Effect of a Health Pathway for People With Persistent Symptoms Covid-19
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 400
- Locations
- 3
- Primary Endpoint
- the evolution of the quality of life
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Persons who have been infected with Covid-
- •Person with persistent clinical signs of Covid-19 for more than 12 weeks, referred by one of the partner structures of the project. The persistent signs of Covid-19 are: fatigue which can be severe, neurological disorders neurological disorders (cognitive, sensory, headaches), cardio-thoracic disorders (pain and chest tightness, tachycardia, dyspnea, cough) and disorders of smell and taste. Pain, digestive disorders and skin disorders are also common.
- •Person who has agreed to participate and has given informed consent to participate in the study
Exclusion Criteria
- •Refused to participate in the study
- •Person under legal protection
- •Person with severe cognitive impairment
Arms & Interventions
Usual care
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: usual care and follow-up by a nurse (Other)
Intervention group
usual care and Personalized Multifactorial Intervention: group benefiting from the Personalized Multifactorial Intervention coordinated by a nurse
Intervention: Personalized Multifactorial Intervention (IMP) (Other)
Outcomes
Primary Outcomes
the evolution of the quality of life
Time Frame: 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 Outcomes
- impact on hyperventilation symptoms(at 3 and 6 months)
- impact on frailty(at 3 and 6 months)
- impact on comorbidities(at 3 and 6 months)
- impact on fatigue symptoms(at 3 and 6 months)
- impact on cognitive impairment symptoms(at 3 and 6 months)
- impact on dyspnea symptoms(at 3 and 6 months)
- impact on neuropathic pain symptoms(at 3 and 6 months)
- impact on musculoskeletal disorders symptoms(at 3 and 6 months)
- impact on quality of life(at 3 months)
- impact on post-exertional malaise(at 3 and 6 months)
- impact on anxiety and drepssion(at 3 and 6 months)