Predictive Models on Psychosocial Profile, Fatigue and Sleep Quality
ConditionFibromyalgia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity of Castilla-La Mancha
About this trial
The primary goal of this research project is to develop different prediction models in fibromyalgia disease through the application of machine learning techniques and to assess the explainability of the results. As specific objective the research project intends to evaluate the influence of psychosocial variables, fatigue, and sleep quality on the prediction of disease severity in patients with fibromyalgia using an artificial intelligence-based model.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 65 years.
Fullfilled the 2010 American Collegue of Rheumathology criteria for fibromyalgia.
Understanding of spoken and written Spanish.
Disqualifiers
Diagnosed psychiatric pathology.
Rheumatic pathology not medically controlled.
Neurological pathologies that make evaluations difficult.
Trial population
The study population will consist of adult volunteers diagnosed with fibromyalgia who meet the eligibility criteria and provide written informed consent to participate in the study. Participants will be recruited from a primary care center within the Spanish public healthcare system.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Disease severity
For this purpose, the Spanish validated version of the Fibromyalgia Impact Questionnaire (FIQ) will be used. The questionnaire comprises several components assessing physical, psychological, and social status, as well as overall well-being. It consists of 10 items scored on 0-10 scales, yielding a total score ranging from 0 to 100, with higher scores indicating greater disease impact and poorer quality of life.
Time frame
BaselineSecondary outcomes
1
Sleep quality
Sleep quality will be assessed using the Spanish validated version of the Medical Outcomes Study Sleep Scale (MOS-SS). This instrument consists of 12 items evaluating six sleep domains: sleep disturbance (ability to initiate and maintain sleep), sleep adequacy (sufficiency of sleep to feel rested), sleep quantity (number of hours of sleep), somnolence (daytime sleepiness), snoring, and shortness of breath or headache. A sleep problems index can be derived on a 0-100 scale, with higher scores indicating greater sleep-related problems.
Time frame
Baseline2
Fatigue
Fatigue severity will be assessed using the Spanish adaptation of the Multidimensional Fatigue Inventory (MFI). This is a self-administered questionnaire consisting of 20 items. It comprises five subscales that analytically assess general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. The total score ranges from 0 to 100, with higher scores indicating greater fatigue severity.
Time frame
Baseline3
Pain intensity
It will be measured with a visual analog scale (VAS) of 100 millimeters in length. The subject has to indicate the level of pain he feels, being 0 the absence of pain and 100 the maximum imaginable.
Time frame
Baseline4
Depression
Depressive symptoms will be assessed using the Spanish adaptation of the Beck Depression Inventory-II (BDI-II). This instrument consists of 21 items designed to measure affective and cognitive status, as well as the signs and symptoms of depression experienced over the preceding two weeks. Total scores range from 0 to 63, where higher scores indicate greater severity.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Castilla-La Mancha
Lead sponsor
Tampere University
Collaborator
Andaluz Health Service
Collaborator
Source ClinicalTrials.gov
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