Qualitative Evaluation of Perceived Effects Elicited by AEF0217 in Individuals With Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Aelis Farma
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Overall, how would you describe your experience with the effect of the treatment your son/daughter received during the study?
研究概览
简要总结
Following the AEF0217-102 trial (NCT05748405), which investigated the effects of AEF0217 versus placebo, participants with Down syndrome and their caregivers who took part in the trial are invited to share their perceptions of what they experienced or observed, in an exploratory manner.
This qualitative study collects information through a specific questionnaire developed for this purpose.
详细描述
This is a non-interventional, follow-up, cross-sectional, mixed-methods (qualitative and quantitative) study.
Participants and their caregivers who will be enrolled are those who have received either AEF0217 or placebo and who have completed the previous trial.
They will be contacted prospectively to assess their interest in participating in the study.
They will sign an electronic informed consent form and will receive a link to a questionnaire developed using EU Survey.
Data will be collected at a single time point but may refer retrospectively to past experiences related to the previous trial. Data from all participants and caregivers who complete the questionnaire will be included in the analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants having completed the trial AEF0217-102
- •Being the caregiver of the participant
- •Provided written informed consent (or assent in case of individuals with Down syndrome with no capacity to legally sign the consent)
排除标准
- •1- Not wanting to provide a written informed consent
研究组 & 干预措施
Group AEF0217
Participants who received AEF0217 in the previous trial AEF0217-102
Group Placebo
Participants who received Placebo in the previous trial AEF0217-102
结局指标
主要结局
Overall, how would you describe your experience with the effect of the treatment your son/daughter received during the study?
时间窗: Day 1
* Rating of the global perception of the treatment period (Likert scale). Scale in 5 points (Very positive, Somewhat positive, Neutral, Somewhat negative, Very negative). * Completed by the caregiver
次要结局
未报告次要终点