Effect of a Health Pathway for People With Persistent Symptoms Covid-19
- Conditions
- COVID-19
- Interventions
- Other: usual care and follow-up by a nurseOther: Personalized Multifactorial Intervention (IMP)
- Registration Number
- NCT05787366
- Brief Summary
People with persistent symptoms of covid-19 have increased needs for needs for management of their overall health (physical, psychological and social). Persistent covid-19 symptoms have a negative impact on quality of life. By proposing a follow-up and an intervention on the reduction of these symptoms, the symptoms, the study will improve quality of life.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
Not provided
- Refused to participate in the study
- Person under legal protection
- Person with severe cognitive impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual care usual care and follow-up by a nurse usual care and follow-up by a nurse: control group receiving conventional management, i.e. referral to a specialist(s) according to symptoms, as well as nursing follow-up. Intervention group Personalized Multifactorial Intervention (IMP) usual care and Personalized Multifactorial Intervention: group benefiting from the Personalized Multifactorial Intervention coordinated by a nurse
- Primary Outcome Measures
Name Time Method the evolution of the quality of life at the end of the 6-month follow-up measurement of quality of life at the end of the 6-month follow-up assess by the SF-36 questionnaire. This questionnaire has eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Each question is evaluated on a Likert scale, with 3, 5 or 6 levels of possible answers. The 8 dimensions are also used to calculate two quality of life scores for individuals: the physical composite score (PCS) and the mental composite score (MCS). The higher the score, the greater the ability.
- Secondary Outcome Measures
Name Time Method impact on hyperventilation symptoms at 3 and 6 months Measuring the impact on hyperventilation symptoms with the Nijmegen score. It is a score with sixteen items ranked from 0 (never occurs) to 4 (occurs, very often). A score ≥ 23/64 is suggestive of hyperventilation.
impact on frailty at 3 and 6 months Measuring the impact on frailty by Fried frailty phenotype which assess 5 dimensions : Denutrition, Fatigue, Muscle weakness, Slowing down, Low level of physical activity.
impact on comorbidities at 3 and 6 months Measuring the impact on comorbidities by Charlson comorbidity index. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found.
impact on fatigue symptoms at 3 and 6 months Measuring the impact on fatigue symptoms with the Chadler fatigue scale. This is a 11-item scale divided into two components that measures physical fatigue and mental fatigue. Respondents can give a score of 0 to 3 to indicate how each statement applies to them, from "less than usual" to "much more than usual. The scores for each item are then summed to produce an overall score (ranged 0 to 33). Higher the score is, higher the fatigue is.
impact on cognitive impairment symptoms at 3 and 6 months Measuring the impact on cognitive impairment symptoms with the Montreal Cognitive Assessment. A maximum score out of 30 points will thus be obtained. Smaller the score is, higher the cognitive impairment is.
impact on dyspnea symptoms at 3 and 6 months Measuring the impact on dyspnea symptoms with The Medical Research Council modified dyspnea scale. It is used to subjectively grade the severity of dyspnea in patients with chronic obstructive pulmonary disease (ranged 0-4).The higher the stage, the more severe the dyspnea.
impact on neuropathic pain symptoms at 3 and 6 months Measuring the impact on neuropathic pain symptoms with the DN4 questionnaire. At the end of the questionnaire, add up the 'yes' answers giving a total score out of 10. If the patients score is greater than or equal to 4, the test indicates that the patient is likely to be suffering from neuropathic pain.
impact on musculoskeletal disorders symptoms at 3 and 6 months Measuring the impact on musculoskeletal disorders symptoms with Nordic style questionnaire. The Nordic questionnaire is made up of closed questions, and can be used as a self-questionnaire or an interview. The questionnaire was created to answer the following question: "Does an osteoarticular pathology exist in the given population and if so, which body region does it affect?". Based on this idea, the questionnaire includes a diagram of the human body seen from behind, divided into nine anatomical regions. The question "have you at any time during the last 12 months or 7 days had a problem (pain, discomfort, discomfort)?" is asked for each anatomical region.
impact on quality of life at 3 months Measuring the impact on quality of life assess by the SF-36 questionnaire. This questionnaire has eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Each question is evaluated on a Likert scale, with 3, 5 or 6 levels of possible answers. The 8 dimensions are also used to calculate two quality of life scores for individuals: the physical composite score (PCS) and the mental composite score (MCS). The higher the score, the greater the ability.
impact on post-exertional malaise at 3 and 6 months Measuring the impact on post-exertional malaise. It consist of 10 questions with a Likert scale. Each question is said to be positive when the two associated scores (severity and frequency) are ≥ 2. Active post-exertional malaise are said to be present when at least one of the 5 situations questioned is positive.
impact on anxiety and drepssion at 3 and 6 months impact on anxiety and drepssion via the HAD questionnaire. It includes 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thus making it possible to obtain two scores (maximum score for each score = 21)
Trial Locations
- Locations (3)
Chu Saint-Etienne
🇫🇷Saint Etienne, France
Urps Medecins Libéraux Auvergne-Rhône-Alpes
🇫🇷Lyon, France
DAC Loire
🇫🇷Saint-Étienne, France