NCT07473466

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,487

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2024

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

18 days

First QC Date

March 11, 2026

Last Update Submit

March 14, 2026

Conditions

Keywords

e-cohortreminder strategyresponse rateemail remindertext message remindercompletioninclusion

Outcome Measures

Primary Outcomes (1)

  • Completion rate

    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)

    30 days post-reminder

Secondary Outcomes (3)

  • Completion time

    30 days post-reminder

  • Login rate

    30 days post-reminder

  • Login time

    30 days post-reminder

Other Outcomes (2)

  • Email opening rate

    30 days post-reminder

  • Email click-through rate

    30 days post-reminder

Study Arms (4)

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.

Other: 3 standard email reminders

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.

Other: 3 institutional email reminders

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.

Other: 3 SMS reminders

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.

Other: Combined reminders

Interventions

The same standard email is sent three times to participants, each email spaced 72 hours apart.

standard emails only

The same institutional email is sent three times to participants, each email spaced 72 hours apart.

institutional emails only

The same SMS (brief text message) is sent three times to participants, each SMS spaced 72 hours apart.

SMS only

Three reminders are sent to participants, each reminder spaced 72 hours apart: the first reminder is a standard email, the second reminder is a SMS, the third reminder is a institutional email.

Combined reminders

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SKEZI

Paris, France

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Philippe Bertocchio, MD, PhD

    SKEZI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants were unaware that the trial was being conducted, and the researchers and data analysts were blind to participants' assigned groups.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized, parallel groups, 4-arm, 1:1:1:1 allocation ratio, stratified (by time-since-registration: : ≤ 6 months, 6-12 months, 12-18 months, \>18 months), blinded (data analyst blind to allocation and participants unaware of the trial being conducted)
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CEO, PhD, MD

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 16, 2026

Study Start

November 7, 2024

Primary Completion

November 25, 2024

Study Completion

November 25, 2024

Last Updated

March 17, 2026

Record last verified: 2026-03

Locations