Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
NCT ID:
NCT03823651
Group ID:
EG000
Title:
Patient
Description:
These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Interval training: Patients will be asked to complete up to 3 x 30-minute structured high intensity interval training aerobic exercise sessions/week. For the first session, patients will come to the Duke Center for Living for in person evaluation and training. After the initial training session in person, a subsequent training session will take place at the patient's home via iPad/iPhone videoconference using a device provided to the patient to provide additional support and the opportunity to answer questions. Subsequent sessions will be done independently by patients, but study staff will be available via iPad/iPhone if questions arise.
Psychiatric consult: Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up.
Nutrition/diet evaluation: PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month
Referral to Social Worker: Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up
Deaths Number Affected:
5
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
13
Other Number Affected:
2
Other Number At Risk:
13
Study:
NCT03823651
Results Section:
NCT03823651
Adverse Events Module:
NCT03823651