SPACO+: a mixed methods protocol to assessing the effectiveness of an educative intervention in patients with Long Covid
Abstract Background The management of many chronic diseases requires a multidisciplinary and holistic approach. Long Covid is a recent, poorly understood disease with several symptoms. Most recommendations suggest a multidisciplinary approach. While there are a few programs aimed to the management o...
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2025-04-01
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| Online Access: | https://doi.org/10.1186/s12879-025-10992-6 |
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| author | Odette Linda Kamdem Caroline Dupre Valdez Heugno Amandine Baudot Estelle Essangui Marie Blanquet Nina Guercon Marie Fanget Sasha Bayet Marie Pierre Vericel Pauline Oustric Yves Mbama Biloa Elie Shikitele Lola Mabrouk Nekaa Mario Debellis François Stierlam Ronelle Fabiola Mbia Olivier Tatsilong Peguy Assomo Ndemba Williams Bell Ngan Valérie Ndobo Clarisse Ayina Ayina Jerson Mekoulou Marie Solange Ndom Ebongue Thomas Celarier Louise Ruiz Veronique Regnier Claude Bika Françoise Ngo Sack Judith Laure Ngondi Nathalie Barth Samuel Honore Mandengue Frederic Roche Elisabeth Botelho-nevers Carole Else Eboumbou Moukoko Céline Nguefeu Nkenfou David Hupin Bienvenu Bongue Jessica Guyot |
| author_facet | Odette Linda Kamdem Caroline Dupre Valdez Heugno Amandine Baudot Estelle Essangui Marie Blanquet Nina Guercon Marie Fanget Sasha Bayet Marie Pierre Vericel Pauline Oustric Yves Mbama Biloa Elie Shikitele Lola Mabrouk Nekaa Mario Debellis François Stierlam Ronelle Fabiola Mbia Olivier Tatsilong Peguy Assomo Ndemba Williams Bell Ngan Valérie Ndobo Clarisse Ayina Ayina Jerson Mekoulou Marie Solange Ndom Ebongue Thomas Celarier Louise Ruiz Veronique Regnier Claude Bika Françoise Ngo Sack Judith Laure Ngondi Nathalie Barth Samuel Honore Mandengue Frederic Roche Elisabeth Botelho-nevers Carole Else Eboumbou Moukoko Céline Nguefeu Nkenfou David Hupin Bienvenu Bongue Jessica Guyot |
| author_sort | Odette Linda Kamdem |
| collection | DOAJ |
| description | Abstract Background The management of many chronic diseases requires a multidisciplinary and holistic approach. Long Covid is a recent, poorly understood disease with several symptoms. Most recommendations suggest a multidisciplinary approach. While there are a few programs aimed to the management of Long Covid, to our knowledge very few were assessed. The SPACO + study therefore aims to evaluate an innovative program which combines the methods used in therapeutic education and in personalized multifactorial intervention for management of Long Covid. Here, we present the protocol of our study, which aims to evaluate the effectiveness of an educational intervention in terms of changes in quality of life at 6 months in comparison with standard clinical practice in patients suffering from Long Covid. Methods To achieve our objectives, we have planned to carry out a prospective, multicentre, two-arm randomized controlled trial with a convergent parallel mixed methods design. Two countries are involved in this study: France and Cameroon. The study concerns patients aged 18 and over, who have been infected with Covid-19. They must also be diagnosed as having Long Covid in accordance with the WHO definition. The number of subjects required for the study is 400 individuals. Participants will be randomly assigned to either the intervention or control group using a dynamic randomization process to ensure balanced group characteristics. The SPACO + program is an educative intervention with individual follow-up by a nurse dedicated to the program. The SPACO + program offers five workshops, two of which are compulsories. Patients take part in the other workshops according to their needs. The program includes an 8 – 10 weeks intervention period. Each session lasts two hours and includes breaks (pacing). The main outcome measure will be quality of life, evaluated through the SF-36. Primary and secondary outcomes, with few exceptions, are assessed before the intervention (“T0”), at 8 weeks (“T1” corresponding to the end of SPACO + program’s session period) and then 3 months later (“T2”). Discussion If the SPACO + program is effective and accepted by professionals and patients, it could be disseminated in other regions to assess its transferability. The medico-economic evaluation will also make it possible to assess the benefits provided. Trial registration This trial is registered under the number NCT05787366 (March 24, 2023). Protocol Version N°3.0 (May 31, 2024) |
