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N/A Completed N=40 Randomized Single-blind Treatment

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

Source: ClinicalTrials.gov NCT03004911 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire — 53.7; 55.5 score on a scale — p=0.740

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.

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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