Spondyloarthritis (SpA)DYNAMICNCT07167784
Ecological Momentary Assessment and Physical Activity in Patients With Inflammatory Rheumatic Diseases
An observational study of Spondyloarthritis (SpA) and Rheumatoid Arthritis & Other Inflammatory Polyarthropathies, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthritis (SpA), Rheumatoid Arthritis & Other Inflammatory Polyarthropathies
- What is being tested?
- Ecological Momentary Assessment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2025to 3 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults diagnosed with Chronic inflammatory rheumatic diseases (rheumatoid arthritis or spondyloarthritis)
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ecological Momentary Assessment to Explore Fatigue, Pain, Sleep, Mood and Physical Activity Levels in Patients With Inflammatory Rheumatic Disease
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.
Read more
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.
- Being tested
- Ecological Momentary Assessment
- Keywords
- Ecological Momentary Assessment, Chronic Inflammatory Rheumatic Diseases, physical activity, fatigue, sleep, pain, actigraphy
- Medical subject headings
- Spondylarthritis, Arthritis, Rheumatoid, Motor Activity, Fatigue, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecological Momentary AssessmentOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Day 1 to Day 14 after enrollment
Secondary outcomes (4)
Immediate and Lagged Effects on Physical Activity
To examine the temporal relationships between pain, fatigue, and sleep, considering their reciprocal influences and variations across different times of the day
Measured: Day 1 to Day 14 after enrollment
Immediate and Lagged Effects of Determinants on Physical Activity
To describe both the immediate and lagged effects of these factors on objectively measured physical activity
Measured: Day 1 to Day 14 after enrollment
Adherence and Acceptability of Two Actigraph Devices
To compare adherence to and acceptability of two actigraph devices assessing physical activity, sleep, and sedentary behavior, worn at two different body sites
Measured: Day 1 to Day 14 after enrollment
Patient-Perceived Acceptability
To explore the qualitative determinants of protocol acceptability directly from the patients' perspective
Measured: Day 1 to Day 14 after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start24 Nov 2025
- Primary completion3 Apr 2026
- Study completion3 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spondyloarthritis (SpA)Studies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167784
- Sponsor's protocol ID
- EssaiClinique_DYNAMIC
- Acronym
- DYNAMIC
- Status last verified
- Apr 2026
- First submitted
- 3 Sep 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in this study will be made available.
Publications
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.
PubMed 41667166
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ecological Momentary Assessment to Explore Fatigue, Pain, Sleep, Mood and Physical Activity Levels in Patients With Inflammatory Rheumatic Disease
- ClinicalTrials.gov ID
- NCT07167784
- Acronym / sponsor ID
- DYNAMIC / EssaiClinique_DYNAMIC
- Keywords
- Ecological Momentary Assessment, Chronic Inflammatory Rheumatic Diseases, physical activity, fatigue, sleep, pain, actigraphy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 3 Apr 2026 (actual)
- Study completion
- 3 Apr 2026 (actual)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults diagnosed with Chronic inflammatory rheumatic diseases (rheumatoid arthritis or spondyloarthritis)
Key inclusion criteria (10 listed)
- 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).
- Insufficient proficiency in the French language
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecological Momentary AssessmentParticipants 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. | Other | – |
Primary outcome
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).
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.
4 secondary outcomes
Immediate and Lagged Effects on Physical Activity
Time frame: Day 1 to Day 14 after enrollment
Immediate and Lagged Effects of Determinants on Physical Activity
Time frame: Day 1 to Day 14 after enrollment
Adherence and Acceptability of Two Actigraph Devices
Time frame: Day 1 to Day 14 after enrollment
Patient-Perceived Acceptability
Time frame: Day 1 to Day 14 after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Derived from this study: PubMed 41667166Aymard 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in this study will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondyloarthritis (SpA) and Rheumatoid Arthritis & Other Inflammatory Polyarthropathies, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a 14-day smartphone EMA protocol combined with actigraphy (time frame: Day 1 to Day 14 after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07167784, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.