CClinicalTrials.gg
Sign In
CompletedNCT03004911Updated Jun 17, 2019Results posted

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

An interventional study of ProFibro (Mobile application) and Paper booklet in Fibromyalgia, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to participants aged 19 Years to 59 Years. Per ClinicalTrials.gov, last updated 2019-06-17.

Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
19 Years to 59 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Fibromyalgia

Keywords

  • fibromyalgia
  • mobile application
  • self-care
  • quality of life
03

In context

Fibromyalgia

1,335 studies on the registry are indexed under Fibromyalgia; 265 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 1,034 interventional studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Mobile application

    Device: ProFibro (Mobile application)

  • Active comparator
    Paper booklet

    Device: Paper booklet

Interventions

  • DeviceProFibro (Mobile application)

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

  • DevicePaper booklet

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

06

What researchers measure

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.

    Time frame: 6 weeks

Secondary outcomes

  1. Number of Painful Areas Assessed With the Widespread Pain Index

    Minimum value: 0. Maximum value: 19.

    Time frame: 6 weeks

  2. Pain Assessed With the Visual Analogue Scale

    Minimum value: 0. Maximum value: 10. Higher scores mean worse outcome.

    Time frame: 6 weeks

  3. Severity of Symptoms Assessed With the Symptom Severity Scale

    Minimum value: 0. Maximum value: 12. Higher scores mean worse outcome.

    Time frame: 6 weeks

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

    Minimum value: 15. Maximum value: 75. Higher scores mean better outcome.

    Time frame: 6 weeks

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

    Number of clicks on the app functions

    Time frame: 6 weeks

07

Results

Posted Jun 17, 2019

Participant flow

Participant flow — Overall Study
MilestoneMobile ApplicationPaper Booklet
Started2020
Completed1917
Not completed13

Outcome measures

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

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

Time frame:
6 weeks
Reported as:
Mean · score on a scale
Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire
score on a scaleMobile ApplicationPaper Booklet
Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire53.7 ± 17.155.5 ± 18.2
Statistical analysis
  • Mobile Application vs Paper Booklet · t-test, 2 sided · p = 0.740
SecondaryNumber of Painful Areas Assessed With the Widespread Pain Index

Minimum value: 0. Maximum value: 19.

Time frame:
6 weeks
Reported as:
Mean · number of painful areas
Number of Painful Areas Assessed With the Widespread Pain Index
number of painful areasMobile ApplicationPaper Booklet
Number of Painful Areas Assessed With the Widespread Pain Index12.5 ± 4.612.3 ± 4.5
Statistical analysis
  • Mobile Application vs Paper Booklet · t-test, 2 sided · p = 0.890
SecondaryPain Assessed With the Visual Analogue Scale

Minimum value: 0. Maximum value: 10. Higher scores mean worse outcome.

Time frame:
6 weeks
Reported as:
Mean · score on a scale
Pain Assessed With the Visual Analogue Scale
score on a scaleMobile ApplicationPaper Booklet
Pain Assessed With the Visual Analogue Scale5.1 ± 2.65.3 ± 2.3
Statistical analysis
  • Mobile Application vs Paper Booklet · t-test, 2 sided · p = 0.747
SecondarySeverity of Symptoms Assessed With the Symptom Severity Scale

Minimum value: 0. Maximum value: 12. Higher scores mean worse outcome.

Time frame:
6 weeks
Reported as:
Mean · score on a scale
Severity of Symptoms Assessed With the Symptom Severity Scale
score on a scaleMobile ApplicationPaper Booklet
Severity of Symptoms Assessed With the Symptom Severity Scale7.6 ± 2.97.6 ± 2.4
Statistical analysis
  • Mobile Application vs Paper Booklet · t-test, 2 sided · p = 1.000
SecondarySelf-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised

Minimum value: 15. Maximum value: 75. Higher scores mean better outcome.

Time frame:
6 weeks
Reported as:
Mean · score on a scale
Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised
score on a scaleMobile ApplicationPaper Booklet
Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised56.8 ± 10.254.3 ± 11
Statistical analysis
  • Mobile Application vs Paper Booklet · t-test, 2 sided · p = 0.459
SecondaryAdherence to Mobile Application Assessed by Number of Clicks on the App Functions

Number of clicks on the app functions

Time frame:
6 weeks
Reported as:
Median · Clicks on app functions
Adherence to Mobile Application Assessed by Number of Clicks on the App Functions
Clicks on app functionsMobile Application
Adherence to Mobile Application Assessed by Number of Clicks on the App Functions106 (12 to 237)

Adverse events

Collected over 6 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Mobile Application0/20 (0%)0/20 (0%)0/20 (0%)
Paper Booklet0/20 (0%)0/20 (0%)0/20 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Mobile ApplicationPaper BookletTotal
Mean43.3 ± 8.442.1 ± 11.842.7 ± 10.1
Sex: Female, Male
Sex: Female, Male(Participants)Mobile ApplicationPaper BookletTotal
Female192039
Male101
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Mobile ApplicationPaper BookletTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Mobile ApplicationPaper BookletTotal
Brazil202040
Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire
Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire(score on a scale)Mobile ApplicationPaper BookletTotal
Mean62.6 ± 16.865.4 ± 1864 ± 17.3
Number of Painful Areas Assessed With the Widespread Pain Index
Number of Painful Areas Assessed With the Widespread Pain Index(number of painful areas)Mobile ApplicationPaper BookletTotal
Mean13.6 ± 413.6 ± 3.713.6 ± 3.8
Pain Assessed With the Visual Analogue Scale
Pain Assessed With the Visual Analogue Scale(score on a scale)Mobile ApplicationPaper BookletTotal
Mean5.9 ± 2.25.7 ± 2.25.8 ± 2.2
Severity of Symptoms Assessed With the Symptom Severity Scale
Severity of Symptoms Assessed With the Symptom Severity Scale(score on a scale)Mobile ApplicationPaper BookletTotal
Mean9.4 ± 1.59.2 ± 1.99.3 ± 1.7

1 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Department of Physical Therapy, Speech Therapy and Occupational Therapy of the School of Medicine of the University of Sao Paulo
    Sao Paulo, 05360-160, Brazil
09

References and documents

Publications

  • 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. PubMed 23604595 ↗
  • 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. PubMed 19369473 ↗
  • 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. PubMed 10480833 ↗
  • 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. PubMed 15626161 ↗
  • 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. PubMed 23995734 ↗
  • 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. PubMed 19664287 ↗
  • 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. PubMed 16273800 ↗
  • 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. PubMed 18846013 ↗
  • 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. PubMed 20626539 ↗
  • 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. PubMed 24127101 ↗
  • 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. PubMed 20461783 ↗

Study documents

  • Protocol and statistical analysis plan · Jul 14, 2014

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03004911
Lead sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
Responsible party
Sponsor
First posted
Dec 29, 2016
Start date
Feb 14, 2017
Primary completion
Dec 12, 2017
Completion
Dec 12, 2017
Results posted
Jun 17, 2019
Last update
Jun 17, 2019

Study contacts

Susan LK Yuan, MSc
principal investigator · Rehabilitation Sciences PhD program of the School of Medicine of the University of Sao Paulo
Amelia P Marques, PhD
study chair · Department of Physical Therapy, Speech Therapy and Occupational Therapy of the School of Medicine of the University of Sao Paulo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Fibromyalgia→

Other studies from this sponsor

University of Sao Paulo General Hospital

Start the discussion