COVID-19 in Osteoarthritis Patients

NCT04791462 | Completed

• 1 other identifier: RECHMPL21_0109
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

lower limbs; anxiety; stress; Covid19

Outcome Measures

Primary Outcomes (1)

• Assessing the state of post-traumatic stress

  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)

  12 months

Secondary Outcomes (4)

• To evaluate the level of anxiety/depression

  1 day

• To evaluate the level of stress perceived

  1 day

• To evaluate the level of physical activity

  1 day

• Assess demographic influencing perceived stress, anxiety/depression, physical activity, post-traumatic stress disorder

  1 day

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a physician-confirmed diagnosis of osteoarthritis of the lower limbs

You may qualify if:

• \- OA patients

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Biospecimen

Retention: NONE RETAINED

NC

MeSH Terms

Conditions

Osteoarthritis; Anxiety Disorders; COVID-19

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yves-Marie PERS, M.D., Ph. D.

  UH Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 10, 2021
• Study Start: March 10, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

FR (1)