General Population (no Specific Condition or Disease)PEGASYSNCT07475338
Effect of Storytelling on Questionnaire Completion and Quality of Collected Data in an E-Cohort
A study testing Storytelling questionnaire in people with General Population (no Specific Condition or Disease), run by SKEZI at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- General Population (no Specific Condition or Disease)
- What is being tested?
- Storytelling questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2026to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
SKEZI
Paris
Jean-Philippe Bertocchio, MD, PhD, +33649174259, jean-philippe.bertocchio@skezi.eu
About this study
Official title: PEGASYS (Projet d'Expérimentation Sur la Gamification et Analyse du StorYtelling Sur SKEZIA): Randomized Controlled Trial Assessing the Effect of Storytelling on Questionnaire Completion and Data Quality Within the E-Cohort SKETHIS
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.
Read the detailed description
SKETHIS is a national e-cohort that serves as an observatory of health-related quality of life in France. Launched in September 2023 by SKEZI, the cohort is built as a secure health-data warehouse hosted on the SKEZIA data-collection solution. While its primary aim is to monitor health-related quality of life, its trajectories and determinants, SKETHIS is also the opportunity for SKEZI to carry out its InnoPRO program, an initiative dedicated to generate new knowledge in the field of e-cohorts.
Gamification, i.e. the integration of game-design elements, such as points, levels, or badges into non-game contexts, has been shown to increase usage, prolong retention and improve adherence to e-health services. Storytelling is a specific gamification tool that employs narrative techniques (voices, story characters, suspense, etc.) to structure a coherent, accessible and engaging participants' experience.
Improving and maintaining participant engagement is a major challenge for large-scale e-cohorts. Although gamification and storytelling have been empirically used to boost participation, the effect of storytelling on self-administered patient reported outcome questionnaires has not been evaluated in a rigorously designed randomized clinical trial.
Purpose of the study To determine whether adding a modest, narrative-driven storytelling introduction to a Patient-Reported Outcome questionnaire increases questionnaire completion without compromising data quality.
How the study will be done
This study is a parallel-group randomized controlled trial nested within SKETHIS. All eligible SKETHIS participants (i.e. participants who have completed the first questionnaire and socio-demographic questionnaire) will be randomly assigned to one of two groups:
- Intervention: Patient-Reported Outcome Questionnaire with storytelling
- Control: Patient-Reported Outcome Questionnaire without storytelling The same Patient-Reported Outcome questionnaire (French version of the Global Physical Activity Questionnaire [GPAQ]) will be used in both groups (with the same questions). The introduction page and design of the questionnaire will differ between the two groups: short narrative with minimal visual design (color palette, icons, illustrations) for the intervention group; neutral (plain text, no narrative, no visual embellishment) for the control group.
Questions the study will answer
- Does the storytelling increase completion rate of the questionnaire (proportion of participants who fully completed the questionnaire) within 30 days, compared to the neutral (control) version?
- Does the storytelling improve participants' self reported satisfaction (Net Promoter Score) after questionnaire completion?
- Does the storytelling reduce the drop out (abandonment) rate - i.e., the proportion of participants who start the questionnaire but do not finish it - within 30 days of receipt?
- Does the storytelling affect the quality of the data collected?
Hypothesis Investigators hypothesized that the integration of storytelling in self-reported Patient-Reported Outcome questionnaire will increase completion rates and participants' satisfaction, without negatively impacting data quality.
Why this matters Finding ways to increase engagement in SKETHIS, and other online cohorts, will help improving the quantity and quality of the data that can be used for future health research. The results will be shared in a peer reviewed scientific article and could guide the design of future e cohort studies worldwide.
