COVID-19 in Osteoarthritis Patients

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ClinicalTrials.gov Identifier: NCT04791462

Recruitment Status : Recruiting

First Posted : March 10, 2021

Last Update Posted : November 15, 2021

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

University Hospital, Montpellier

Study Description

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.

Condition or disease
Osteoarthritis

Study Design

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Study Type :	Observational
Estimated Enrollment :	500 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Observational Descriptive Study of Stress Symptoms Related to the COVID-19 Outbreak in a Cohort of Osteoarthritis Patients
Actual Study Start Date :	March 10, 2021
Estimated Primary Completion Date :	December 30, 2021
Estimated Study Completion Date :	December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Osteoarthritis

MedlinePlus related topics: Anxiety COVID-19 (Coronavirus Disease 2019) Osteoarthritis

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

To evaluate the level of anxiety/depression [ Time Frame: 1 day ]
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
To evaluate the level of stress perceived [ Time Frame: 1 day ]
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
To evaluate the level of physical activity [ Time Frame: 1 day ]
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
Assess demographic influencing perceived stress, anxiety/depression, physical activity, post-traumatic stress disorder [ Time Frame: 1 day ]
Assess demographic influencing perceived stress, anxiety/depression, physical activity, post-traumatic stress disorder

Biospecimen Retention: None Retained

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 100 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

Criteria

Inclusion criteria:

- OA patients

Exclusion criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04791462

Contacts

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Contact: Yves-Marie PERS, M.D., Ph. D.	6 18 99 38 04 ext 33	ym-pers@chu-montpellier.fr
Contact: Christian JORGENSEN, MD, PhD	4 67 33 72 31 ext 33	c-jorgensen@chu-montpellier.fr

Locations

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France
Uhmontpellier	Recruiting
Montpellier, France, 34295
Contact: Yves-Marie PERS
Contact: Christian JORGENSEN

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

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Principal Investigator:	Yves-Marie PERS, M.D., Ph. D.	UH Montpellier

More Information

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Responsible Party:	University Hospital, Montpellier
ClinicalTrials.gov Identifier:	NCT04791462
Other Study ID Numbers:	RECHMPL21_0109
First Posted:	March 10, 2021 Key Record Dates
Last Update Posted:	November 15, 2021
Last Verified:	November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
Plan Description:	NC

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by University Hospital, Montpellier:


lower limbs anxiety stress Covid19

Additional relevant MeSH terms:

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COVID-19 Osteoarthritis Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections	Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

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