Effect of Bei App for Fibromyalgia

Официальное название

Effect of an mHealth-based Digital Intervention to Support Multimodal Treatment in Patients With Fibromyalgia.

Обзор

Background: Fibromyalgia (FM) is a complex, chronic condition characterized by widespread musculoskeletal pain, cognitive dysfunction, fatigue, and emotional comorbidities such as anxiety and depression. These symptoms severely impact daily functioning and quality of life. Although non-pharmacological strategies-such as therapeutic exercise and patient education-are recommended as first-line treatments, their implementation outside the clinical setting remains a challenge due to low adherence and lack of continuity. Objective: To evaluate the effectiveness of a digital health intervention-BEI app-as a complement to usual care in improving clinical and functional outcomes among patients with fibromyalgia. Methods: This is a randomized controlled trial (RCT) with two parallel arms (1:1 allocation). A total of 70 adult participants with fibromyalgia (diagnosed per ACR 2016 criteria) will be recruited through a patient association in Madrid, Spain. The control group will receive 12 weeks of standard, in-person treatment consisting of group-based education and physical activity. The experimental group will receive the same in-person program plus daily access to the BEI mobile application, which includes educational modules, physical and cognitive training, symptom tracking, and personalized feedback. Outcomes will be assessed at baseline, week 6 (mid-intervention), week 12 (post-intervention), and week 24 (follow-up). Primary outcomes include pain intensity (VAS) and functional impact (FIQR). Secondary outcomes include catastrophizing, self-efficacy, cognitive function, physical activity, anxiety, depression, quality of life, app engagement, and satisfaction. Expected results: The results of this trial will provide evidence regarding the potential of mHealth tools to enhance adherence, self-efficacy, and functional outcomes in individuals with fibromyalgia.

Вмешательства

• Устройство Mobile App + psychoeducation program
  Participants will attend 12 weekly group sessions, each lasting one hour, focused on psychoeducation. In addition to that, participants will receive access to the BEI mobile app, designed to reinforce education and exercise strategies outside clinical sessions. Participants will be instructed to use the app daily, guided by a to-do list including: * 1 educational module (interactive format) + 3 questions self-exam * 1 physical activity (video-guided, adapted by fatigue and pain level) * 1 gamif
• Поведенческое Psychoeducation program
  Participants will attend 12 weekly group sessions, each lasting one hour, focused on psychoeducation.

Первичные конечные точки

• Pain Intensity [Срок оценки: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)]
• Functional Impact [Срок оценки: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)]

Вторичные конечные точки (12)

• Pain Catastrophizing [Срок оценки: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)]
• Self-Efficacy [Срок оценки: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)]
• Cognitive Function [Срок оценки: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)]
• Physical Activity [Срок оценки: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)]
• Kinesiophobia [Срок оценки: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)]
• Anxiety [Срок оценки: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)]
• Depression [Срок оценки: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)]
• Quality of Life EQ-5D [Срок оценки: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)]
• Digital Literacy [Срок оценки: Baseline (week 0)]
• App Engagement: Frequency of App Use [Срок оценки: final of the treatment (week 12) and follow up (24 week)]
• App Engagement: Session Length [Срок оценки: final of the treatment (week 12) and follow up (24 week)]
• App Engagement: Completion of Logs [Срок оценки: final of the treatment (week 12) and follow up (24 week)]

Критерии участия

Критерии включения

• Participants will be adults between 18 and 65 years of age with a clinical diagnosis of fibromyalgia according to the 2016 criteria established by the American College of Rheumatology (ACR).
• All participants must be actively enrolled in the group sessions offered by the patient association and possess the ability to use a smartphone or tablet compatible with the BEI app.
• Informed consent must be provided voluntarily.
• Additionally, participants are required to have a minimum level of digital health literacy, operationalized as a score equal to or greater than 2.5 in at least four dimensions of the eHealth Literacy Questionnaire (eHLQ).

Критерии исключения

• Participants will be excluded if they present with severe or unstable psychiatric disorders, such as schizophrenia or uncontrolled major depression.
• Other exclusion criteria include medical comorbidities that contraindicate physical activity, current pregnancy, or concurrent participation in another digital health program or the use of similar therapeutic applications.
• Individuals with cognitive impairments or technological limitations that prevent the use of the app or participation in digital assessments will also be excluded.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07090434 · BEI.APP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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