Development of a Mobile Application to Promote Self-care in Patients With Fibromyalgia

Study Overview
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Brief Summary
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The purpose of this study is to test the efficacy of a mobile application named ProFibro to promote self-care, and improve symptoms and health-related quality of life in Brazilian patients with fibromyalgia.

Official Title
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Development of a Mobile Application to Promote Self-care in Patients With Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: ProFibro (Mobile application)
* Device: Paper booklet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of fibromyalgia, according to the 2010 American College of Rheumatology diagnostic criteria smartphone user complete primary education Exclusion Criteria: being in physical therapy treatment for fibromyalgia or having been treated in the last 3 months diagnosis of other chronic pain conditions (neuropathies, rheumatoid arthritis, osteoarthritis, spinal stenosis or cancer) severe mental disorders (schizophrenia, psychosis, bipolar affective disorder, severe depression) moderate or severe intellectual disability hearing or visual impairment

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile application<br> | Device: ProFibro (Mobile application)<br>* ProFibro, a mobile Android application in Brazilian Portuguese to promote self-care in patients with fibromyalgia<br>|
| Active Comparator: Paper booklet<br> | Device: Paper booklet<br>* A 64-page booklet with content similar to the mobile application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire | Minimum value: 0. Maximum value: 100. Higher scores mean worse outcome. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Painful Areas Assessed With the Widespread Pain Index | Minimum value: 0. Maximum value: 19. | 6 weeks | 
| Pain Assessed With the Visual Analogue Scale | Minimum value: 0. Maximum value: 10. Higher scores mean worse outcome. | 6 weeks | 
| Severity of Symptoms Assessed With the Symptom Severity Scale | Minimum value: 0. Maximum value: 12. Higher scores mean worse outcome. | 6 weeks | 
| Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised | Minimum value: 15. Maximum value: 75. Higher scores mean better outcome. | 6 weeks | 
| Adherence to Mobile Application Assessed by Number of Clicks on the App Functions | Number of clicks on the app functions | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibromyalgia, mobile application, self-care, quality of life