NCT07475338

Brief Summary

This study is a randomized controlled trial, nested in the SKETHIS e-cohort, aiming to evaluate whether adding a modest, narrative-driven, strorytelling introduction to a Patient-Reported Outcome questionnaire increases completion without compromising data quality. This trial is led by SKEZI, a DeepTech start-up which markets a data collection solution and carries out the InnoPRO program, aimed at generating new knowledge in the field of e-cohorts.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

March 1, 2026

Completed
10 days 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
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 11, 2026

Last Update Submit

March 14, 2026

Conditions

Keywords

e-cohortresponse ratecompletiondata qualitygamificationstorytellingRCT

Outcome Measures

Primary Outcomes (1)

  • Completion rate

    Proportion of participants who complete the Patient-Reported Outcome questionnaire within 30 days after the questionnaire is first sent, calculated as number of participants who fully completed the questionnaire divided by total number of participants included in the study (or arm)

    30 days after sending the questionnaire

Secondary Outcomes (3)

  • Completion rate for non-mandatory questions

    30 days after sending the questionnaire

  • Ratio number of answered questions over time spent on the questionnaire

    30 days after sending the questionnaire

  • Internal validity of the Patient-Reported Outcome questionnaire

    30 days after sending the questionnaire

Other Outcomes (5)

  • Global Physical Activity Questionnaire (GPAQ) Score

    30 days after sending the questionnaire

  • Participants' satisfaction

    30 days after sending the questionnaire

  • Participants' satisfaction open-ended question

    30 days after sending the questionnaire

  • +2 more other outcomes

Study Arms (2)

Storytelling

EXPERIMENTAL

Self-administrated Patient-Reported Outcome questionnaire (Global Physical Activity Questionnaire) enhanced by storytelling with a short narrative introduction and minimal visual design (color palette, icons, illustrations).

Other: Storytelling questionnaire

Neutral

NO INTERVENTION

Self-administrated Patient-Reported Outcome questionnaire (Global Physical Activity Questionnaire) presented as is (no narrative, no visual embellishment).

Interventions

In the context of the SKETHIS e-cohort, participants receive an email inviting them to complete a new online questionnaire regarding their physical activity. Participants are unaware that the experiment is being conducted or that the questionnaire uses storytelling.

Storytelling

Eligibility Criteria

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

You may qualify if:

  • Being a current SKETHIS participant (eligibiliy criteria: being 18 or older, living in France, reading and understanding French, having a digital device with internet access and a valid e-mail address)
  • Having completed the main SKETHIS questionnaire and the socio-demographic information questionnaire
  • Providing consent to participate to the study

You may not qualify if:

  • \- Answering "I am unable to walk out" to the EQ-5D mobility item part of the main SKETHIS questionnaire (cannot complete Global Physical Activity Questionnaire)

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

Central Study Contacts

Jean-Philippe Bertocchio, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants are 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, 2-arm (intervention vs control), 1:1 allocation ratio, stratified by gender (male/female), 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

March 1, 2026

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations