Ecological momentary assessment of daily patient-reported outcomes and actigraphy-measured physical activity and sleep in patients with rheumatoid arthritis and spondyloarthritis: a study protocol.
This paper presents a protocol for a pilot study assessing the feasibility and acceptability of a 14-day ecological momentary assessment (EMA) protocol combined with actigraphy to monitor patient-reported outcomes and physical activity in individuals with rheumatoid arthritis and spondyloarthritis.
Key Findings
Background
Rheumatoid arthritis and spondyloarthritis are characterised by highly variable symptoms both between and within individuals across days, reflecting the fluctuating nature of disease activity and daily functioning.
Symptoms include pain, fatigue, mood disturbances, sleep problems and reduced quality of life.
This within-person variability motivates the use of ecological momentary assessment rather than traditional cross-sectional or retrospective measurement approaches.
The authors note that capturing the 'dynamic interplay between symptoms and physical activity therefore requires methods that account for day-to-day and moment-to-moment variability.'
Background
Little is currently known about the feasibility and acceptability of EMA protocols combined with actigraphy in individuals with RA and SpA, for whom participant burden and adherence may represent significant challenges.
The authors identify this as a key gap motivating the pilot study.
Feasibility concerns include adherence to EMA prompts and actigraphy wear time.
Acceptability concerns relate to participant burden, particularly relevant for populations with chronic pain and fatigue.
The pilot study is designed specifically to address these unknowns before larger-scale studies.
Methods
The study will recruit 50 adults diagnosed with RA or SpA through rheumatology clinics or via advertisement.
Eligible participants must be smartphone users without cognitive or physical impairments affecting participation.
Participants will complete baseline questionnaires regarding disease activity, quality of life, sleep, pain, fatigue, and affective states.
A remote onboarding session with a research team member will be conducted to train participants in using the mobile app.
The sample size of 50 is consistent with a pilot feasibility study design.
Methods
The EMA protocol involves four daily assessments of patient-reported outcomes over 14 days, capturing pain, fatigue, sleep quality, and affective states.
EMA prompts will be delivered upon awakening, at 11:00, at 15:00, and at 20:30 each day.
Patient-reported outcomes (PROs) include pain, fatigue, sleep quality, and positive and negative affective states.
The 14-day duration was chosen to capture within-person variability over an ecologically meaningful period.
Data are collected in real-time in participants' natural environments, enabling context-sensitive monitoring.
Methods
Physical activity and sleep will be continuously and objectively monitored using both a wrist-worn and a thigh-worn actigraphy device simultaneously throughout the 14-day protocol.
The use of two concurrent devices (wrist-worn and thigh-worn) allows for more comprehensive and validated measurement of physical activity and sleep.
Actigraphy wear time will be used as a key metric for evaluating feasibility.
Objective actigraphy data will be combined with subjective EMA data to explore relationships between symptoms and physical activity.
Methods
Feasibility will be evaluated based on adherence to EMA prompts and actigraphy wear time, while acceptability will be assessed via a study-specific questionnaire and qualitative interviews at the end of the protocol.
The combination of quantitative (questionnaire) and qualitative (interviews) acceptability assessments is designed to provide a comprehensive understanding of participant experience.
Qualitative interviews will be conducted at the end of the 14-day protocol.
These dual primary outcomes of feasibility and acceptability are the main aims of the pilot study.
Methods
Exploratory analyses will examine real-time, temporal, and lagged relationships between patient-reported outcomes, sleep, and physical activity levels.
Analyses will investigate associations among pain, fatigue, affective states, sleep, and objectively measured physical activity.
Both contemporaneous (same time-point) and lagged (cross-day or cross-prompt) relationships will be examined.
These analyses are described as exploratory, consistent with the pilot nature of the study.
The study protocol was approved by the French national ethics committee (Comité de protection des personnes Nord Ouest I, 2025-A01349-40) on 24/07/2025 and registered as NCT07167784.
What This Means
This paper describes the design of a pilot study that will investigate whether it is practical and acceptable for people with rheumatoid arthritis (RA) or spondyloarthritis (SpA) — two chronic inflammatory joint diseases — to participate in an intensive 14-day monitoring protocol. Fifty participants will answer questions on their smartphones four times a day about their pain, fatigue, mood, and sleep quality, while simultaneously wearing two activity-tracking devices (one on the wrist, one on the thigh) around the clock. The researchers want to find out whether patients can stick to this demanding schedule and whether they find it acceptable, since people with these conditions often experience significant fatigue and discomfort that could make participation difficult.
This research suggests that combining ecological momentary assessment (EMA) — which captures how symptoms fluctuate moment-to-moment in real life — with continuous objective physical activity monitoring could provide a much richer picture of how RA and SpA affect daily life than traditional clinic-based assessments. The study will also explore whether patterns in physical activity are linked to next-day pain or fatigue, and vice versa, potentially revealing how exercise and symptoms influence each other over time in this population.
The practical importance of this work is that if the protocol proves feasible and acceptable, it could pave the way for larger studies using the same methods to better understand the day-to-day burden of inflammatory arthritis and to identify the best times or conditions for patients to be physically active. Physical activity is known to help manage symptoms of these diseases, but many patients struggle to exercise regularly, and understanding the real-world barriers and fluctuating symptom patterns could help tailor more effective and personalized support strategies.
Aymard N, Darmaillacq A, Bailly S, Kechichian A, Baillieul S, Bernardy C, et al.. (2026). Ecological momentary assessment of daily patient-reported outcomes and actigraphy-measured physical activity and sleep in patients with rheumatoid arthritis and spondyloarthritis: a study protocol.. BMJ open. https://doi.org/10.1136/bmjopen-2025-113370