Clinical trial NCT04791462: COVID-19 in Osteoarthritis Patients
Official title: Observational Descriptive Study of Stress Symptoms Related to the COVID-19 Outbreak in a Cohort of Osteoarthritis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: lower limbs
anxiety
stress
Covid19
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a physician-confirmed diagnosis of osteoarthritis of the lower limbs

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.


Eligibility criteria: Inclusion criteria:

- OA patients

Exclusion criteria:

* active or passive opposition of the patient and / or its legal representatives to participate in the study.

Primary outcomes:
measure: Assessing the state of post-traumatic stress
timeFrame: 12 months
Secondary outcomes:
measure: To evaluate the level of anxiety/depression
timeFrame: 1 day
measure: To evaluate the level of stress perceived
timeFrame: 1 day
measure: To evaluate the level of physical activity
timeFrame: 1 day
measure: Assess demographic influencing perceived stress, anxiety/depression, physical activity, post-traumatic stress disorder
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: UH Montpellier
name: Yves-Marie PERS, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: