Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570239
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Evaluation of the Effectiveness of a Spa Treatment for People With Post-Covid 19 Conditions
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Spa Management Hydrokinesitherapy and Crenobalneotherapy Compared With Usual Management of People With Post-Covid-19 Conditions a Randomized Open-label Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVIDTHERM
Brief Summary:
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
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
Detailed Description:
Justificationcontext
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 390 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 andor 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 paindiscomfort 39 and anxietydepression 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 warrant hospitalization for treatment of the initial phase of Covid
Secondary objectives
The secondary objectives of this project are
Compare changes in overall quality of life at 12 months between Protocols A and B
Compare short- M2 and medium- M12 term changes in persistent symptoms between Protocols A and B
Compare short M2 and medium M12 term changes in other dimensions of quality of life according to Protocols A and B mobility autonomy usual activities paindiscomfort anxietydepression
Compare the effect of protocol B versus protocol A on return to work nature delay and volume
Analyze post-covid-19 symptom profiles and their association with post-infection quality-of-life trajectories
Analyze and compare the mechanisms and conditions of efficacy of protocols A and B dose of intervention received appropriateness of the intervention to the realities of the field and the needs of the target population patient commitment and satisfaction
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
Variation in mean utility score EQ-5D-5L calculated in each management group protocol A and protocol B between V0 and V3 V4 and V5 including Vend
Variation in the following parameters number of symptoms and symptom clusters rating by symptom scales and tests Appendices asthenia Chalder fatigue scale 5 sleep disorders Insomnia Severity Index ISI 6 pain visual analog pain scale 25 anxiety-depression HAD scale 7 post-traumatic stress PCL-5 scale 8 dyspnea mMRC-modified Medical Research Council scale and modified Borg scale 910 lower-limb muscular strength standing-sitting test 1112 6-minute stepper test 13 postural balance on posturography platform with sensitization by modification of somato-sensory afferents foam tray and visual virtual reality goggles 1415 balance tests monopodal support eyes open and closed
Variation in scores for the 5 items and the visual analog scale VAS comprising the EQ-5D-5L questionnaire
Data on return to work time taken to return to work part-time or full-time modified post etc
Number of medical consultations consumption of physiotherapy psychology and other paramedical care analgesics anxiolytics antidepressants systemic or inhaled corticoids bronchodilators and antihistamines not included in the protocol
Methods
This is a regional multicenter randomized controlled open-label study Patients will be randomized 11 per center into two different intervention arms
Control arm Protocol A dry rehabilitation protocol for 3 weeks and psychological support for 8 weeks
Intervention arm Protocol B natural mineral water rehabilitation protocol for 3 weeks and psychological support for 8 weeks
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 11 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 012 and a minimum difference to be highlighted of 005 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
Patients who have received full information on the organization of the research who have not objected to their participation and to the use of their data and who have given their free and informed consent in writing
Patients aged 18 and over
Patients with a history of symptomatic Covid-19 infection documented by RT-PCR antigenic test positive serology in a previously unvaccinated patient or other validated virological diagnostic test at the patients inclusion date
No hospitalization for treatment of the initial phase of Covid-19
Person presenting at least two common symptoms of post-Covid disease including fatigue shortness of breath and cognitive dysfunction which have appeared de novo and have been evolving for more than 12 weeks and present for more than 8 weeks
Initial and prolonged symptoms not explained by another diagnosis with no known link to Covid-19
Normal SpO2 at rest not decreasing beyond 4 on exercise
Membership of a social security scheme or beneficiary of such a scheme
Criteria for non-inclusion of research subjects
Acute cardiovascular disease acute coronary syndrome arrhythmia heart failure venous thromboembolism myocarditis stroke acute ischemia etc less than 3 months old and at risk of recurrence or decompensation
Respiratory disease COPD interstitial fibrosis exercise-induced desaturation sleep apnea
Stroke less than 6 months old
Pregnant women
adults under legal protection guardianship curatorship safeguard of justice
Severe and unstabilized psychiatric pathology severe depressive syndrome delirious decompensation panic attacks anxiety-depression syndrome
Acute and progressive conditions infectious cancerous and inflammatory
Persons presenting a contraindication to hydrokinesitherapy and crenotherapy infected dermatoses severe immune deficiencies inflammatory diseases in flare-ups fecal or urinary incontinence presence of a suprapubic or intravenous catheter colostomy hydrophobia
Refusal to sign the free and informed consent form
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 studys 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 1week
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 patients 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 1week
Acts requiring logistics
Training of Covid Long staff doctors physiotherapists
Patient questionnaires
Organization of psychology teleconsultations
Organization of semi-structured interviews
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 ie 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 subjects identity
Assessing the benefits and risks of research
Expected benefits
Validation of the effectiveness of rehabilitative and supportive care in the management of people suffering from post-covid symptoms
Demonstration of the superiority of hydrokinesitherapy and crenotherapy over conventional rehabilitation in primary care with both protocols performed in accordance with HAS recommendations
Validation of a specific care pathway adapted to patients with persistent symptoms following Covid-19
Provision of a dedicated care pathway for primary care physicians with health professionals trained and available for this type of care
The risks are those associated with
dry rehabilitation risk of over-intensive rehabilitation
hydrokinesitherapy rehabilitation risk associated with thermoregulation disorders in an aquatic environment
thermal treatment
infections transmitted by other spa guests mainly benign ENT infections
legionellosis risk controlled by hygiene measures introduced in spa establishments decree of June 19 2000 on the management of microbial risk linked to mineral water in spa establishments
Risk of slips and falls in the establishment
Statistical analysis
The programs 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 andor parametric Students 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
Agence Régionale de Santé ARS-Grand Est
CNETh Conseil National des Établissements Thermaux
Région Grand Est
Metropole du Grand Nancy
A budget of 207000 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
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 390 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 andor 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 paindiscomfort 39 and anxietydepression 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 warrant hospitalization for treatment of the initial phase of Covid
Secondary objectives
The secondary objectives of this project are
Compare changes in overall quality of life at 12 months between Protocols A and B
Compare short- M2 and medium- M12 term changes in persistent symptoms between Protocols A and B
Compare short M2 and medium M12 term changes in other dimensions of quality of life according to Protocols A and B mobility autonomy usual activities paindiscomfort anxietydepression
Compare the effect of protocol B versus protocol A on return to work nature delay and volume
Analyze post-covid-19 symptom profiles and their association with post-infection quality-of-life trajectories
Analyze and compare the mechanisms and conditions of efficacy of protocols A and B dose of intervention received appropriateness of the intervention to the realities of the field and the needs of the target population patient commitment and satisfaction
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
Variation in mean utility score EQ-5D-5L calculated in each management group protocol A and protocol B between V0 and V3 V4 and V5 including Vend
Variation in the following parameters number of symptoms and symptom clusters rating by symptom scales and tests Appendices asthenia Chalder fatigue scale 5 sleep disorders Insomnia Severity Index ISI 6 pain visual analog pain scale 25 anxiety-depression HAD scale 7 post-traumatic stress PCL-5 scale 8 dyspnea mMRC-modified Medical Research Council scale and modified Borg scale 910 lower-limb muscular strength standing-sitting test 1112 6-minute stepper test 13 postural balance on posturography platform with sensitization by modification of somato-sensory afferents foam tray and visual virtual reality goggles 1415 balance tests monopodal support eyes open and closed
Variation in scores for the 5 items and the visual analog scale VAS comprising the EQ-5D-5L questionnaire
Data on return to work time taken to return to work part-time or full-time modified post etc
Number of medical consultations consumption of physiotherapy psychology and other paramedical care analgesics anxiolytics antidepressants systemic or inhaled corticoids bronchodilators and antihistamines not included in the protocol
Methods
This is a regional multicenter randomized controlled open-label study Patients will be randomized 11 per center into two different intervention arms
Control arm Protocol A dry rehabilitation protocol for 3 weeks and psychological support for 8 weeks
Intervention arm Protocol B natural mineral water rehabilitation protocol for 3 weeks and psychological support for 8 weeks
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 11 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 012 and a minimum difference to be highlighted of 005 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
Patients who have received full information on the organization of the research who have not objected to their participation and to the use of their data and who have given their free and informed consent in writing
Patients aged 18 and over
Patients with a history of symptomatic Covid-19 infection documented by RT-PCR antigenic test positive serology in a previously unvaccinated patient or other validated virological diagnostic test at the patients inclusion date
No hospitalization for treatment of the initial phase of Covid-19
Person presenting at least two common symptoms of post-Covid disease including fatigue shortness of breath and cognitive dysfunction which have appeared de novo and have been evolving for more than 12 weeks and present for more than 8 weeks
Initial and prolonged symptoms not explained by another diagnosis with no known link to Covid-19
Normal SpO2 at rest not decreasing beyond 4 on exercise
Membership of a social security scheme or beneficiary of such a scheme
Criteria for non-inclusion of research subjects
Acute cardiovascular disease acute coronary syndrome arrhythmia heart failure venous thromboembolism myocarditis stroke acute ischemia etc less than 3 months old and at risk of recurrence or decompensation
Respiratory disease COPD interstitial fibrosis exercise-induced desaturation sleep apnea
Stroke less than 6 months old
Pregnant women
adults under legal protection guardianship curatorship safeguard of justice
Severe and unstabilized psychiatric pathology severe depressive syndrome delirious decompensation panic attacks anxiety-depression syndrome
Acute and progressive conditions infectious cancerous and inflammatory
Persons presenting a contraindication to hydrokinesitherapy and crenotherapy infected dermatoses severe immune deficiencies inflammatory diseases in flare-ups fecal or urinary incontinence presence of a suprapubic or intravenous catheter colostomy hydrophobia
Refusal to sign the free and informed consent form
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 studys 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 1week
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 patients 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 1week
Acts requiring logistics
Training of Covid Long staff doctors physiotherapists
Patient questionnaires
Organization of psychology teleconsultations
Organization of semi-structured interviews
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 ie 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 subjects identity
Assessing the benefits and risks of research
Expected benefits
Validation of the effectiveness of rehabilitative and supportive care in the management of people suffering from post-covid symptoms
Demonstration of the superiority of hydrokinesitherapy and crenotherapy over conventional rehabilitation in primary care with both protocols performed in accordance with HAS recommendations
Validation of a specific care pathway adapted to patients with persistent symptoms following Covid-19
Provision of a dedicated care pathway for primary care physicians with health professionals trained and available for this type of care
The risks are those associated with
dry rehabilitation risk of over-intensive rehabilitation
hydrokinesitherapy rehabilitation risk associated with thermoregulation disorders in an aquatic environment
thermal treatment
infections transmitted by other spa guests mainly benign ENT infections
legionellosis risk controlled by hygiene measures introduced in spa establishments decree of June 19 2000 on the management of microbial risk linked to mineral water in spa establishments
Risk of slips and falls in the establishment
Statistical analysis
The programs 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 andor parametric Students 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
Agence Régionale de Santé ARS-Grand Est
CNETh Conseil National des Établissements Thermaux
Région Grand Est
Metropole du Grand Nancy
A budget of 207000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None