OsteoarthritisNCT04791462
COVID-19 in Osteoarthritis Patients
An observational study of Osteoarthritis, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Osteoarthritis
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2021to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a physician-confirmed diagnosis of osteoarthritis of the lower limbs
Who may be able to join
- OA patients
Who cannot join
- active or passive opposition of the patient and / or its legal representatives to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Descriptive Study of Stress Symptoms Related to the COVID-19 Outbreak in a Cohort of 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.
- Conditions
- Osteoarthritis
- Keywords
- lower limbs, anxiety, stress, Covid19
- Medical subject headings
- Osteoarthritis, Anxiety Disorders, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Secondary outcomes (4)
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
Measured: 1 day
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
Measured: 1 day
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
Measured: 1 day
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start10 Mar 2021
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves-Marie PERS, M.D., Ph. D., Principal investigator, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791462
- Sponsor's protocol ID
- RECHMPL21_0109
- Status last verified
- Apr 2022
- First submitted
- 26 Feb 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Descriptive Study of Stress Symptoms Related to the COVID-19 Outbreak in a Cohort of Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT04791462
- Acronym / sponsor ID
- RECHMPL21_0109
- Conditions
- Osteoarthritis
- Keywords
- lower limbs, anxiety, stress, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a physician-confirmed diagnosis of osteoarthritis of the lower limbs
Key inclusion criteria (1 listed)
- OA patients
Key exclusion criteria (1 listed)
- active or passive opposition of the patient and / or its legal representatives to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
4 secondary outcomes
To evaluate the level of anxiety/depression
Time frame: 1 day
To evaluate the level of stress perceived
Time frame: 1 day
To evaluate the level of physical activity
Time frame: 1 day
Assess demographic influencing perceived stress, anxiety/depression, physical activity, post-traumatic stress disorder
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Osteoarthritis
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Holistic Healing for Knee Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves-Marie PERS, M.D., Ph. D. principal investigator
UH Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the state of post-traumatic stress (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.