Ecological Momentary Assessment and Physical Activity in Patients With Inflammatory Rheumatic Diseases

NCT07167784 | Completed DMC

• 1 other identifier: EssaiClinique_DYNAMIC
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spondyloarthritis (SpA); Rheumatoid Arthritis & Other Inflammatory Polyarthropathies

Keywords

Ecological Momentary Assessment; Chronic Inflammatory Rheumatic Diseases; physical activity; fatigue; sleep; pain; actigraphy

Outcome Measures

Primary Outcomes (2)

• Feasibility of a 14-day smartphone EMA protocol combined with actigraphy

  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).

  Day 1 to Day 14 after enrollment

• Acceptability of a 14-day EMA protocol combined with actigraphy delivered via a mobile application

  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.

  Day 1 to Day 14 after enrollment

Secondary Outcomes (4)

• 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

Interventions

Ecological Momentary Assessment OTHER

Participants will be complete four daily EMA surveys via the Avicenna Research app (morning, 11 a.m., 3 p.m., and evening). Participants will be instructed to complete and submit each survey as soon as they see the app notification. If no response is provided within 15 minutes, a reminder notification will be sent. At the end of the 14-day period, devices will be returned using a prepaid envelope provided by the study team and participants will complete an end-of-study questionnaire to assess the acceptability of the study and will be invited to participate in a debriefing interview with a member of the research team.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults diagnosed with Chronic inflammatory rheumatic diseases (rheumatoid arthritis or spondyloarthritis)

You may qualify if:

• 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).
• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble Alpes

Grenoble, France, 38000, France

Location

Related Publications (1)

• Aymard N, Darmaillacq A, Bailly S, Kechichian A, Baillieul S, Bernardy C, Gastaldi R, Flore P, Baillet A, Mendelson M. 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. 2026 Feb 10;16(2):e113370. doi: 10.1136/bmjopen-2025-113370.

  PMID: 41667166 DERIVED

MeSH Terms

Conditions

Spondylarthritis; Arthritis, Rheumatoid; Motor Activity; Fatigue; Pain

Interventions

Ecological Momentary Assessment

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 11, 2025
• Study Start: November 24, 2025
• Primary Completion: April 3, 2026
• Study Completion: April 3, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will become available 6 months after publication of the main results and will remain available for 5 years.
• Access Criteria: Data will be available to researchers who provide a methodologically sound proposal. Requests should be directed to the study coordinator. After approval of the proposal, data will be shared via a secure repository or direct data transfer agreement.

Locations

FR (1)