| format | Article |
| id | doaj-art-0355af27b0df445c8dab6e5ab7dfe6b9 |
| institution | DOAJ |
| issn | 1471-2334 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | BMC |
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| series | BMC Infectious Diseases |
| spelling | doaj-art-0355af27b0df445c8dab6e5ab7dfe6b92025-08-20T02:55:35ZengBMCBMC Infectious Diseases1471-23342025-04-0125111210.1186/s12879-025-10992-6SPACO+: a mixed methods protocol to assessing the effectiveness of an educative intervention in patients with Long CovidOdette Linda Kamdem0Caroline Dupre1Valdez Heugno2Amandine Baudot3Estelle Essangui4Marie Blanquet5Nina Guercon6Marie Fanget7Sasha Bayet8Marie Pierre Vericel9Pauline Oustric10Yves Mbama Biloa 11Elie Shikitele Lola12Mabrouk Nekaa13Mario Debellis14François Stierlam15Ronelle Fabiola Mbia16Olivier Tatsilong17Peguy Assomo Ndemba18Williams Bell Ngan19Valérie Ndobo20Clarisse Ayina Ayina21Jerson Mekoulou22Marie Solange Ndom Ebongue23Thomas Celarier24Louise Ruiz25Veronique Regnier26Claude Bika27Françoise Ngo Sack28Judith Laure Ngondi29Nathalie Barth30Samuel Honore Mandengue31Frederic Roche32Elisabeth Botelho-nevers33Carole Else Eboumbou Moukoko34Céline Nguefeu Nkenfou35David Hupin36Bienvenu Bongue37Jessica Guyot38INSERM, SAINBIOSE, Jean Monnet UniversityINSERM, University Hospital CentrePhysical Activities and Sport Physiology and Medicine Unit, University of DoualaINSERM, University Hospital CentreFaculty of Medicine and Pharmaceutical Sciences, University of DoualaCHU Clermont-FerrandINSERM, University Hospital CentreDepartment of Clinical and Exercise Physiology, University Hospital of Saint-EtienneDepartment of Clinical and Exercise Physiology, University Hospital of Saint-EtienneDepartment of Clinical and Exercise Physiology, University Hospital of Saint-EtienneApresj20, Association Covid Long FranceINSERM, SAINBIOSE, Jean Monnet UniversityCaisse Primaire d’Assurance Maladie (CPAM 42)Education Culture Politique (EA 4571) , University Lyon 2Dispositif d’Appui à la Coordination Loire (DAC Loire)Dispositif d’Appui à la Coordination Loire (DAC Loire)PRESAGE Institute, Jean Monnet UniversityINSERM, SAINBIOSE, Jean Monnet UniversityFaculty of Medicine and Biomedical Sciences, University of Yaounde 1INSERM, SAINBIOSE, Jean Monnet UniversityFaculty of Medicine and Biomedical Sciences, University of Yaounde 1Physical Activities and Sport Physiology and Medicine Unit, University of DoualaPhysical Activities and Sport Physiology and Medicine Unit, University of DoualaFaculty of Medicine and Pharmaceutical Sciences, University of DoualaDépartement de Gérontologie Clinique, CHU de Saint-ÉtienneURPS Infirmiers Auvergne Rhône AlpesPRESAGE Institute, Jean Monnet UniversityPhysical Activities and Sport Physiology and Medicine Unit, University of DoualaPhysical Activities and Sport Physiology and Medicine Unit, University of DoualaFaculty of Medicine and Biomedical Sciences, University of Yaounde 1Gérontopole AURAPhysical Activities and Sport Physiology and Medicine Unit, University of DoualaINSERM, SAINBIOSE, Jean Monnet UniversityPRESAGE Institute, Jean Monnet UniversityFaculty of Medicine and Pharmaceutical Sciences, University of DoualaSystems Biology Laboratory, Chantal Biya International Reference CentreINSERM, SAINBIOSE, Jean Monnet UniversityINSERM, SAINBIOSE, Jean Monnet UniversityINSERM, SAINBIOSE, Jean Monnet UniversityAbstract Background The management of many chronic diseases requires a multidisciplinary and holistic approach. Long Covid is a recent, poorly understood disease with several symptoms. Most recommendations suggest a multidisciplinary approach. While there are a few programs aimed to the management of Long Covid, to our knowledge very few were assessed. The SPACO + study therefore aims to evaluate an innovative program which