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OpenTrials
Completed

NCT Number: NCT03004911

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

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

19 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Therapy, Speech Therapy and Occupational Therapy of the School of Medicine of the University of Sao Paulo

São Paulo, 05360-160, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ProFibro (Mobile application)

Device

ProFibro, a mobile Android application in Brazilian Portuguese to promote self-care in patients with fibromyalgia

Paper booklet

Device

A 64-page booklet with content similar to the mobile application

Primary outcomes

  1. Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire

    Time frame: 6 weeks

    Minimum value: 0. Maximum value: 100. Higher scores mean worse outcome.

Secondary outcomes

  1. Number of Painful Areas Assessed With the Widespread Pain Index

    Time frame: 6 weeks

    Minimum value: 0. Maximum value: 19.

  2. Pain Assessed With the Visual Analogue Scale

    Time frame: 6 weeks

    Minimum value: 0. Maximum value: 10. Higher scores mean worse outcome.

  3. Severity of Symptoms Assessed With the Symptom Severity Scale

    Time frame: 6 weeks

    Minimum value: 0. Maximum value: 12. Higher scores mean worse outcome.

  4. Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised

    Time frame: 6 weeks

    Minimum value: 15. Maximum value: 75. Higher scores mean better outcome.

  5. Adherence to Mobile Application Assessed by Number of Clicks on the App Functions

    Time frame: 6 weeks

    Number of clicks on the app functions

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 29, 2016
Registry last updated
Jun 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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