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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03004911
• Other study ID #: 274/14
• Status: Completed
• Phase: N/A
• Start date: February 14, 2017
• Est. completion date: December 12, 2017

Study information

• Verified date: December 2016
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 12, 2017
• Est. primary completion date: December 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• ProFibro (Mobile application)
ProFibro, a mobile Android application in Brazilian Portuguese to promote self-care in patients with fibromyalgia
• Paper booklet
A 64-page booklet with content similar to the mobile application

Locations

Country	Name	City	State
Brazil	Department of Physical Therapy, Speech Therapy and Occupational Therapy of the School of Medicine of the University of Sao Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (11)

Altman DG, Bland JM. How to randomise. BMJ. 1999 Sep 11;319(7211):703-4. Review. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: Arthritis Res Ther. 2009;11(5):415. — View Citation

Damásio 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. — View Citation

Henriksson C, Carlberg U, Kjällman 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. — View Citation

Marques AP, Assumpção 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Painful Areas Assessed With the Widespread Pain Index	Minimum value: 0. Maximum value: 19.	6 weeks
Secondary	Pain Assessed With the Visual Analogue Scale	Minimum value: 0. Maximum value: 10. Higher scores mean worse outcome.	6 weeks
Secondary	Severity of Symptoms Assessed With the Symptom Severity Scale	Minimum value: 0. Maximum value: 12. Higher scores mean worse outcome.	6 weeks
Secondary	Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised	Minimum value: 15. Maximum value: 75. Higher scores mean better outcome.	6 weeks
Secondary	Adherence to Mobile Application Assessed by Number of Clicks on the App Functions	Number of clicks on the app functions	6 weeks

External Links

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