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Trial record 3 of 104 for:    fibromyalgia | Open Studies | Interventional Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by University of Sao Paulo General Hospital
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT03004911
First received: December 21, 2016
Last updated: May 15, 2017
Last verified: December 2016
  Purpose
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 Intervention
Fibromyalgia
Device: ProFibro (Mobile application)
Device: Paper booklet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: Development of a Mobile Application to Promote Self-care in Patients With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • 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:
  • Pain assessed with the Widespread Pain Index [ Time Frame: Change from baseline at 6 weeks ]
    Widespread Pain Index

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

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

  • 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

  • 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


Estimated Enrollment: 40
Actual Study Start Date: February 14, 2017
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03004911

Contacts
Contact: Susan LK Yuan, MSc +55 11 99582 9007 susanlkyuan@gmail.com
Contact: Amelia P Marques, PhD +55 11 3091 8423 pasqual@usp.br

Locations
Brazil
Department of Physical Therapy, Speech Therapy and Occupational Therapy of the School of Medicine of the University of Sao Paulo Recruiting
Sao Paulo, Brazil, 05360-160
Contact: Susan LK Yuan, MSc    +55 11 3091 8423    susanlkyuan@gmail.com   
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
  More Information

Additional Information:
Publications:

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03004911     History of Changes
Other Study ID Numbers: 274/14
Study First Received: December 21, 2016
Last Updated: May 15, 2017
Individual Participant Data  
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

ClinicalTrials.gov processed this record on May 25, 2017