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

NCT ID: NCT07167784

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-05
• Study Completion Date: 2026-09-01

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. Understanding these challenges better 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 phone and wear an actimeter to provide insights into how fatigue, pain, mood, and physical activity levels change throughout the day.

Before using this approach in a larger study, we need to make sure it is practical and acceptable for patients. This pilot study will assess whether participants find the mobile app and actimeter easy to use, how often they respond to surveys, and whether frequent reminders affect their willingness to participate. The study will also examine the immediate and delayed effects of different symptoms on physical activity and explore factors that influence patient engagement with the protocol.

By identifying potential barriers and solutions, this research will help refine future studies and improve the way we monitor and support people with IRDs in staying active while managing their symptoms.

Conditions

Rheumatoid Arthritis &Amp;Amp;Amp; Other Inflammatory Polyarthropathies; Spondyloarthritis (SpA)

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Interventions

Ecological Momentary Assessment

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults (≥18 years) with a confirmed diagnosis of CIRDs, including RA or SpA, established by a rheumatologist, are eligible for inclusion. Participants must be able to understand and consent to the study protocol, be affiliated with a social security system, and 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, as well as 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Grenoble Alpes

Grenoble, France, France

Countries

France

Central Contacts

Monique Mendelson, PhD

Role: CONTACT

mmendelson@chu-grenoble.fr

33-4-76767226

Other Identifiers

EssaiClinique_DYNAMIC

Identifier Type: -

Identifier Source: org_study_id