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临床试验/NCT07473466
NCT07473466已完成不适用

Le French Gut: Randomized-Controlled Trial to Evaluate Reminder Strategies (Emails and Text Messages) to Increase Participation in the Le French Gut E-cohort

SKEZI1 个研究点 分布在 1 个国家目标入组 20,487 人开始时间: 2024年11月7日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20,487
试验地点
1
主要终点
Completion rate

研究概览

简要总结

This study is a randomized controlled trial nested in the "Le French Gut" e-cohort aiming to test the efficacy of 4 reminder strategies (emails and/or SMS with standard and/or institutional wording) in increasing participation of inactive volunteers.

This trial is led in collaboration between the "Le French Gut" project and SKEZI, a DeepTech start-up which markets the data collection solution (SKEZIA online platform) for the "Le French Gut" project and carries out the InnoPRO program, aimed at generating new knowledge in the field of e-cohorts.

详细描述

The "Le French Gut" project (NCT05758961) is an ongoing online research cohort aiming to collect faecal samples and associated nutritional and clinical data to better understand the observed heterogeneity between gut microbiome of healthy subjects, its connections with the diet and lifestyle, but also changes in gut microbiota associated with diseases (diabetes, obesity, allergies, cancer, Parkinson, Alzheimer…). Le French Gut is initiated by MetaGenoPolis-INRAE, supported by INRAE with Prof. R. Benamouzig, (AP-HP) as principal investigator of the project.

When participants first register to participate in the cohort, they must complete a short "About You" ("A propos de vous") questionnaire before they can receive any study kits and be considered as active participants in the research. In October 2024, almost half of the ~43,000 individuals who have created an account never finish this first questionnaire needed to validate their participation in the cohort.

Purpose of the study This study will test which type of reminder works best for encouraging those inactive volunteers to return to the platform and complete the missing questionnaire.

How the study will be done

All eligible volunteers (i.e. people who registered on the online platform and provided a valid e mail address or mobile number but have not yet finished completing the "A propos de vous" questionnaire) will be randomly assigned to one of four groups:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Participants were unaware that the trial was being conducted, and the researchers and data analysts were blind to participants' assigned groups.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being registered on the "Le French Gut" platform but not active participant (e.i. eligibility questionnaire not completed, "Le French Gut" consent not validated, "A propos de vous" questionnaire not completed)
  • Having provided a valid email address and/or mobile-phone number

排除标准

  • Completed "A propos de vous" questionnaire before the first reminder
  • Being non eligible to the "Le French Gut" cohort (eligibility to "Le Fench Gut" cohort: being over 18 years-old and living in France)

研究组 & 干预措施

standard emails only

Experimental

Standard, semi-formal worded email inviting participants to complete the online "A propos de vous" (personal information) questionnaire in order to validate their participation in the "Le French Gut" cohort.

干预措施: 3 standard email reminders (Other)

institutional emails only

Experimental

Institutional, formal-worded email, signed by the study coordinator, inviting participants to complete the online "A propos de vous" (personal information) questionnaire in order to validate their participation in the "Le French Gut" cohort.

干预措施: 3 institutional email reminders (Other)

SMS only

Experimental

Short text message inviting participants to complete the online "A propos de vous" (personal information) questionnaire in order to validate their participation in the "Le French Gut" cohort.

干预措施: 3 SMS reminders (Other)

Combined reminders

Experimental

Combined sequence of reminders: first, the standard email; second, the SMS; third, the institutional email. The contents of the reminders are similar to those of the three other parallel groups inviting participants to complete the online "A propos de vous" (personal information) questionnaire in order to validate their participation in the "Le French Gut" cohort.

干预措施: Combined reminders (Other)

结局指标

主要结局

Completion rate

时间窗: 30 days post-reminder

Proportion of participants who complete the "A propos de vous" questionnaire within 30 days after the last reminder, calculated as number of participants who fully completed the questionnaire divided by total number of participants included in the study (or arm)

次要结局

  • Completion time(30 days post-reminder)
  • Login rate(30 days post-reminder)
  • Login time(30 days post-reminder)

研究者

发起方
SKEZI
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Jean-Philippe BERTOCCHIO

CEO, PhD, MD

SKEZI

研究点 (1)

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