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Clinical Trials/NCT04791462
NCT04791462
Completed
Not Applicable

Observational Descriptive Study of Stress Symptoms Related to the COVID-19 Outbreak in a Cohort of Osteoarthritis Patients

University Hospital, Montpellier1 site in 1 country500 target enrollmentMarch 10, 2021
ConditionsOsteoarthritis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
University Hospital, Montpellier
Enrollment
500
Locations
1
Primary Endpoint
Assessing the state of post-traumatic stress
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

While the coronavirus pandemic has spread rapidly around the world, it has generated a considerable degree of fear, concern and anxiety among the population in general and among certain groups in particular, such as older persons. Initial findings from studies in China indicated the presence of moderate to severe psychological impact in a significant proportion of individuals and an increased prevalence of post-traumatic stress symptoms. It should also be noted that other types of symptoms, such as anxiety and depression, appeared to persist over time and to a greater extent.

Osteoarthritis can develop in any joint, but most often affects the knees, hands and hips. People with osteoarthritis are often older and sometimes more frail than the general population. The main recommendations for non-drug treatment of osteoarthritis include education, physical activity and structured exercise programmes with or without weight reduction. Due to the confinement associated with COVID-19, many patients have had to stop exercise/physical activity and postpone prosthetic surgery. Apart from the context of delay in surgery, there is little data available on the impact of the pandemic on people with arthritis. Several questions are therefore still pending concerning the impact of the pandemic on these patients.

The investigators hypothesise that the following therapeutic modalities have been disrupted during this period: access to care, scheduling of prosthetic surgery, consumption of painkillers or NSAIDs, recourse to physical activities, recourse to physiotherapy sessions, weight changes, level of pain.... Our objective is to evaluate the physical, social, psychological and behavioural consequences of the COVID-19 pandemic in a cohort of osteoarthritis patients.

Registry
clinicaltrials.gov
Start Date
March 10, 2021
End Date
December 30, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Assessing the state of post-traumatic stress

Time Frame: 12 months

Assessing the state of post-traumatic stress in OA patients 12 months after the start of the COVID-19 outbreak (use of the PCL-5 score, with a discriminating threshold score of 38 out of a total score of 80)

Secondary Outcomes

  • To evaluate the level of anxiety/depression(1 day)
  • To evaluate the level of stress perceived(1 day)
  • Assess demographic influencing perceived stress, anxiety/depression, physical activity, post-traumatic stress disorder(1 day)
  • To evaluate the level of physical activity(1 day)

Study Sites (1)

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