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临床试验/NCT07475338
NCT07475338尚未招募不适用

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

SKEZI1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
500
试验地点
1
主要终点
Completion rate

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Participants are unaware that the trial was being conducted, and the researchers and data analysts were blind to participants' assigned groups.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • - 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)

研究组 & 干预措施

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).

干预措施: Storytelling questionnaire (Other)

Neutral

No Intervention

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

结局指标

主要结局

Completion rate

时间窗: 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)

次要结局

  • 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)

研究者

发起方
SKEZI
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Jean-Philippe BERTOCCHIO

CEO, PhD, MD

SKEZI

研究点 (1)

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