Finding Immune Nascent Type 1 Diabetes (FIND T1D)
Finding Immune Nascent Type 1 Diabetes (FIND T1D)
The goal of this clinical trial is to understand how many individuals who previously participated in the Indiana Biobank will return a type 1 diabetes home screening kit based upon different methods of recruitment communication. The main question it aims to answer is:
What form of recruitment communication is most effective for completing a type 1diabetes home screening kit?
Researchers will compare two types of recruitment contact: email and mail based communication (low-touch) versus phone contact and follow-up by a research team member (high-touch).
Participants will be contacted either via email/mail or by phone and asked if they want to complete a type 1 diabetes home screening kit.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Maureen Mullen Montagano
- 电话号码：317-274-7677
- 邮箱：findt1d@iu.edu
研究联系人备份
- 姓名：Adarsh Viswanath
- 电话号码：317-278-5033
- 邮箱：findt1d@iu.edu
学习地点
-
-
Indiana
-
Indianapolis、Indiana、美国、46202
- 招聘中
- Indiana University School of Medicine
-
首席研究员：
- Emily K Sims, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Participant must be in Indiana Biobank
- Participant must be able to provide consent
- Ages 1-99 including pregnant women
Exclusion Criteria:
- Refusal to sign informed consent for home screening is exclusionary for the home screening portion of the study
- While other medical conditions are allowable prior diabetes diagnosis is exclusionary for home autoantibody screening
学习计划
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Low-touch intervention
|
Recruitment through email and mail |
|
实验性的：High-touch intervention
|
Recruitment through phone call |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rates of Returned Home Screening Kits
大体时间：From enrollment to the end of study at 3 years.
|
The number of returned screening kits versus the number that were not returned by consented participants. |
From enrollment to the end of study at 3 years.
|
|
Rates of Consent
大体时间：From enrollment to the end of study at 3 years.
|
The number of participants who consent versus the number of participants who do not consent. |
From enrollment to the end of study at 3 years.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percent of Kits with Adequate Blood Volume
大体时间：From enrollment to the end of study at 3 years.
|
From enrollment to the end of study at 3 years.
|
|
|
Rates of Returned Home Screening Kits
大体时间：From enrollment to the end of study at 3 years
|
The number of returned screening kits versus the number that were not returned by consented participants. Some of which will receive information that they may be at increased risk of type 1 diabetes. |
From enrollment to the end of study at 3 years
|
|
Rates of Consent
大体时间：From enrollment to the end of study at 3 years.
|
The number of participants who consent versus the number of participants who do not consent. Some participants will receive information that they may be at increased risk of type 1 diabetes. |
From enrollment to the end of study at 3 years.
|
合作者和调查者
合作者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 31119
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Participant results will be shared as summary data but because participants declining consent have not agreed we will not provide individual level data.
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研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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