Group 3 |
9 |
30 |
5 |
5 |
group_3_arm_9 |
Core |
10 |
0 |
0 |
0 |
core_arm_10 |
Brief Video |
10 |
1 |
1 |
5 |
brief_video_arm_10 |
Instrument Designations
The example project has the following 93 instrument designations. These specify which instruments should be completed during each event.
1 |
screening_and_loca_arm_1 |
screening |
1 |
screening_and_loca_arm_1 |
locator |
2 |
baseline_arm_2 |
baseline_interview |
2 |
baseline_arm_2 |
patient_health_questionnaire_9 |
2 |
baseline_arm_2 |
gad7 |
2 |
baseline_arm_2 |
locator |
2 |
randomization_arm_2 |
randomization_form |
2 |
first_follow_arm_2 |
patient_health_questionnaire_9 |
2 |
first_follow_arm_2 |
gad7 |
2 |
first_follow_arm_2 |
locator |
2 |
second_follow_arm_2 |
patient_health_questionnaire_9 |
2 |
second_follow_arm_2 |
gad7 |
2 |
second_follow_arm_2 |
locator |
3 |
core_arm_3 |
locator |
3 |
core_arm_3 |
core_component_form |
3 |
core_arm_3 |
randomization_check_form |
3 |
detailed_video_arm_3 |
detailed_video |
3 |
detailed_video_arm_3 |
locator |
3 |
group_1_arm_3 |
support_groups |
3 |
group_1_arm_3 |
locator |
3 |
group_2_arm_3 |
support_groups |
3 |
group_2_arm_3 |
locator |
3 |
group_3_arm_3 |
support_groups |
3 |
group_3_arm_3 |
locator |
3 |
text_message_1_arm_3 |
text_messages |
3 |
text_message_1_arm_3 |
locator |
3 |
text_message_2_arm_3 |
text_messages |
3 |
text_message_2_arm_3 |
locator |
4 |
core_arm_4 |
locator |
4 |
core_arm_4 |
core_component_form |
4 |
core_arm_4 |
randomization_check_form |
4 |
detailed_video_arm_4 |
detailed_video |
4 |
detailed_video_arm_4 |
locator |
4 |
text_message_1_arm_4 |
text_messages |
4 |
text_message_1_arm_4 |
locator |
4 |
text_message_2_arm_4 |
text_messages |
4 |
text_message_2_arm_4 |
locator |
5 |
core_arm_5 |
locator |
5 |
core_arm_5 |
core_component_form |
5 |
core_arm_5 |
randomization_check_form |
5 |
detailed_video_arm_5 |
detailed_video |
5 |
detailed_video_arm_5 |
locator |
5 |
group_one_arm_5 |
support_groups |
5 |
group_one_arm_5 |
locator |
5 |
group_two_arm_5 |
support_groups |
5 |
group_two_arm_5 |
locator |
5 |
group_three_arm_5 |
support_groups |
5 |
group_three_arm_5 |
locator |
6 |
core_arm_6 |
locator |
6 |
core_arm_6 |
core_component_form |
6 |
core_arm_6 |
randomization_check_form |
6 |
detailed_video_arm_6 |
detailed_video |
6 |
detailed_video_arm_6 |
locator |
7 |
core_arm_7 |
locator |
7 |
core_arm_7 |
core_component_form |
7 |
core_arm_7 |
randomization_check_form |
7 |
brief_video_arm_7 |
brief_video |
7 |
brief_video_arm_7 |
locator |
7 |
group_1_arm_7 |
support_groups |
7 |
group_1_arm_7 |
locator |
7 |
group_2_arm_7 |
support_groups |
7 |
group_2_arm_7 |
locator |
7 |
group_3_arm_7 |
support_groups |
7 |
group_3_arm_7 |
locator |
7 |
text_message_1_arm_7 |
text_messages |
7 |
text_message_1_arm_7 |
locator |
7 |
text_message_2_arm_7 |
text_messages |
7 |
text_message_2_arm_7 |
locator |
8 |
core_arm_8 |
locator |
8 |
core_arm_8 |
core_component_form |
8 |
core_arm_8 |
randomization_check_form |
8 |
brief_video_arm_8 |
brief_video |
8 |
brief_video_arm_8 |
locator |
8 |
text_message_1_arm_8 |
text_messages |
8 |
text_message_1_arm_8 |
locator |
8 |
text_message_2_arm_8 |
text_messages |
8 |
text_message_2_arm_8 |
locator |
9 |
core_arm_9 |
locator |
9 |
core_arm_9 |
core_component_form |
9 |
core_arm_9 |
randomization_check_form |
9 |
brief_video_arm_9 |
brief_video |
9 |
brief_video_arm_9 |
locator |
9 |
group_1_arm_9 |
support_groups |
9 |
group_1_arm_9 |
locator |
9 |
group_2_arm_9 |
support_groups |
9 |
group_2_arm_9 |
locator |
9 |
group_3_arm_9 |
support_groups |
9 |
group_3_arm_9 |
locator |
10 |
core_arm_10 |
locator |
10 |
core_arm_10 |
core_component_form |
10 |
core_arm_10 |
randomization_check_form |
10 |
brief_video_arm_10 |
brief_video |
10 |
brief_video_arm_10 |
locator |
Moving Through Activities for One Participant
With the example project, you can add new records to move through activities for individual participants and plan workflows for your own MOST study.
The only event in the screening arm, a brief eligibility interview, is common to all potential study participants. There could be additional events in the screening arm for things like results of biological tests and documentation of a status related to eligibility criteria. The goal of the screening arm is to assess various aspects of eligibility criteria, documenting who is eligible and, if not eligible, the reasons why. Only potential participants who are eligible proceed to the main study. Informed consent may be obtained from eligible individuals near the end of the screening arm.
After screening may be a good time to generate a schedule for an eligible and enrolled participant. Schedule generation is arm-specific. The schedule can be modified over time to accommodate rescheduling and no-shows.
Record-specific scheduled events appear on the project calendar, along with the record unique identifier, and this is a good way to know what activities are coming up.
The first event in the assessment arm is a baseline interview. Other events in the assessment arm include one or more follow-up interviews and randomization.
Once the randomization module has been completely set up, the randomization form will show a button to push for assignment.
A random assignment to a study condition is made on the assessment arm, and that result needs to be carefully handed off to the correct condition-specific arm. The Randomization Check Form is a safety measure to ensure the condition-specific arm the participant is being added to matches the condition assigned by the randomization module. If a mistake has been made and there is not a match, project staff can cancel/back out, recheck the correct condition for the participant, and then add them to that arm.
A participant assigned to the tuna condition of the example project will experience the Core intervention, the detailed video, three support group meetings, and two text messages. The Core event can be used to deliver any information or intervention content that will be common to all participants.
Scheduling of condition-specific events can start once random assignment has been completed and checked.
One follow-up is timed to occur soon after all intervention components should have been received.
A second and final follow-up is timed to occur 150 days after baseline.
In the example project, nearly every event prompts for a new collection of locator. This may be overkill. You may not want/need locator information for potential participants merely being screened. For your own MOST study, consider when locator should be collected for the first time, and when it should be updated/repeated.