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

NCT03004911 | Completed Results

• 1 other identifier: 274/14
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

fibromyalgia; mobile application; self-care; quality of life

Outcome Measures

Primary Outcomes (1)

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

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

  6 weeks

Secondary Outcomes (5)

• Number of Painful Areas Assessed With the Widespread Pain Index

  6 weeks

• Pain Assessed With the Visual Analogue Scale

  6 weeks

• Severity of Symptoms Assessed With the Symptom Severity Scale

  6 weeks

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

  6 weeks

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

  6 weeks

Study Arms (2)

Mobile application

EXPERIMENTAL

Device: ProFibro (Mobile application)

Paper booklet

ACTIVE COMPARATOR

Device: Paper booklet

Interventions

ProFibro (Mobile application) DEVICE

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

Mobile application

Paper booklet DEVICE

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

Paper booklet

Eligibility Criteria

• Age: 19 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosis of fibromyalgia, according to the 2010 American College of Rheumatology diagnostic criteria
• smartphone user
• complete primary education

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

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

Location

Related Publications (11)

• Paiva ES, Heymann RE, Rezende MC, Helfenstein M Jr, Martinez JE, Provenza JR, Ranzolin A, de Assis MR, Pasqualin VD, Bennett RM. A Brazilian Portuguese version of the Revised Fibromyalgia Impact Questionnaire (FIQR): a validation study. Clin Rheumatol. 2013 Aug;32(8):1199-206. doi: 10.1007/s10067-013-2259-6. Epub 2013 Apr 21.

  PMID: 23604595 BACKGROUND

• Bennett RM, Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky AB. Minimal clinically important difference in the fibromyalgia impact questionnaire. J Rheumatol. 2009 Jun;36(6):1304-11. doi: 10.3899/jrheum.081090. Epub 2009 Apr 15.

  PMID: 19369473 BACKGROUND

• Altman DG, Bland JM. How to randomise. BMJ. 1999 Sep 11;319(7211):703-4. doi: 10.1136/bmj.319.7211.703. No abstract available.

  PMID: 10480833 BACKGROUND

• Henriksson C, Carlberg U, Kjallman M, Lundberg G, Henriksson KG. Evaluation of four outpatient educational programmes for patients with longstanding fibromyalgia. J Rehabil Med. 2004 Sep;36(5):211-9. doi: 10.1080/16501970410027494.

  PMID: 15626161 BACKGROUND

• Nam S, Tin D, Bain L, Thorne JC, Ginsburg L. Clinical utility of the Hospital Anxiety and Depression Scale (HADS) for an outpatient fibromyalgia education program. Clin Rheumatol. 2014 May;33(5):685-92. doi: 10.1007/s10067-013-2377-1. Epub 2013 Sep 1.

  PMID: 23995734 BACKGROUND

• Bennett RM, Friend R, Jones KD, Ward R, Han BK, Ross RL. The Revised Fibromyalgia Impact Questionnaire (FIQR): validation and psychometric properties. Arthritis Res Ther. 2009;11(4):R120. doi: 10.1186/ar2783. Epub 2009 Aug 10.

  PMID: 19664287 BACKGROUND

• Bennett R. The Fibromyalgia Impact Questionnaire (FIQ): a review of its development, current version, operating characteristics and uses. Clin Exp Rheumatol. 2005 Sep-Oct;23(5 Suppl 39):S154-62.

  PMID: 16273800 BACKGROUND

• Marques AP, Assumpcao A, Matsutani LA, Pereira CA, Lage L. Pain in fibromyalgia and discrimination power of the instruments: Visual Analog Scale, Dolorimetry and the McGill Pain Questionnaire. Acta Reumatol Port. 2008 Jul-Sep;33(3):345-51.

  PMID: 18846013 BACKGROUND

• Sousa VD, Zauszniewski JA, Bergquist-Beringer S, Musil CM, Neese JB, Jaber AF. Reliability, validity and factor structure of the Appraisal of Self-Care Agency Scale-Revised (ASAS-R). J Eval Clin Pract. 2010 Dec;16(6):1031-40. doi: 10.1111/j.1365-2753.2009.01242.x.

  PMID: 20626539 BACKGROUND

• Damasio BF, Koller SH. The Appraisal of Self-Care Agency Scale - Revised (ASAS-R): adaptation and construct validity in the Brazilian context. Cad Saude Publica. 2013 Oct;29(10):2071-82. doi: 10.1590/0102-311x00165312.

  PMID: 24127101 BACKGROUND

• Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.

  PMID: 20461783 BACKGROUND

Related Links

• The website briefly explains the stages of the development of ProFibro, the main functions of the application and the test of its efficacy.

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Amélia Pasqual Marques
• Organization: School of Medicine at the University of Sao Paulo

pasqual@usp.br

+55 11 3091 7451

Study Officials

• Susan LK Yuan, MSc

  Rehabilitation Sciences PhD program of the School of Medicine of the University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: December 29, 2016
• Study Start: February 14, 2017
• Primary Completion: December 12, 2017
• Study Completion: December 12, 2017
• Last Updated: June 17, 2019
• Results First Posted: June 17, 2019

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)