Pilot Study for the Evaluation of the More Stamina Mobile Application for Fatigue Management in Persons With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- App Engagement Patterns
研究概览
简要总结
The overall study aims are to explore the feasibility, acceptability, and usability of More Stamina, a mobile app for fatigue self-management for persons with MS.
详细描述
Multiple sclerosis (MS) is one of the world's most common neurologic disorders of the young adults leading to severe disability. Fatigue is one of most common symptoms that persons with MS experience, having significant impact on their quality of life and limiting their activity levels. Self-management strategies are used to support them in the care of their health. Mobile health (mHealth) solutions are a way to offer persons with chronic conditions tools to successfully manage their symptoms and problems. User-centered design (UCD) is a design philosophy that proposes placing end-users' needs and characteristics in the center of software design and development and involving users early in the different phases of the software life cycle. More Stamina is an mHealth solution created following UCD principles to help persons with MS manage their fatigue.
A mixed methods study was used to assess the feasibility, acceptability, and usability of More Stamina. The study took place between January and March of 2023 in Finland. A longitudinal cohort study took take place, along with think-aloud protocols, open-ended interviews and short answer questionnaires. The study enrolled 20 persons with MS that met the criteria who utilized the More Stamina solution for 60 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be over 18 years old;
- •have a confirmed MS diagnosis (including secondary, relapsing and progressive MS) for at least 1 year,
- •have none to moderate physical disability (EDSS < 6.5) at the time of recruiting;
- •no major cognitive or haptile impairment influencing the ability to use the app;
- •own a compatible smartphone device;
排除标准
- •Refusal to participate or the informed consent process;
- •Objective cognitive impairment that hinders the use of mobile applications;
- •Physical or cognitive impossibility to use the visual interface of mobile applications;
- •difficulties in access or availability for full attendance at the 3 encounters of the study.
结局指标
主要结局
App Engagement Patterns
时间窗: Over the 60-day study period.
Participants' engagement with the "More Stamina" app, categorized into power, regular, and light users based on daily session averages. Engagement analyzed through session frequency, timing, and activity types.
Qualitative Insights into Usability and Barriers
时间窗: Day 1, Day 15, Day 30, and Day 60.
Insights into usability challenges and facilitators were gathered using think-aloud protocols and semi-structured interviews. Common themes, including cognitive load, technical issues, and emotional responses, were analyzed.
次要结局
- Association Between User Categories and Fatigue Severity Scores(Over the 60-day study period.)
- Association Between User Categories and Health-Related Quality of Life Scores(Over the 60-day study period.)
研究者
Guido Giunti
Senior Researcher
University of Oulu