Endoexpedition - Use of a Serious Game to Deliver Patient Information and Decision Aid for Individuals With Endometriosis: A National Multicenter Randomized-controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Patient satisfaction with information received
研究概览
简要总结
Endometriosis is a chronic disease that can negatively affect quality of life, daily functioning, fertility, and psychological well-being. Adequate patient education is important for informed decision-making and active participation in care, but traditional written information may not meet the needs of all patients.
This national multicenter randomized controlled trial will evaluate whether a serious game can improve patient satisfaction when delivering information about endometriosis and its treatment options compared with standard written information. Adults with suspected or confirmed endometriosis will be randomized to receive either game-based educational material (Endoexpedition) or traditional written information. The study will assess patient satisfaction, knowledge acquisition, engagement, knowledge retention, and user interaction with the educational platform. A total of 250 participants will be included and followed for up to one year.
详细描述
Endometriosis is a chronic inflammatory disease affecting approximately 10% of women of reproductive age and is commonly associated with pelvic pain, dysmenorrhea, dyspareunia, reduced quality of life, and infertility. Despite the high prevalence and substantial impact on physical and psychological well-being, diagnosis is often delayed for several years. Adequate patient education is essential for informed decision-making, treatment adherence, and patient empowerment. However, patient information is traditionally delivered through written materials, which may not meet the needs and learning preferences of all individuals.
Interactive educational technologies, including serious games, have emerged as promising tools for patient education. Serious games combine educational content with engaging and interactive elements that may improve motivation, knowledge acquisition, and long-term retention of information. Previous research in other chronic diseases suggests that game-based learning can improve patient engagement and self-management, but no randomized controlled trial has evaluated this approach in individuals with endometriosis.
The EndoExpedition trial is a national multicenter, open-label, randomized controlled trial conducted at the four Swedish National Highly Specialized Care (NHV) centers for advanced endometriosis. Adults with suspected or confirmed endometriosis will be randomized in a 1:1 ratio to receive either standard written patient information or access to EndoExpedition, a serious game specifically developed to provide evidence-based information about endometriosis and its treatment options.
The serious game is based on current international guidelines and covers anatomy, pathophysiology, symptoms, diagnostic procedures, hormonal treatment, surgical treatment, and common misconceptions regarding endometriosis. Educational content is delivered through interactive storytelling, visual novel elements, puzzles, three-dimensional models, and feedback mechanisms designed to promote meaningful learning and user engagement.
The primary objective is to determine whether delivery of patient information through a serious game improves patient satisfaction compared with standard written information. Patient satisfaction will be measured using the validated Quality from the Patient's Perspective (QPP) questionnaire immediately after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older.
- •Suspected or confirmed endometriosis.
- •Able to understand written Swedish.
- •Able to provide informed consent.
排除标准
- •Inability to independently complete the Swedish-language educational game.
- •Unwillingness or inability to provide informed consent.
研究组 & 干预措施
EndoExpedition Serious game
Participants receive patient information about endometriosis and available treatment options through EndoExpedition, a serious game specifically developed for patient education. The game includes interactive learning modules covering anatomy, pathophysiology, symptoms, diagnostic procedures, hormonal treatment, surgical treatment, and common misconceptions regarding endometriosis.
干预措施: EndoExpedtion Serious game (Behavioral)
Standard Written Information
Participants receive standardized written patient information about endometriosis and available treatment options. The information corresponds to the educational content routinely provided at the participating National Highly Specialized Care (NHV) centers.
干预措施: Standard Written Patient Information (Behavioral)
结局指标
主要结局
Patient satisfaction with information received
时间窗: Day 1 (immediately after completion of the educational intervention serious game or written information)
Patient satisfaction measured using the Quality from the Patient's Perspective (QPP) questionnaire. The primary endpoint is the Perceived Reality (PR) score for the single global satisfaction item of the validated Quality from the Patient's Perspective (QPP) questionnaire: "Overall, I am satisfied with the information I have received." Responses are rated on a 4-point Likert scale ranging from 1 (do not agree at all) to 4 (completely agree), where higher scores indicate greater satisfaction. Only this single QPP item is used for the primary outcome analysis.
次要结局
- Knowledge about endometriosis and treatment options(Day 1. Immediately after receiving the educational intervention)
- Knowledge retention(12 months after educational intervention)
- Perceived meaningfulness of the educational format(Day 1. Immediately after receiving the educational intervention)
- Total active game time(Day 1. During game use from randomization until completion of the intervention)
- Active time per game chapter(Day 1. During game use from randomization until completion of the intervention.)
- Number of game chapters completed(Day 1. During game use from randomization until completion of the intervention)
- Game chapters accessed(Day 1. During game use from randomization until completion of the intervention)
研究者
Malin Brunes
Principal Investigator
Karolinska Institutet
