Clinical trial NCT03004911: Development of a Mobile Application to Promote Self-care in Patients With Fibromyalgia
Official title: Development of a Mobile Application to Promote Self-care in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia
mobile application
self-care
quality of life
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2016-12-29
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of Painful Areas Assessed With the Widespread Pain Index
timeFrame: 6 weeks
measure: Pain Assessed With the Visual Analogue Scale
timeFrame: 6 weeks
measure: Severity of Symptoms Assessed With the Symptom Severity Scale
timeFrame: 6 weeks
measure: Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised
timeFrame: 6 weeks
measure: Adherence to Mobile Application Assessed by Number of Clicks on the App Functions
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Department of Physical Therapy, Speech Therapy and Occupational Therapy of the School of Medicine of the University of Sao Paulo
Study officials:
affiliation: Rehabilitation Sciences PhD program of the School of Medicine of the University of Sao Paulo
name: Susan LK Yuan, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Physical Therapy, Speech Therapy and Occupational Therapy of the School of Medicine of the University of Sao Paulo
name: Amelia P Marques, PhD
role: STUDY_CHAIR
References:
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.
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.
citation: 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.
citation: 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.
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.
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.
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.
citation: 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.
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.
citation: 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.
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.