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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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Barcelona
      • Manresa, Barcelona, Spania, 08240
        • Institut Català de la Salut - Gerència Territorial Catalunya Central

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
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.
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fibromyalgia Impact
Tidsramme: Baseline, 3 months, 6 months, and 12 months
Fibromyalgia impact assessed using the Revised Fibromyalgia Impact Questionnaire (FIQ-R).
Baseline, 3 months, 6 months, and 12 months
Health-Related Quality of Life
Tidsramme: Baseline, 3 months, 6 months, and 12 months
Health-related quality of life assessed using the EuroQol-5D (EQ-5D) questionnaire.
Baseline, 3 months, 6 months, and 12 months
Depressive Symptoms
Tidsramme: Baseline, 3 months, 6 months, and 12 months
Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9).
Baseline, 3 months, 6 months, and 12 months

Samarbeidspartnere og etterforskere

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Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. november 2024

Primær fullføring (Faktiske)

21. mai 2026

Studiet fullført (Faktiske)

21. mai 2026

Datoer for studieregistrering

Først innsendt

10. juni 2026

Først innsendt som oppfylte QC-kriteriene

16. juni 2026

Først lagt ut (Faktiske)

22. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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