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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
ProFibro (Mobile application)
Paper booklet
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, mobile application, self-care, quality of life

Eligibility Criteria

19 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Physical Therapy, Speech Therapy and Occupational Therapy of the School of Medicine of the University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mobile application

Paper booklet

Arm Description

Outcomes

Primary Outcome Measures

Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire
Minimum value: 0. Maximum value: 100. Higher scores mean worse outcome.

Secondary Outcome Measures

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

Full Information

First Posted
December 21, 2016
Last Updated
March 18, 2019
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03004911
Brief Title
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

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
February 14, 2017 (Actual)
Primary Completion Date
December 12, 2017 (Actual)
Study Completion Date
December 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia, mobile application, self-care, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile application
Arm Type
Experimental
Arm Title
Paper booklet
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
ProFibro (Mobile application)
Intervention Description
ProFibro, a mobile Android application in Brazilian Portuguese to promote self-care in patients with fibromyalgia
Intervention Type
Device
Intervention Name(s)
Paper booklet
Intervention Description
A 64-page booklet with content similar to the mobile application
Primary Outcome Measure Information:
Title
Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire
Description
Minimum value: 0. Maximum value: 100. Higher scores mean worse outcome.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Number of Painful Areas Assessed With the Widespread Pain Index
Description
Minimum value: 0. Maximum value: 19.
Time Frame
6 weeks
Title
Pain Assessed With the Visual Analogue Scale
Description
Minimum value: 0. Maximum value: 10. Higher scores mean worse outcome.
Time Frame
6 weeks
Title
Severity of Symptoms Assessed With the Symptom Severity Scale
Description
Minimum value: 0. Maximum value: 12. Higher scores mean worse outcome.
Time Frame
6 weeks
Title
Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised
Description
Minimum value: 15. Maximum value: 75. Higher scores mean better outcome.
Time Frame
6 weeks
Title
Adherence to Mobile Application Assessed by Number of Clicks on the App Functions
Description
Number of clicks on the app functions
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan LK Yuan, MSc
Organizational Affiliation
Rehabilitation Sciences PhD program of the School of Medicine of the University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amelia P Marques, PhD
Organizational Affiliation
Department of Physical Therapy, Speech Therapy and Occupational Therapy of the School of Medicine of the University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Physical Therapy, Speech Therapy and Occupational Therapy of the School of Medicine of the University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05360-160
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23604595
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.
Results Reference
background
PubMed Identifier
19369473
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.
Results Reference
background
PubMed Identifier
10480833
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.
Results Reference
background
PubMed Identifier
15626161
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.
Results Reference
background
PubMed Identifier
23995734
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.
Results Reference
background
PubMed Identifier
19664287
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.
Results Reference
background
PubMed Identifier
16273800
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.
Results Reference
background
PubMed Identifier
18846013
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.
Results Reference
background
PubMed Identifier
20626539
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.
Results Reference
background
PubMed Identifier
24127101
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.
Results Reference
background
PubMed Identifier
20461783
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.
Results Reference
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Links:
URL
https://profibro2018.wordpress.com/
Description
The website briefly explains the stages of the development of ProFibro, the main functions of the application and the test of its efficacy.

Learn more about this trial

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

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