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Completed

NCT Number: NCT07167784

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

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.

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Key information

Conditions

Spondyloarthritis (SpA) Arthritis Arthritis, Rheumatoid Autoimmune Diseases Behavior Bone Diseases Connective Tissue Diseases Fatigue Immune System Diseases Joint Diseases Motor Activity Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis & Other Inflammatory Polyarthropathies Signs and Symptoms Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Grenoble Alpes

Grenoble, France, 38000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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).

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

    Time frame: 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.

Secondary outcomes

  1. Immediate and Lagged Effects on Physical Activity

    Time frame: Day 1 to Day 14 after enrollment

    To examine the temporal relationships between pain, fatigue, and sleep, considering their reciprocal influences and variations across different times of the day

  2. Immediate and Lagged Effects of Determinants on Physical Activity

    Time frame: Day 1 to Day 14 after enrollment

    To describe both the immediate and lagged effects of these factors on objectively measured physical activity

  3. Adherence and Acceptability of Two Actigraph Devices

    Time frame: Day 1 to Day 14 after enrollment

    To compare adherence to and acceptability of two actigraph devices assessing physical activity, sleep, and sedentary behavior, worn at two different body sites

  4. Patient-Perceived Acceptability

    Time frame: Day 1 to Day 14 after enrollment

    To explore the qualitative determinants of protocol acceptability directly from the patients' perspective

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Ecological Momentary Assessment to Explore Fatigue, Pain, Sleep, Mood and Physical Activity Levels in Patients With Inflammatory Rheumatic Disease

Acronym: DYNAMIC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2025
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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