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SPACO+: a mixed methods protocol to assessing the effectiveness of an educative intervention in patients with Long
Odette Linda Kamdem1,2, Caroline Dupre3, Valdez Heugno4
1INSERM, SAINBIOSE, Jean Monnet University, DVH Team, U1059, Saint-Etienne, France.
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).
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