COVID-19 in Osteoarthritis Patients

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04791462
• Other study ID #: RECHMPL21_0109
• Status: Completed
• Start date: March 10, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: April 2022
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion criteria:

• OA patients

Exclusion criteria:

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

Related Conditions & MeSH terms

• COVID-19
• Osteoarthritis

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the level of anxiety/depression	To evaluate the level of anxiety/depression in the OA patient defined by the HAD score.; HAD score: Hospital Anxiety and Depression score: Higher values means poor outcome, min 0, max 42	1 day
Secondary	To evaluate the level of stress perceived	To evaluate the level of stress perceived by the OA patient as defined by the PSS14 score.; PSS14 score: Perceived Stress Scale , 14 questions, Rating (0 = Never, 1 = Almost never, 2 = Sometimes, 3 = Quite often, 4 = Very often): Higher score = poor outcome 3/ PCL-5: Post-Traumatic Stress Disorder Checklist Scale, version DSM-V, Items are rated from 0 "not at all" to 4 "extremely". 20 questions, Higher score = poor outcome PCL-5: Post-Traumatic Stress Disorder Checklist Scale, version DSM-V, Items are rated from 0 "not at all" to 4 "extremely". 20 questions, Higher score = poor outcome	1 day
Secondary	To evaluate the level of physical activity	To evaluate the level of physical activity in the OA patient defined by the IPAQ score.; IPAQ: International Physical Activity Questionnaire - Craig et al. 2003; Short version (7 questions). The questionnaire classifies the subject according to 3 levels of activity: inactive, moderate, high	1 day
Secondary	Assess demographic influencing perceived stress, anxiety/depression, physical activity, post-traumatic stress disorder	Assess demographic influencing perceived stress, anxiety/depression, physical activity, post-traumatic stress disorder	1 day