Interdisciplinary Program to Improve Quality of Life in People With Fibromyalgia
Evaluation of an Optimized Interdisciplinary Program to Improve Quality of Life in People With Fibromyalgia: A Quasi-Experimental Study
Fibromyalgia is a chronic condition characterized by widespread pain, fatigue, sleep disturbances, and psychological symptoms that significantly affect quality of life. This quasi-experimental study aims to evaluate the effectiveness of the FIBROCatCentral interdisciplinary program in improving health-related quality of life among adults with fibromyalgia receiving care in Primary Care centers in Central Catalonia, Spain.
Participants in the intervention group will attend a structured multidisciplinary program consisting of 24 sessions delivered by healthcare professionals from different disciplines, including nursing, medicine, physiotherapy, nutrition, mental health, social work, and pharmacy. Outcomes will be assessed at baseline and at 3, 6, and 12 months. The primary outcome is health-related quality of life measured using the EuroQol-5D questionnaire. Secondary outcomes include fibromyalgia impact, depressive symptoms, treatment adherence, participant satisfaction, and changes in pharmacological treatment.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Fibromyalgia is a chronic syndrome characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, cognitive symptoms, and psychological distress. The condition has a substantial impact on quality of life and represents a significant burden for healthcare systems due to frequent healthcare utilization and long-term management needs.
Current evidence suggests that isolated pharmacological approaches provide limited benefits. Consequently, multidisciplinary and multicomponent non-pharmacological interventions incorporating physical activity, health education, psychological support, and self-management strategies have emerged as promising approaches for improving patient outcomes.
The FIBROCatCentral study is a quasi-experimental pre-post intervention study designed to evaluate the effectiveness of an optimized interdisciplinary program for people with fibromyalgia in Primary Care settings in Central Catalonia. The study will be conducted in Primary Care centers belonging to the Catalonia Central Health Region of the Catalan Health Institute (ICS).
Eligible participants will be adults aged 18 to 85 years with a diagnosis of fibromyalgia assigned to participating Primary Care centers. Participants choosing to participate in the intervention will be allocated to the intervention group, while those who decline participation in the program but agree to study participation will form the control group and continue receiving usual care.
The intervention consists of 24 one-hour sessions delivered by an interdisciplinary team including nurses, physicians, physiotherapists, emotional well-being professionals, nutritionists, social workers, and pharmacists. The program combines educational and practical activities aimed at improving symptom self-management, physical functioning, emotional well-being, and overall quality of life.
Data will be collected at baseline and at 3, 6, and 12 months using validated questionnaires. The primary outcome will be health-related quality of life assessed with the EuroQol-5D (EQ-5D). Secondary outcomes will include fibromyalgia impact measured with the Revised Fibromyalgia Impact Questionnaire (FIQ-R), depressive symptoms measured with the Patient Health Questionnaire-9 (PHQ-9), treatment adherence, participant satisfaction, and changes in pharmacological treatment.
The study hypothesis is that participation in the FIBROCatCentral interdisciplinary program will significantly improve quality of life and fibromyalgia-related symptoms compared with usual care.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Barcelona
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Manresa, Barcelona, Espanha, 08240
- Institut Català de la Salut - Gerència Territorial Catalunya Central
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Diagnosis of fibromyalgia.
- Age between 18 and 85 years.
- Assigned to a participating Primary Care Center in the Central Catalonia region (Bages, Berguedà, Moianès, or Calaf areas).
- Ability and willingness to provide written informed consent.
Exclusion Criteria:
- Severe mental illness.
- Current follow-up in a specialized hospital fibromyalgia unit and previous participation in a therapeutic group program for fibromyalgia.
- Inability to complete study questionnaires due to language barriers, illiteracy, or other limitations affecting reading or writing.
- Refusal or inability to provide informed consent.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Intervention
Participants will receive the FIBROCatCentral interdisciplinary program consisting of 24 one-hour sessions delivered by an interdisciplinary team including nurses, physicians, physiotherapists, emotional well-being professionals, nutritionists, social workers, and pharmacists.
The program combines educational and practical activities aimed at improving symptom self-management, quality of life, and overall well-being.
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A 24-session interdisciplinary program for people with fibromyalgia delivered by primary care healthcare professionals, including nurses, physicians, physiotherapists, emotional well-being professionals, nutritionists, social workers, and pharmacists.
The intervention combines educational and practical activities aimed at improving symptom self-management, quality of life, and overall well-being.
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Sem intervenção: Control
Participants will continue receiving usual care in Primary Care, including routine follow-up visits and pharmacological management of symptoms as determined by their healthcare professionals.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Fibromyalgia Impact
Prazo: Baseline, 3 months, 6 months, and 12 months
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Fibromyalgia impact assessed using the Revised Fibromyalgia Impact Questionnaire (FIQ-R).
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Baseline, 3 months, 6 months, and 12 months
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Health-Related Quality of Life
Prazo: Baseline, 3 months, 6 months, and 12 months
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Health-related quality of life assessed using the EuroQol-5D (EQ-5D) questionnaire.
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Baseline, 3 months, 6 months, and 12 months
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Depressive Symptoms
Prazo: Baseline, 3 months, 6 months, and 12 months
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Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9).
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Baseline, 3 months, 6 months, and 12 months
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Colaboradores e Investigadores
Publicações e links úteis
Publicações Gerais
- Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30.
- Sauch Valmana G, Miro Catalina Q, Carrasco-Querol N, Vidal-Alaball J. Gender, Mental Health and Socioeconomic Differences in Fibromyalgia: A Retrospective Cohort Study Using Real-World Data from Catalonia. Healthcare (Basel). 2023 Feb 10;11(4):530. doi: 10.3390/healthcare11040530.
- Serrat M, Almirall M, Muste M, Sanabria-Mazo JP, Feliu-Soler A, Mendez-Ulrich JL, Luciano JV, Sanz A. Effectiveness of a Multicomponent Treatment for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): A Pragmatic Randomized Controlled Trial. J Clin Med. 2020 Oct 18;9(10):3348. doi: 10.3390/jcm9103348.
- Ollevier A, Vanneuville I, Carron P, Baetens T, Goderis T, Gabriel L, Van de Velde D. A 12-week multicomponent therapy in fibromyalgia improves health but not in concomitant moderate depression, an exploratory pilot study. Disabil Rehabil. 2020 Jun;42(13):1886-1893. doi: 10.1080/09638288.2018.1543361. Epub 2019 Jan 29.
- Luciano JV, Martinez N, Penarrubia-Maria MT, Fernandez-Vergel R, Garcia-Campayo J, Verduras C, Blanco ME, Jimenez M, Ruiz JM, Lopez del Hoyo Y, Serrano-Blanco A; FibroQoL Study Group. Effectiveness of a psychoeducational treatment program implemented in general practice for fibromyalgia patients: a randomized controlled trial. Clin J Pain. 2011 Jun;27(5):383-91. doi: 10.1097/AJP.0b013e31820b131c.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- FibroCatCentral-23/199-P
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