Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03004911
Recruitment Status : Completed
First Posted : December 29, 2016
Results First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Device: ProFibro (Mobile application) Device: Paper booklet Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development of a Mobile Application to Promote Self-care in Patients With Fibromyalgia
Actual Study Start Date : February 14, 2017
Actual Primary Completion Date : December 12, 2017
Actual Study Completion Date : December 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03004911


Locations
Layout table for location information
Brazil
Department of Physical Therapy, Speech Therapy and Occupational Therapy of the School of Medicine of the University of Sao Paulo
Sao Paulo, Brazil, 05360-160
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Layout table for investigator information
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
  Study Documents (Full-Text)

Documents provided by University of Sao Paulo General Hospital:

Additional Information:
Publications:

Layout table for additonal information
Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03004911     History of Changes
Other Study ID Numbers: 274/14
First Posted: December 29, 2016    Key Record Dates
Results First Posted: June 17, 2019
Last Update Posted: June 17, 2019
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Sao Paulo General Hospital:
fibromyalgia
mobile application
self-care
quality of life

Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases