Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-25 @ 1:14 PM
NCT ID:
NCT03119259
Description:
Adverse events among caregiver participants were collected and reported separately from patient participants
Frequency Threshold:
0
Time Frame:
6 months from enrollment
Study:
NCT03119259
Study Brief:
Technology Intervention to Support Caregiving for Alzheimer's Disease (I-CARE)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Usual Care - Caregivers | Informal caregivers randomized to the comparison group receive usual care for Alzheimer's disease and related dementia (ADRD) from their health system, either Eskenazi Health or Indiana University (IU) Health. The standard of ADRD care at Eskenazi Health is the ABC Clinical Program. The goal of the ABC Clinical Program is to help primary care physicians achieve the standard of care in the diagnosis, evaluation and management of patients with ADRD. It is delivered by an interdisciplinary team led by a care coordinator. The informal caregiver of the person living is also enrolled in the program and caregiver burden is assessed and managed. The ABC team collects all relevant data and formulates an individualized care plan in collaboration with the informal caregiver. The care coordinator communicates the team's recommendations to the primary care physician and finalizes a collaborative plan of action. During the next year, the ABC team uses face-to-face and telephone interactions with the patient and caregiver to monitor and modify implementation of the care plan. The standard of ADRD care at IU Health is Primary Care visits. The goal of Primary Care at IU Health is to provide preventive care services to their patients. Older adults are assessed for ADRD during clinic visits and referred to brain care specialty as necessary. | 0 | None | 0 | 27 | 0 | 27 | View |
| Brain CareNotes (BCN) Software - Caregivers | Informal caregivers randomized to the intervention group continue to receive usual care for ADRD at Eskenazi Health or IU Health, and additionally receive the BCN software. BCN is installed on either the caregiver's personal mobile device or a device provided by the study. A research assistant orients participants to the device, provides training on the BCN software, and provides technical support and reminders. BCN is a mobile application (app) for informal caregivers of patients with ADRD. The BCN app delivers the following behavioral support: 1. 24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or "Notes"; 2. Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores; 3. Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others. | 0 | None | 0 | 26 | 0 | 26 | View |
| Usual Care - Patients | Patients randomized to the comparison group receive usual care for Alzheimer's disease and related dementia (ADRD) from their health system, either Eskenazi Health or Indiana University (IU) Health. The standard of ADRD care at Eskenazi Health is the ABC Clinical Program. The goal of the ABC Clinical Program is to help primary care physicians achieve the standard of care in the diagnosis, evaluation and management of patients with ADRD. It is delivered by an interdisciplinary team led by a care coordinator. The informal caregiver of the person living is also enrolled in the program and caregiver burden is assessed and managed. The ABC team collects all relevant data and formulates an individualized care plan in collaboration with the informal caregiver. The care coordinator communicates the team's recommendations to the primary care physician and finalizes a collaborative plan of action. During the next year, the ABC team uses face-to-face and telephone interactions with the patient and caregiver to monitor and modify implementation of the care plan. The standard of ADRD care at IU Health is Primary Care visits. The goal of Primary Care at IU Health is to provide preventive care services to their patients. Older adults are assessed for ADRD during clinic visits and referred to brain care specialty as necessary. | 1 | None | 0 | 27 | 0 | 27 | View |
| Brain CareNotes (BCN) Software - Patients | Patients randomized to the intervention group continue to receive usual care for ADRD at Eskenazi Health or IU Health, and additionally receive the BCN software. BCN is installed on either the caregiver's personal mobile device or a device provided by the study. A research assistant orients participants to the device, provides training on the BCN software, and provides technical support and reminders. BCN is a mobile application (app) for informal caregivers of patients with ADRD. The BCN app delivers the following behavioral support: 1. 24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or "Notes"; 2. Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores; 3. Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others. | 0 | None | 0 | 26 | 0 | 26 | View |
Serious Events(If Any):
Other Events(If Any):