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

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Device: ProFibro (Mobile application); Device: Paper booklet

• Registration Number: NCT03004911
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-12
• Study First Submitted: 2016-12-21
• Study First Submitted QC: 2016-12-23
• Study First Posted: 2016-12-29
• Study Start: 2017-02-14
• Primary Completion: 2017-12-12
• Study Completion: 2017-12-12
• Results First Submitted: 2018-12-04
• Results First Submitted QC: 2019-03-18
• Last Update Submitted: 2019-03-18
• Results First Posted: 2019-06-17
• Last Update Posted: 2019-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobile application	ProFibro (Mobile application)	-
Paper booklet	Paper booklet	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Physical Therapy, Speech Therapy and Occupational Therapy of the School of Medicine of the University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil