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Trial record 22 of 275 for:    quality | "Fibromyalgia"

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

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ClinicalTrials.gov Identifier: NCT03004911
Recruitment Status : Completed
First Posted : December 29, 2016
Last Update Posted : May 30, 2018
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

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: Change from baseline at 6 weeks ]
    The Revised Fibromyalgia Impact Questionnaire


Secondary Outcome Measures :
  1. Pain assessed with the Widespread Pain Index [ Time Frame: Change from baseline at 6 weeks ]
    Widespread Pain Index

  2. Pain assessed with the Visual Analogue Scale [ Time Frame: Change from baseline at 6 weeks ]
    Visual Analogue Scale

  3. Severity of symptoms assessed with the Symptom Severity Scale [ Time Frame: Change from baseline at 6 weeks ]
    Symptom Severity Scale

  4. Self-care agency assessed with the Appraisal of Self-Care Agency Scale - Revised [ Time Frame: Change from baseline at 6 weeks ]
    Appraisal of Self-Care Agency Scale - Revised

  5. Adherence to mobile application assessed by number of clicks on the app functions [ Time Frame: At 6 weeks ]
    Number of clicks on the app functions



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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
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
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

Additional Information:
Publications:

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
Last Update Posted: May 30, 2018
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases