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Following the acute phase of Covid-19, some patients experience persistent or recurrent symptoms. These symptoms can take a number of forms: intense fatigue, cognitive dysfunction, respiratory difficulties, maladaptation to physical exertion, musculoskeletal pain, anxiety-depressive disorders, malnutrition, loss of sense of smell, headaches and so on. These symptoms are known as post-covid-19 disease, defined by the WHO as "a condition occurring in people with a history of probable or confirmed infection with SARS-CoV-2, usually 3 months after the onset of COVID-19 with symptoms that persist for at least 2 months and cannot be explained by another diagnosis. Common symptoms include fatigue, breathlessness and cognitive dysfunction, as well as other symptoms that generally have an impact on daily functioning.
The aim of this interventional research project is to assess the place of a specific spa treatment for people with a post-Covid 19 condition in the primary care pathway.
Full description
Justification/context
Most of the studies initially published involved cohorts of patients hospitalized during the initial phase. The French Covid-19 cohort, which studied 1137 patients after hospitalization for SARS-CoV-2 infection, showed that 60% complained of at least one symptom still present at 6 months, 24% three or more persistent symptoms, and that 29% of those with a professional activity had not returned to work (1). At 12 months, 34% of women and 23% of men were still on sick leave (2). The susceptibility of adults seems to increase with age, number of symptoms in the acute phase, body mass index, female sex and absence of vaccination (3). The evolution of post-covid disease fluctuates over time (4).
Studies of cohorts of patients followed up in primary care show that post-covid affliction affects people with both severe and mild forms of the disease. As part of the virtual ambulatory follow-up program (CoviCare), 410 people testing positive for COVID-19 at Geneva University Hospital were followed up 7 to 9 months after diagnosis: 39.0% reported residual symptoms. Analysis of a prospective cohort of 247 Norwegian patients followed at home showed that 52% of young adults aged 16 to 30 had symptoms at 6 months, including loss of taste and/or smell (28%), fatigue (21%), dyspnea (13%), impaired concentration (13%) and memory impairment (11) A literature review of quality of life in post-covid conditions conducted between March 2020 and March 2021 (12 studies involving 4828 patients) showed that the combined prevalence of poor quality of life (EQ-VAS) was estimated at 59%. Meta-regression analysis showed that poor quality of life was significantly higher in patients with ICU admission and fatigue. At 2 months, an alteration in quality of life defined by a 10-point difference on the EQ-5D-5L analog scale was noted in 44% of hospitalized patients. The study by Logues et al, involving 177 patients in the United States, showed that 30% of outpatients had an altered quality of life at 9 months, defined as a 10-point decrease in the EQ-VAS compared with the previous situation, versus 2% of non-infected control subjects. Menges et al studied quality of life using the EQ-5D-5L scale in 431 patients in Zurich, 89% of whom were non-hospitalized. They showed that 53% of participants reported difficulties in at least one dimension of the EQ-5D-5L. The dimensions most frequently affected were pain/discomfort (39%) and anxiety/depression (31%).
Primary objective:
To compare the efficacy of a spa-based rehabilitation and support protocol (Protocol B) versus a conventional primary care rehabilitation and support protocol (Protocol A) on changes in overall quality of life at 2 months in patients suffering from post-Covid-19 symptoms who did not warrant́ hospitalization for treatment of the initial phase of Covid
Secondary objectives:
The secondary objectives of this project are:
Primary outcome:
The primary endpoint of this study is the change in utility score derived from quality of life and measured by the EQ-5D-5L at inclusion (V0) and at 2 months after inclusion (V2).
Secondary outcomes:
Methods:
This is a regional multicenter randomized controlled open-label study. Patients will be randomized 1:1 per center into two different intervention arms:
Each included patient will be followed-up for one year with 5 different visits: at inclusion (V0), at one month (V1), at 2 months (V2), at 6 months (V3) and at 12 months (V4).
Number of research participants required:
Randomization will be 1:1 per center, and the primary endpoint is the utility score derived from quality of life and measured by the EQ-5D-5L ranging from 0 (state corresponding to death) to 1 (state of perfect health). We set an alpha risk of 5% and a power of 80%. Estimating a standard deviation of the utility score between the two groups of 0.12 and a minimum difference to be highlighted of 0.05 (equivalent to 5 points out of 100), we will need to include 91 patients per group, for a total of 182 patients. Assuming 10% drop-out during the treatment period (first 3 weeks), we need to include a total of 200 patients in the 4 selected spa centers (Amnéville, Contrexéville, Vittel and Nancy).
Inclusion capacity in the various centers is as follows: Amnéville (60), Contrexéville (30), Vittel (30) and Nancy (80).
Inclusion criteria for research subjects
Criteria for non-inclusion of research subjects:
Recruitment of research subjects (patients, controls where applicable):
The pre-selection of patients will be carried out by the structures dedicated to the care of patients suffering from post-covid conditions in the region: general practitioners, infectious disease specialists, physical medicine and rehabilitation specialists, physiotherapists. They will present the project and hand out the newsletter.
Are specially protected persons concerned? no
Prohibited period:
The person must not be included in any other intervention research during the treatment period for this research. The blackout period corresponds to the period between the inclusion visit at V0 and the V2 visit carried out at the end of the treatment period (2 months after the inclusion visit).
Compensation No compensation is planned for participants in the COVIDTHERM study.
Duration:
The inclusion period is scheduled to last 12 months, and each patient will be followed up for 12 months, for a total of 24 months
Investigation procedures and differences from usual care:
General principle:
Physiotherapists will be trained to harmonize their practices and adapt them to the specific situations of patients with post-Covid symptoms. Psychotherapy sessions will be carried out via teleconsultation, with the aim of facilitating and harmonizing the care of patients included in the study, regardless of their place of residence. Health education materials will be given to patients at the start of the treatment period, when the first assessment is carried out. Topics covered will include Understanding the post-covid condition; Understanding the psychological repercussions; Managing breathing; Managing effort; Rehabilitating the sense of smell; Managing stress; Adapting diet.
For both arms of the study, specific procedures include 3 visits to the study's investigating physician, 5 physiotherapy check-ups and 1 psychological check-up. Participants will be recruited from the population living near the resorts. Transport costs will be covered as part of the study. The prospective resorts in the Grand Est region are : Nancy Thermal, Amnéville-les-Thermes, Contrexéville and Vittel.
Protocol A: Control group Protocol A combines dry physiotherapy, psychological support and health education.
9 outpatient physiotherapy sessions over 3 weeks in the offices of private physiotherapists taking part in the study, or in suitable care facilities agreeing to take part.
1 initial psychological assessment followed by 7 psychological teleconsultations (1/week).
Protocol B: Intervention group Protocol B combines hydrokinesitherapy and hydrotherapy, psychological support and health education (kit containing health education materials).
9 hydrokinesitherapy sessions and 36 hydrothermal treatments* will be carried out over 3 weeks in one of the spa establishments participating in the study and close to the patient's place of residence.
*Hydrothermal treatments include affusion massage, jet shower, aerobath and pool mobilization, corresponding to 4 treatments three times a week for 3 weeks.
Group A and B patients will receive psychological support over an 8-week period. This will include an assessment and 7 teleconsultations (1/week).
Acts requiring logistics :
Nature and origin of the data collected:
Type of data collected for the study :
Sex - age Socio-professional category Family status Health data Covid-19 health data Lifestyle and behavior Working life Lifestyle Location Autonomy Physical abilities Activities of daily living Breathing capacity Neurological disorders Motor functions and musculoskeletal capacities, upper and lower limbs and spine Medical data will be collected from the medical records of the investigating physicians. Socio-demographic and perceived health data will be collected via self-administered questionnaires administered administered to patients. Individual semi-structured interviews will also be conducted with professionals and a sub-sample of 10% of patients, i.e. 20 patients randomly selected and having indicated that they would be willing to participate in an interview conducted at the end of the interventions (M2).
Method of collecting personal data:
The clinical, sociodemographic and perceived health data collected will be entered on an electronic CRF, then stored on a secure server at the CHRU de Nancy in accordance with quality procedures.
Circulation of personal data and procedures for protecting confidentiality:
An anonymity number will be created for each patient. This number will be made up of 4 digits, the first corresponding to the center number and the next three to the number assigned at inclusion in chronological order. The first patient in center 1 will have the number 1 001, and the first patient in center 4 will have the number 4 001.
A correspondence table will be kept securely at each investigating center to link the study number to the subject's identity.
Assessing the benefits and risks of research:
Expected benefits
The risks are those associated with :
Statistical analysis:
The program's primary efficacy criterion will be assessed by comparing mean changes in the overall quality of life score (utility score) at 2 months between the two groups. An analysis of missing data will be performed, and the random or non-random nature of missing data will be investigated (Diggle and Rubins classification). Two types of analysis will be used for the main analysis: a univariate analysis to compare differences in quality of life scores between the two arms: non-parametric (Mann Whitney-Wilcoxon) and/or parametric (Student's t test); a multivariate analysis of variance on repeated measures with adjustment for potential confounding variables (clinical and socio-demographic, and center). A pairwise analysis will also be used to perform a combined analysis of several judgment criteria (quality of life, anxiety, etc.) with their prioritization.
Expected benefits Reduce the intensity, duration and impact on quality of life of persistent post-Covid symptoms, and enable resumption of social and professional activities; Provide French primary care physicians with a dedicated network of healthcare professionals trained and available for this type of care; Position spa treatment within the healthcare pathway of people with post-covid conditions; Provide state-of-the-art symptom management for this emerging pathology; Better understand the natural history of post-covid symptoms.
Funding:
This project is co-financed by the following organizations:
A budget of 207,000 euros has been obtained.
Research schedule and organisation:
Inclusion period: 1 year Duration of follow-up period: 1 year Overall study duration (including analyses): 30 months
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200 participants in 2 patient groups
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Central trial contact
Alfousseyni COLY; Giséle KANNY, PU-PH
Data sourced from clinicaltrials.gov
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