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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile application | Experimental |
| |
| Paper booklet | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProFibro (Mobile application) | Device | ProFibro, a mobile Android application in Brazilian Portuguese to promote self-care in patients with fibromyalgia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Painful Areas Assessed With the Widespread Pain Index | Minimum value: 0. Maximum value: 19. | 6 weeks |
| Pain Assessed With the Visual Analogue Scale | Minimum value: 0. Maximum value: 10. Higher scores mean worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23604595 | Background | 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. | |
| 19369473 |
| Label | URL |
|---|---|
| The website briefly explains the stages of the development of ProFibro, the main functions of the application and the test of its efficacy. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mobile Application | The use of ProFibro mobile application for six weeks |
| FG001 | Paper Booklet | The use of a 64-page booklet (with content similar to the mobile application) for six weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mobile Application | The use of ProFibro app for 6 weeks |
| BG001 | Paper Booklet | The use of the booklet for 6 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire | Minimum value: 0. Maximum value: 100. Higher scores mean worse outcome. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mobile Application | The use of ProFibro app for 6 weeks | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amélia Pasqual Marques | School of Medicine at the University of Sao Paulo | +55 11 3091 7451 | pasqual@usp.br |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 14, 2014 | Mar 15, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Paper booklet | Device | A 64-page booklet with content similar to the mobile application |
|
| 6 weeks |
| Severity of Symptoms Assessed With the Symptom Severity Scale | Minimum value: 0. Maximum value: 12. Higher scores mean worse outcome. | 6 weeks |
| 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 |
| Adherence to Mobile Application Assessed by Number of Clicks on the App Functions | Number of clicks on the app functions | 6 weeks |
| 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. |
| 10480833 | 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. |
| 15626161 | 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. |
| 23995734 | 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. |
| 19664287 | 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. |
| 16273800 | 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. |
| 18846013 | 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. |
| 20626539 | 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. |
| 24127101 | 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. |
| 20461783 | 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. |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire | Minimum value: 0. Maximum value: 100. Higher scores mean worse outcome. | Mean | Standard Deviation | score on a scale |
|
| Number of Painful Areas Assessed With the Widespread Pain Index | Minimum value: 0. Maximum value: 19. | Mean | Standard Deviation | number of painful areas |
|
| Pain Assessed With the Visual Analogue Scale | Minimum value: 0. Maximum value: 10. Higher scores mean worse outcome. | Mean | Standard Deviation | score on a scale |
|
| Severity of Symptoms Assessed With the Symptom Severity Scale | Minimum value: 0. Maximum value: 12. Higher scores mean worse outcome. | Mean | Standard Deviation | score on a scale |
|
| Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised | Minimum value: 15. Maximum value: 75. Higher scores mean better outcome. | Mean | Standard Deviation | score on a scale |
|
| Participants |
|
|
|
| Secondary | Number of Painful Areas Assessed With the Widespread Pain Index | Minimum value: 0. Maximum value: 19. | Posted | Mean | Standard Deviation | number of painful areas | 6 weeks |
|
|
|
|
| Secondary | Pain Assessed With the Visual Analogue Scale | Minimum value: 0. Maximum value: 10. Higher scores mean worse outcome. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| Secondary | Severity of Symptoms Assessed With the Symptom Severity Scale | Minimum value: 0. Maximum value: 12. Higher scores mean worse outcome. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| Secondary | Adherence to Mobile Application Assessed by Number of Clicks on the App Functions | Number of clicks on the app functions | Posted | Median | Full Range | Clicks on app functions | 6 weeks |
|
|
|
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Paper Booklet | The use of the booklet for 6 weeks | 0 | 20 | 0 | 20 | 0 | 20 |
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| D009422 |
| Nervous System Diseases |