N/A
N=40
Development of a Mobile Application to Promote Self-care in Patients With Fibromyalgia
Fibromyalgia
Bottom Line
View on ClinicalTrials.gov: NCT03004911 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire — 53.7; 55.5 score on a scale — p=0.740
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ProFibro (Mobile application) (Device); Paper booklet (Device)
- Age
- Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Sao Paulo General Hospital
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire |
53.7; 55.5 | 0.740 |
| SECONDARY Number of Painful Areas Assessed With the Widespread Pain Index |
12.5; 12.3 | 0.890 |
| SECONDARY Pain Assessed With the Visual Analogue Scale |
5.1; 5.3 | 0.747 |
| SECONDARY Severity of Symptoms Assessed With the Symptom Severity Scale |
7.6; 7.6 | 1.000 |
| SECONDARY Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised |
56.8; 54.3 | 0.459 |
| SECONDARY Adherence to Mobile Application Assessed by Number of Clicks on the App Functions |
106 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03004911). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.