Effect of an mHealth-based Digital Intervention to Support Multimodal Treatment in Patients With Fibromyalgia.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 70
- Primary Endpoint
- Pain Intensity
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Pain Intensity
Time Frame: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)
Pain intensity will be measured using a 100 mm Numeric Rating Scale (NRS), where 0 represents "no pain" and 100 represents the "worst pain imaginable." Participants will mark a point on the line that best reflected the pain they were experiencing at the time of measurement. Higher scores indicated higher levels of pain, and the administration required less than one minute
Functional Impact
Time Frame: Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24)
It will be measured using the Revised Fibromyalgia Impact Questionnaire (FIQR), a tool designed to assess the impact of fibromyalgia on patients' daily lives. The FIQR consists of 21 items that evaluate various dimensions, including physical functioning, symptom severity, general health, and pain perception. Items are scored on a scale from 0 to 10, with higher scores indicating a greater impact of the disease. It has demonstrated high internal consistency, with a Cronbach's alpha ranging from 0.91 to 0.95
Secondary Outcomes
- Pain Catastrophizing(Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24))
- Self-Efficacy(Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24))
- Cognitive Function(Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24))
- Physical Activity(Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24))
- Kinesiophobia(Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24))
- Anxiety(Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24))
- Depression(Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24))
- Quality of Life EQ-5D(Baseline (week 0) - half treatment (week 6) - end of the treatment (week 12) - follow up (week 24))
- Digital Literacy(Baseline (week 0))
- App Engagement: Frequency of App Use(final of the treatment (week 12) and follow up (24 week))
- App Engagement: Session Length(final of the treatment (week 12) and follow up (24 week))
- App Engagement: Completion of Logs(final of the treatment (week 12) and follow up (24 week))
- App Engagement: Completion of Modules(final of the treatment (week 12) and follow up (24 week))
Investigators
Raúl Ferrer-Peña
Dr
Universidad Autonoma de Madrid