NCT03938324 · ADVERSE EVENTS
Adverse events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.
- Collection time frame
- Up to 12 months
- Other-event reporting threshold
- 0%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| PiCASO Intervention Group | 0 / 147 | 0 / 147 | 0 / 147 |
| Attention Control Group | 0 / 75 | 0 / 75 | 0 / 75 |
Serious adverse events
Other reported adverse events
Complete source fields
- event Groups
- deaths Num Affected
- 0
- deaths Num At Risk
- 147
- description
- Peer coaching intervention delivered by young adults with a childhood onset chronic condition and trained in coaching curriculum that includes motivational interviewing techniques and the benefits of peer relationships over a shared experience such as a chronic condition. The peer coach supports the AYA to identify their goals and feel a sense of success in making change towards goals within a supportive environment. This process involves goal-setting, development of self-discovery and accountability for changes in health behavior. The peer coach elicits the AYA's vision of optimal health and identifies the AYAs values. As the AYAs identify a vision of wellness and develop goals and action steps to progress towards that vision, the peer coach elicits the AYA's intrinsic motivation and activates skill development in self-advocacy and communication and empowers the AYA to take leadership in managing their condition.
- id
- EG000
- other Num Affected
- 0
- other Num At Risk
- 147
- serious Num Affected
- 0
- serious Num At Risk
- 147
- title
- PiCASO Intervention Group
- deaths Num Affected
- 0
- deaths Num At Risk
- 75
- description
- Over 12 months the attention control group participants will receive a monthly electronic newsletter with educational content about childhood onset chronic condition management and the differences between pediatric and adult health care systems, as well as a monthly phone call from study staff to ensure receipt of the newsletter and to answer questions regarding content, and an opportunity to link them to other resources. If participants report health concerns they will be directed to contact their health care team. Sham Comparator: Attention Control Group: Over 12 months the attention control group participants will receive a monthly electronic newsletter with educational content about childhood onset chronic condition management and the differences between pediatric and adult health care systems, as well as a monthly phone call from study staff to ensure receipt of the newsletter and to answer questions regarding content, and an opportunity to link them to other resources. If participants report health concerns they will be directed to contact their health care team.
- id
- EG001
- other Num Affected
- 0
- other Num At Risk
- 75
- serious Num Affected
- 0
- serious Num At Risk
- 75
- title
- Attention Control Group
- frequency Threshold
- 0
- time Frame
- Up to 12 months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle