COVID-19SPACO+NCT05787366
Effect of a Health Pathway for People With Persistent Symptoms Covid-19
A study testing Personalized Multifactorial Intervention (IMP) in people with COVID-19, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Personalized Multifactorial Intervention (IMP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesFrance
- Study dates
- 15 Nov 2023to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Refused to participate in the study
- Person under legal protection
- Person with severe cognitive impairment
Trial locations and contacts
3 sites in 1 country.
France3 sites
Urps Medecins Libéraux Auvergne-Rhône-Alpes
Lyon, 69006
Chu Saint-Etienne
Saint-Etienne, 42055
DAC Loire
Saint-Etienne, 42100
About this study
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.
- Conditions
- COVID-19
- Being tested
- usual care and follow-up by a nurse, Personalized Multifactorial Intervention (IMP)
- Keywords
- health pathway, quality of life, personalized multifactorial intervention
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usual care and follow-up by a nurseOther
follow-up by a nurse and referral to a specialist(s) according to symptoms
Personalized Multifactorial Intervention (IMP)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Other | 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. Receives: Other: usual care and follow-up by a nurse |
| Intervention group | Experimental | usual care and Personalized Multifactorial Intervention: group benefiting from the Personalized Multifactorial Intervention coordinated by a nurse Receives: Other: Personalized Multifactorial Intervention (IMP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the end of the 6-month follow-up
Secondary outcomes (11)
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.
Measured: at 3 months
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.
Measured: at 3 and 6 months
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.
Measured: at 3 and 6 months
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.
Measured: at 3 and 6 months
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.
Measured: at 3 and 6 months
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.
Measured: at 3 and 6 months
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.
Measured: at 3 and 6 months
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.
Measured: at 3 and 6 months
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.
Measured: at 3 and 6 months
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.
Measured: at 3 and 6 months
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)
Measured: at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start15 Nov 2023
- Primary completion12 Sep 2025
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, controlled, randomized open-labelled study
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric ROCHE, PhD, Principal investigator, CHU de Saint EtienneBienvenu BONGUE, phD, Study director, Jean Monnet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787366
- Sponsor's protocol ID
- 22CH550
- Other IDs
- 2020-A00982-37
- Acronym
- SPACO+
- Status last verified
- May 2026
- First submitted
- 24 Mar 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kamdem OL, Dupre C, Heugno V, Baudot A, Essangui E, Blanquet M, Guercon N, Fanget M, Bayet S, Vericel MP, Oustric P, Mbama Biloa Y, Shikitele Lola E, Nekaa M, Debellis M, Stierlam F, Mbia RF, Tatsilong O, Assomo Ndemba P, Ngan WB, Ndobo V, Ayina Ayina C, Mekoulou J, Ndom Ebongue MS, Celarier T, Ruiz L, Regnier V, Bika C, Ngo Sack F, Ngondi JL, Barth N, Mandengue SH, Roche F, Botelho-Nevers E, Eboumbou Moukoko CE, Nguefeu Nkenfou C, Hupin D, Bongue B, Guyot J. SPACO+: a mixed methods protocol to assessing the effectiveness of an educative intervention in patients with Long Covid. BMC Infect Dis. 2025 Apr 29;25(1):623. doi: 10.1186/s12879-025-10992-6.
PubMed 40301772
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Health Pathway for People With Persistent Symptoms Covid-19
- ClinicalTrials.gov ID
- NCT05787366
- Acronym / sponsor ID
- SPACO+ / 22CH550
- Conditions
- COVID-19
- Keywords
- health pathway, quality of life, personalized multifactorial intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicenter, controlled, randomized open-labelled study
| Arm | Type | Receives |
|---|---|---|
| Usual care | Other | Other: usual care and follow-up by a nurseusual 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 | Experimental | Other: Personalized Multifactorial Intervention (IMP)usual care and Personalized Multifactorial Intervention: group benefiting from the Personalized Multifactorial Intervention coordinated by a nurse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Refused to participate in the study
- Person under legal protection
- Person with severe cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| usual care and follow-up by a nursefollow-up by a nurse and referral to a specialist(s) according to symptoms | Other | Usual care |
| Personalized Multifactorial Intervention (IMP)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. | Other | Intervention group |
Primary outcome
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.
11 secondary outcomes
impact on quality of life
Time frame: at 3 months
impact on frailty
Time frame: at 3 and 6 months
impact on comorbidities
Time frame: at 3 and 6 months
impact on dyspnea symptoms
Time frame: at 3 and 6 months
impact on hyperventilation symptoms
Time frame: at 3 and 6 months
impact on fatigue symptoms
Time frame: at 3 and 6 months
impact on neuropathic pain symptoms
Time frame: at 3 and 6 months
impact on cognitive impairment symptoms
Time frame: at 3 and 6 months
impact on musculoskeletal disorders symptoms
Time frame: at 3 and 6 months
impact on post-exertional malaise
Time frame: at 3 and 6 months
impact on anxiety and drepssion
Time frame: at 3 and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 40301772Kamdem OL, Dupre C, Heugno V, Baudot A, Essangui E, Blanquet M, Guercon N, Fanget M, Bayet S, Vericel MP, Oustric P, Mbama Biloa Y, Shikitele Lola E, Nekaa M, Debellis M, Stierlam F, Mbia RF, Tatsilong O, Assomo Ndemba P, Ngan WB, Ndobo V, Ayina Ayina C, Mekoulou J, Ndom Ebongue MS, Celarier T, Ruiz L, Regnier V, Bika C, Ngo Sack F, Ngondi JL, Barth N, Mandengue SH, Roche F, Botelho-Nevers E, Eboumbou Moukoko CE, Nguefeu Nkenfou C, Hupin D, Bongue B, Guyot J. SPACO+: a mixed methods protocol to assessing the effectiveness of an educative intervention in patients with Long Covid. BMC Infect Dis. 2025 Apr 29;25(1):623. doi: 10.1186/s12879-025-10992-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric ROCHE, PhD principal investigator
CHU de Saint Etienne
Bienvenu BONGUE, phD study director
Jean Monnet University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Multifactorial Intervention (IMP) in people with COVID-19, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the evolution of the quality of life (time frame: at the end of the 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05787366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.