Ecological Momentary Assessment to Explore Fatigue, Pain, Sleep, Mood and Physical Activity Levels in Patients With Inflammatory Rheumatic Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility of a 14-day smartphone EMA protocol combined with actigraphy
研究概览
简要总结
Chronic inflammatory rheumatic diseases (IRDs), such as rheumatoid arthritis and spondyloarthritis, can cause pain, fatigue, and mobility issues, significantly impacting patients' quality of life. Physical activity is an important part of managing these conditions, as it helps reduce pain, maintain mobility, and prevent complications. However, many patients struggle to stay active due to pain and fatigue. A better understanding of these challenges could lead to improved support and interventions.
This study explores a new way to monitor the daily experiences of patients with IRDs using Ecological Momentary Assessment (EMA), a method that collects real-time data through a mobile app. The study will also use actimeters-wearable devices that track physical activity. Over 14 days, participants will answer short surveys on their phones and wear an actimeter to provide insights into how fatigue, pain, mood, and physical activity levels change throughout the day.
Before this approach is implemented in a larger study, its practicality and acceptability for patients must be evaluated. This pilot study will assess whether participants find the mobile app and actimeter easy to use, how often surveys are completed, and whether frequent reminders affect participants' willingness to continue. The study will also examine the immediate and delayed effects of different symptoms on physical activity and explore factors that influence participant engagement with the protocol.
By identifying potential barriers and solutions, this research will help refine future studies and improve methods for monitoring and supporting individuals with IRDs in staying active while managing symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years) with a confirmed diagnosis of CIRDs, including RA or SpA, established by a rheumatologist, are eligible for inclusion.
- •Adults able to understand and consent to the study protocol,
- •Adults affiliated with a social security system
- •Adults that have access to a digital device with internet access (e.g., smartphone or tablet).
- •Non-inclusion Criteria:
- •Insufficient proficiency in the French language
- •Legal incapacity or deprivation of liberty
- •Major cognitive impairment incompatible with repeated questionnaire completion (e.g., Alzheimer's disease)
- •Pregnant or breastfeeding women
- •Individuals with a history of alcohol or substance abuse, or severe psychiatric disorders that could affect adherence to the protocol or the reliability of collected data, are also excluded.
排除标准
- 未提供
结局指标
主要结局
Feasibility of a 14-day smartphone EMA protocol combined with actigraphy
时间窗: Day 1 to Day 14 after enrollment
Feasibility will be quantified on five pre-specified indicators: (1) attrition rates; measured by the number of participants who withdrew from the study, (2) the number and percentage of data collected from EMA surveys relative to the number of potential assessments, (3) the percentage of surveys that a participant started to complete, relative to the number of potential assessments, (4) time elapsed between the prompt and the start of the response to the survey, (5) adherence to actigraphy (the threshold is at least 21 hours of wear time over 24 hours, for 14 days).
Acceptability of a 14-day EMA protocol combined with actigraphy delivered via a mobile application
时间窗: Day 1 to Day 14 after enrollment
Acceptability will be assessed at follow-up using a structured questionnaire and semi-structured interviews. The questionnaire will evaluate participant satisfaction, perceived relevance, ease of use, and daily burden associated with EMA and actigraphy. Each item will be rated on a five-point Likert scale (1 = strongly disagree to 5 = strongly agree). Acceptability at the item level will be defined as ≥70% agreement on positively worded items and ≤30% agreement on negatively worded items. A score ≥3/5 will indicate acceptable validation of an item. In addition, semi-structured interviews will be conducted to explore participant experiences; with consent, sessions will be audio-recorded, transcribed in a non-verbatim format, and analyzed using content analysis to identify recurring themes.
次要结局
- Immediate and Lagged Effects on Physical Activity(Day 1 to Day 14 after enrollment)
- Immediate and Lagged Effects of Determinants on Physical Activity(Day 1 to Day 14 after enrollment)
- Adherence and Acceptability of Two Actigraph Devices(Day 1 to Day 14 after enrollment)
- Patient-Perceived Acceptability(Day 1 to Day 14 after enrollment)