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OpenTrials
Completed

NCT Number: NCT04791462

COVID-19 in Osteoarthritis Patients

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • OA patients

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 10, 2021
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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