search
Back to results

Effect of a Health Pathway for People With Persistent Symptoms Covid-19 (SPACO+)

Primary Purpose

COVID-19

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
usual care and follow-up by a nurse
Personalized Multifactorial Intervention (IMP)
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COVID-19 focused on measuring health pathway, quality of life, personalized multifactorial intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Persons who have been infected with Covid-19. 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

Sites / Locations

  • Urps Medecins Libéraux Auvergne-Rhône-Alpes
  • Chu Saint-Etienne
  • Chaire Santé des Aînés
  • DAC Loire

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Usual care

Intervention group

Arm Description

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.

usual care and Personalized Multifactorial Intervention: group benefiting from the Personalized Multifactorial Intervention coordinated by a nurse

Outcomes

Primary Outcome Measures

the evolution of the quality of life
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

impact on quality of life
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 frailty
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
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 dyspnea symptoms
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 hyperventilation symptoms
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 fatigue symptoms
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 neuropathic pain symptoms
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 cognitive impairment symptoms
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 musculoskeletal disorders symptoms
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 post-exertional malaise
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
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)

Full Information

First Posted
March 24, 2023
Last Updated
June 16, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
search

1. Study Identification

Unique Protocol Identification Number
NCT05787366
Brief Title
Effect of a Health Pathway for People With Persistent Symptoms Covid-19
Acronym
SPACO+
Official Title
Effect of a Health Pathway for People With Persistent Symptoms Covid-19
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
health pathway, quality of life, personalized multifactorial intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, multicenter, controlled, randomized open-labelled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Other
Arm Description
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.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
usual care and Personalized Multifactorial Intervention: group benefiting from the Personalized Multifactorial Intervention coordinated by a nurse
Intervention Type
Other
Intervention Name(s)
usual care and follow-up by a nurse
Intervention Description
follow-up by a nurse and referral to a specialist(s) according to symptoms
Intervention Type
Other
Intervention Name(s)
Personalized Multifactorial Intervention (IMP)
Intervention Description
The content of the intervention is defined according to the result of the initial assessment in relation to the person's needs and the nature of his or her persistent symptoms. The patient, depending on his or her needs, may choose to participate in the following workshops : Knowledge of the disease and specific management, (led by the nurse) Covid-19 and anxiety/depression, (psychologist) Fatigue and adapted physical activities (video capsules) Covid-long and social link (professional and voluntary activities...) (social worker and/or nurse) The Recovery Café aims to provide a space for patients to listen to each other and share their experiences around themes related to the different dimensions of recovery: medical and psychological, economic, professional, social and existential.
Primary Outcome Measure Information:
Title
the evolution of the quality of life
Description
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.
Time Frame
at the end of the 6-month follow-up
Secondary Outcome Measure Information:
Title
impact on quality of life
Description
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.
Time Frame
at 3 months
Title
impact on frailty
Description
Measuring the impact on frailty by Fried frailty phenotype which assess 5 dimensions : Denutrition, Fatigue, Muscle weakness, Slowing down, Low level of physical activity.
Time Frame
at 3 and 6 months
Title
impact on comorbidities
Description
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.
Time Frame
at 3 and 6 months
Title
impact on dyspnea symptoms
Description
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.
Time Frame
at 3 and 6 months
Title
impact on hyperventilation symptoms
Description
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.
Time Frame
at 3 and 6 months
Title
impact on fatigue symptoms
Description
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.
Time Frame
at 3 and 6 months
Title
impact on neuropathic pain symptoms
Description
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.
Time Frame
at 3 and 6 months
Title
impact on cognitive impairment symptoms
Description
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.
Time Frame
at 3 and 6 months
Title
impact on musculoskeletal disorders symptoms
Description
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.
Time Frame
at 3 and 6 months
Title
impact on post-exertional malaise
Description
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.
Time Frame
at 3 and 6 months
Title
impact on anxiety and drepssion
Description
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)
Time Frame
at 3 and 6 months
Other Pre-specified Outcome Measures:
Title
obstacles and levers to participation and adherence to the intervention, as well as the satisfaction of patients and professionals
Description
Evaluation of the obstacles and levers to participation and adherence to the intervention, as well as the satisfaction of patients and professionals via semi-directive interviews conducted by a sociologist during the implementation of the intervention
Time Frame
at 3 and 6 months
Title
Effectivness of the intervention
Description
Assess the effectivness of the system through a cost-utility analysis
Time Frame
at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Persons who have been infected with Covid-19. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline DUPRE, PhD
Phone
0477816352
Ext
+33
Email
caroline.dupre@univ-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric ROCHE, PhD
Organizational Affiliation
CHU de Saint Etienne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bienvenu BONGUE, phD
Organizational Affiliation
Université Jean Monnet
Official's Role
Study Director
Facility Information:
Facility Name
Urps Medecins Libéraux Auvergne-Rhône-Alpes
City
Lyon
ZIP/Postal Code
69006
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise RUIZ
First Name & Middle Initial & Last Name & Degree
Louise
Facility Name
Chu Saint-Etienne
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric ROCHE, PhD
Phone
(0)0477828695
Ext
+33
Email
frederic.roche@chu-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Elisabeth BOTELHO-NEVERS, MD PhD
First Name & Middle Initial & Last Name & Degree
David HUPIN, MD
Facility Name
Chaire Santé des Aînés
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda KAMDEM
Facility Name
DAC Loire
City
Saint-Étienne
ZIP/Postal Code
42100
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario DEBELLIS

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of a Health Pathway for People With Persistent Symptoms Covid-19

We'll reach out to this number within 24 hrs