- Being tested
- Storytelling questionnaire
- Keywords
- e-cohort, response rate, completion, data quality, gamification, storytelling, RCT
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Storytelling questionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Storytelling questionnaire |
| Neutral | No intervention | Self-administrated Patient-Reported Outcome questionnaire (Global Physical Activity Questionnaire) presented as is (no narrative, no visual embellishment). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days after sending the questionnaire
Secondary outcomes (3)
Completion rate for non-mandatory questions
Number of participants who answered additional non-mandatory questions divided by number of participants who validated the questionnaire
Measured: 30 days after sending the questionnaire
Ratio number of answered questions over time spent on the questionnaire
Number of answered questions divided by time spent on the questionnaire
Measured: 30 days after sending the questionnaire
Internal validity of the Patient-Reported Outcome questionnaire
Cronbach alpha and "floor and ceiling effects" for the Patient Reported Outcome questionnaire (Global Physical Activity Questionnaire)
Measured: 30 days after sending the questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Population (no Specific Condition or Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SKEZI
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Jean-Philippe BERTOCCHIO, SKEZI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475338
- Sponsor's protocol ID
- SKETHIS-INNOPRO-001
- Acronym
- PEGASYS
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEGASYS (Projet d'Expérimentation Sur la Gamification et Analyse du StorYtelling Sur SKEZIA): Randomized Controlled Trial Assessing the Effect of Storytelling on Questionnaire Completion and Data Quality Within the E-Cohort SKETHIS
- ClinicalTrials.gov ID
- NCT07475338
- Acronym / sponsor ID
- PEGASYS / SKETHIS-INNOPRO-001
- Keywords
- e-cohort, response rate, completion, data quality, gamification, storytelling, RCT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- SKEZIIndustry (pharma, biotech, devices)
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
SKETHIS is a national e-cohort that serves as an observatory of health-related quality of life in France. Launched in September 2023 by SKEZI, the cohort is built as a secure health-data warehouse hosted on the SKEZIA data-collection solution. While its primary aim is to monitor health-related quality of life, its trajectories and determinants, SKETHIS is also the opportunity for SKEZI to carry out its InnoPRO program, an initiative dedicated to generate new knowledge in the field of e-cohorts.
Gamification, i.e. the integration of game-design elements, such as points, levels, or badges into non-game contexts, has been shown to increase usage, prolong retention and improve adherence to e-health services. Storytelling is a specific gamification tool that employs narrative techniques (voices, story characters, suspense, etc.) to structure a coherent, accessible and engaging participants' experience.
Improving and maintaining participant engagement is a major challenge for large-scale e-cohorts. Although gamification and storytelling have been empirically used to boost participation, the effect of storytelling on self-administered patient reported outcome questionnaires has not been evaluated in a rigorously designed randomized clinical trial.
Purpose of the study To determine whether adding a modest, narrative-driven storytelling introduction to a Patient-Reported Outcome questionnaire increases questionnaire completion without compromising data quality.
How the study will be done
This study is a parallel-group randomized controlled trial nested within SKETHIS. All eligible SKETHIS participants (i.e. participants who have completed the first questionnaire and socio-demographic questionnaire) will be randomly assigned to one of two groups:
- Intervention: Patient-Reported Outcome Questionnaire with storytelling
- Control: Patient-Reported Outcome Questionnaire without storytelling The same Patient-Reported Outcome questionnaire (French version of the Global Physical Activity Questionnaire [GPAQ]) will be used in both groups (with the same questions). The introduction page and design of the questionnaire will differ between the two groups: short narrative with minimal visual design (color palette, icons, illustrations) for the intervention group; neutral (plain text, no narrative, no visual embellishment) for the control group.
Questions the study will answer
- Does the storytelling increase completion rate of the questionnaire (proportion of participants who fully completed the questionnaire) within 30 days, compared to the neutral (control) version?
- Does the storytelling improve participants' self reported satisfaction (Net Promoter Score) after questionnaire completion?
- Does the storytelling reduce the drop out (abandonment) rate - i.e., the proportion of participants who start the questionnaire but do not finish it - within 30 days of receipt?
- Does the storytelling affect the quality of the data collected?
Hypothesis Investigators hypothesized that the integration of storytelling in self-reported Patient-Reported Outcome questionnaire will increase completion rates and participants' satisfaction, without negatively impacting data quality.
Why this matters Finding ways to increase engagement in SKETHIS, and other online cohorts, will help improving the quantity and quality of the data that can be used for future health research. The results will be shared in a peer reviewed scientific article and could guide the design of future e cohort studies worldwide.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Storytelling | Experimental | Other: Storytelling questionnaireSelf-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). |
| Neutral | No intervention | –Self-administrated Patient-Reported Outcome questionnaire (Global Physical Activity Questionnaire) presented as is (no narrative, no visual embellishment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Storytelling questionnaireIn 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. | Other | Storytelling |
Primary outcome
Completion rate
Time frame: 30 days after sending the questionnaire
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)
3 secondary outcomes
Completion rate for non-mandatory questions
Time frame: 30 days after sending the questionnaire
Ratio number of answered questions over time spent on the questionnaire
Time frame: 30 days after sending the questionnaire
Internal validity of the Patient-Reported Outcome questionnaire
Time frame: 30 days after sending the questionnaire
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Storytelling questionnaire in people with General Population (no Specific Condition or Disease), run by SKEZI at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Philippe Bertocchio, MD, PhD (+33649174259, jean-philippe.bertocchio@skezi.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion rate (time frame: 30 days after sending the questionnaire). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.