Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Questions the study will answer
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Neutral | No Intervention | Self-administrated Patient-Reported Outcome questionnaire (Global Physical Activity Questionnaire) presented as is (no narrative, no visual embellishment). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Storytelling questionnaire | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Completion rate for non-mandatory questions | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Global Physical Activity Questionnaire (GPAQ) Score | Score for level of physical activity calculated as per the WHO GPAQ questionnaire guideline | 30 days after sending the questionnaire |
| Participants' satisfaction |
Inclusion Criteria:
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)
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Philippe Bertocchio, MD, PhD | Contact | +33649174259 | jean-philippe.bertocchio@skezi.eu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SKEZI | Paris | France |
|
Not provided
| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
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)
Not provided
Not provided
Participants are unaware that the trial was being conducted, and the researchers and data analysts were blind to participants' assigned groups.
|
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 | Cronbach alpha and "floor and ceiling effects" for the Patient Reported Outcome questionnaire (Global Physical Activity Questionnaire) | 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 | 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 | 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 | Number of non completed questionnaires divided by number of started questionnaires | 30 days after sending the questionnaire |