Impact of Life Events and Psychological Stress in Rheumatoid Arthritis Set-up : Case-control Study Within a Multifactorial and Integrative Psychological Model
Stress-PR
1 other identifier
observational
152
1 country
5
Brief Summary
Rheumatoid Arthritis (RA) is an inflammatory rheumatic disease that can lead to structural damage and handicap. The RA physiopathology is multifactorial, including genetic and environmental risk factors. The identification of environmental factors implication is crucial to understand the RA mechanism, and improves the diagnosis and the treatment of the disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2018
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2018
CompletedFirst Posted
Study publicly available on registry
June 8, 2018
CompletedStudy Start
First participant enrolled
June 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 4, 2019
CompletedSeptember 12, 2019
September 1, 2019
1.1 years
May 28, 2018
September 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Life events calculated over the year preceding the onset of PR symptoms
Social Readjustment Rating Scale (SRRS)
At inclusion (day 0)
Secondary Outcomes (10)
Perceived stress
At inclusion (day 0)
Perceived control
At inclusion (day 0)
Perceived social support
At inclusion (day 0)
State Anxiety
At inclusion (day 0)
Coping
At inclusion (day 0)
- +5 more secondary outcomes
Study Arms (2)
Rheumatoid Arthritis patients
patients affected by RA according to ACR/EULAR 2010 criteria, with a disease duration less than 2 years
control patients
patients with a visceral surgery for less than 2 years (appendectomy, cholecystectomy, bowel obstruction, hernia, eventration…)
Interventions
Eligibility Criteria
Patients affected by RA according to ACR/EULAR 2010 criteria, with a disease duration less than 2 years
You may qualify if:
- patients aged over 18 years old
- patients affected by RA according to ACR/EULAR 2010 criteria, with a disease duration less than 2 years.
- Speaking and understanding French language
- Being informed about the study and having given his oral consent
You may not qualify if:
- Pregnant or breastfeeding women
- Patient who refuse to participate.
- Control :
- patients aged over 18 years old
- patients with a visceral surgery for less than 2 years (appendectomy, cholecystectomy, bowel obstruction, hernia, eventration…)
- Speaking and understanding French language
- Being informed about the study and having given his oral consent
- Pregnant or breastfeeding women
- Patient who refuse to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
CHU de Bordeaux - service de rhumatologie
Bordeaux, France
CH de Dax - service de rhumatologie
Dax, France
Hôpital Suburbain du Bouscat
Le Bouscat, France
CH de Libourne - service de rhumatologie
Libourne, France
CH de Pau - service de rhumatologie
Pau, France
Biospecimen
blood sample
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thierry SCHAEVERBEKE, Prof
University Hospital, Bordeaux
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2018
First Posted
June 8, 2018
Study Start
June 13, 2018
Primary Completion
July 4, 2019
Study Completion
July 4, 2019
Last Updated
September 12, 2019
Record last verified: 2019-09