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

March 18, 2019 updated by: University of Sao Paulo General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05360-160
        • Department of Physical Therapy, Speech Therapy and Occupational Therapy of the School of Medicine of the University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Painful Areas Assessed With the Widespread Pain Index
Time Frame: 6 weeks
Minimum value: 0. Maximum value: 19.
6 weeks
Pain Assessed With the Visual Analogue Scale
Time Frame: 6 weeks
Minimum value: 0. Maximum value: 10. Higher scores mean worse outcome.
6 weeks
Severity of Symptoms Assessed With the Symptom Severity Scale
Time Frame: 6 weeks
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
Time Frame: 6 weeks
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
Time Frame: 6 weeks
Number of clicks on the app functions
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Susan LK Yuan, MSc, Rehabilitation Sciences PhD program of the School of Medicine of the University of Sao Paulo
  • Study Chair: Amelia P Marques, PhD, Department of Physical Therapy, Speech Therapy and Occupational Therapy of the School of Medicine of the University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2017

Primary Completion (Actual)

December 12, 2017

Study Completion (Actual)

December 12, 2017

Study Registration Dates

First Submitted

December 21, 2016

First Submitted That Met QC Criteria

December 23, 2016

First Posted (Estimate)

December 29, 2016

Study Record Updates

Last Update Posted (Actual)

June 17, 2019

Last Update Submitted That Met QC Criteria

March 18, 2019

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 274/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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