combines the methods used in therapeutic education and in personalized multifactorial intervention for management of Long Covid. Here, we present the protocol of our study, which aims to evaluate the effectiveness of an educational intervention in terms of changes in quality of life at 6 months in comparison with standard clinical practice in patients suffering from Long Covid. Methods To achieve our objectives, we have planned to carry out a prospective, multicentre, two-arm randomized controlled trial with a convergent parallel mixed methods design. Two countries are involved in this study: France and Cameroon. The study concerns patients aged 18 and over, who have been infected with Covid-19. They must also be diagnosed as having Long Covid in accordance with the WHO definition. The number of subjects required for the study is 400 individuals. Participants will be randomly assigned to either the intervention or control group using a dynamic randomization process to ensure balanced group characteristics. The SPACO + program is an educative intervention with individual follow-up by a nurse dedicated to the program. The SPACO + program offers five workshops, two of which are compulsories. Patients take part in the other workshops according to their needs. The program includes an 8 – 10 weeks intervention period. Each session lasts two hours and includes breaks (pacing). The main outcome measure will be quality of life, evaluated through the SF-36. Primary and secondary outcomes, with few exceptions, are assessed before the intervention (“T0”), at 8 weeks (“T1” corresponding to the end of SPACO + program’s session period) and then 3 months later (“T2”). Discussion If the SPACO + program is effective and accepted by professionals and patients, it could be disseminated in other regions to assess its transferability. The medico-economic evaluation will also make it possible to assess the benefits provided. Trial registration This trial is registered under the number NCT05787366 (March 24, 2023). Protocol Version N°3.0 (May 31, 2024)https://doi.org/10.1186/s12879-025-10992-6Long CovidHealth pathwayQuality of lifeEducative interventionRandomized controlled trialMixed methods |
| spellingShingle | Odette Linda Kamdem Caroline Dupre Valdez Heugno Amandine Baudot Estelle Essangui Marie Blanquet Nina Guercon Marie Fanget Sasha Bayet Marie Pierre Vericel Pauline Oustric Yves Mbama Biloa Elie Shikitele Lola Mabrouk Nekaa Mario Debellis François Stierlam Ronelle Fabiola Mbia Olivier Tatsilong Peguy Assomo Ndemba Williams Bell Ngan Valérie Ndobo Clarisse Ayina Ayina Jerson Mekoulou Marie Solange Ndom Ebongue Thomas Celarier Louise Ruiz Veronique Regnier Claude Bika Françoise Ngo Sack Judith Laure Ngondi Nathalie Barth Samuel Honore Mandengue Frederic Roche Elisabeth Botelho-nevers Carole Else Eboumbou Moukoko Céline Nguefeu Nkenfou David Hupin Bienvenu Bongue Jessica Guyot SPACO+: a mixed methods protocol to assessing the effectiveness of an educative intervention in patients with Long Covid BMC Infectious Diseases Long Covid Health pathway Quality of life Educative intervention Randomized controlled trial Mixed methods |
| title | SPACO+: a mixed methods protocol to assessing the effectiveness of an educative intervention in patients with Long Covid |
| title_full | SPACO+: a mixed methods protocol to assessing the effectiveness of an educative intervention in patients with Long Covid |
| title_fullStr | SPACO+: a mixed methods protocol to assessing the effectiveness of an educative intervention in patients with Long Covid |
| title_full_unstemmed | SPACO+: a mixed methods protocol to assessing the effectiveness of an educative intervention in patients with Long Covid |
| title_short | SPACO+: a mixed methods protocol to assessing the effectiveness of an educative intervention in patients with Long Covid |
| title_sort | spaco a mixed methods protocol to assessing the effectiveness of an educative intervention in patients with long covid |
| topic | Long Covid Health pathway Quality of life Educative intervention Randomized controlled trial Mixed methods |
| url | https://doi.org/10.1186/s12879-025-10992-6 |
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