- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07475338
Effect of Storytelling on Questionnaire Completion and Quality of Collected Data in an E-Cohort (PEGASYS)
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jean-Philippe Bertocchio, MD, PhD
- Phone Number: +33649174259
- Email: jean-philippe.bertocchio@skezi.eu
Study Locations
-
-
-
Paris, France
- SKEZI
-
Contact:
- Jean-Philippe Bertocchio, MD, PhD
- Phone Number: +33649174259
- Email: jean-philippe.bertocchio@skezi.eu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Storytelling
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).
|
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.
|
|
No Intervention: Neutral
Self-administrated Patient-Reported Outcome questionnaire (Global Physical Activity Questionnaire) presented as is (no narrative, no visual embellishment).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
30 days after sending the questionnaire
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Completion rate for non-mandatory questions
Time Frame: 30 days after sending the questionnaire
|
Number of participants who answered additional non-mandatory questions divided by number of participants who validated the questionnaire
|
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
|
Number of answered questions divided by time spent on the questionnaire
|
30 days after sending the questionnaire
|
|
Internal validity of the Patient-Reported Outcome questionnaire
Time Frame: 30 days after sending the questionnaire
|
Cronbach alpha and "floor and ceiling effects" for the Patient Reported Outcome questionnaire (Global Physical Activity Questionnaire)
|
30 days after sending the questionnaire
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Global Physical Activity Questionnaire (GPAQ) Score
Time Frame: 30 days after sending the questionnaire
|
Score for level of physical activity calculated as per the WHO GPAQ questionnaire guideline
|
30 days after sending the questionnaire
|
|
Participants' satisfaction
Time Frame: 30 days after sending the questionnaire
|
Net promoter score: "On a scale of 0 to 5, how likely are you to recommend participation to SKETHIS to a friend or colleague?"
|
30 days after sending the questionnaire
|
|
Participants' satisfaction open-ended question
Time Frame: 30 days after sending the questionnaire
|
Number of dimensions identified by grounded theory analysis for the responses to the open-ended question on satisfaction: "What would you change to make the questionnaire more enjoyable to complete?"
|
30 days after sending the questionnaire
|
|
Perceived scientificity of the questionnaire
Time Frame: 30 days after sending the questionnaire
|
Score for the question: "On a scale of 0 to 5, how serious do you take this scientific questionnaire?"
|
30 days after sending the questionnaire
|
|
Abondon rate
Time Frame: 30 days after sending the questionnaire
|
Number of non completed questionnaires divided by number of started questionnaires
|
30 days after sending the questionnaire
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SKETHIS-INNOPRO-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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