FibromyalgiaNCT03004911

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

A study testing ProFibro (Mobile application) and Paper booklet in people with Fibromyalgia, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 19 to 59 years
Conditions the study is for: Fibromyalgia
What is being tested?: ProFibro (Mobile application) and Paper booklet
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteBrazil
Study dates: 14 Feb 2017to 12 Dec 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 59 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Department of Physical Therapy, Speech Therapy and Occupational Therapy of the School of Medicine of the University of Sao Paulo
São Paulo, 05360-160

Other trials in Brazil

About this study

Conditions: Fibromyalgia
Being tested: ProFibro (Mobile application), Paper booklet
Keywords: fibromyalgia, mobile application, self-care, quality of life
Medical subject headings: Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03004911
Study group	Role	What they receive
Mobile application	Experimental	Not described Receives: Device: ProFibro (Mobile application)
Paper booklet	Active comparator	Not described Receives: Device: Paper booklet

What is being measured

The primary outcome is the main question the study is designed to answer.

Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire
Minimum value: 0. Maximum value: 100. Higher scores mean worse outcome.
Measured: 6 weeks

Secondary outcomes (5)

Number of Painful Areas Assessed With the Widespread Pain Index
Minimum value: 0. Maximum value: 19.
Measured: 6 weeks
Pain Assessed With the Visual Analogue Scale
Minimum value: 0. Maximum value: 10. Higher scores mean worse outcome.
Measured: 6 weeks
Severity of Symptoms Assessed With the Symptom Severity Scale
Minimum value: 0. Maximum value: 12. Higher scores mean worse outcome.
Measured: 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.
Measured: 6 weeks
Adherence to Mobile Application Assessed by Number of Clicks on the App Functions
Number of clicks on the app functions
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 201712 Dec 2017

First posted29 Dec 2016 (estimated)
Study start14 Feb 2017
Primary completion12 Dec 2017
Study completion12 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (11)Papers the sponsor has linked to this study.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03004911
Sponsor's protocol ID: 274/14
Status last verified: Dec 2016
First submitted: 21 Dec 2016
Last updated: 17 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development of a Mobile Application to Promote Self-care in Patients With Fibromyalgia
ClinicalTrials.gov ID: NCT03004911
Acronym / sponsor ID: 274/14
Conditions: Fibromyalgia
Keywords: fibromyalgia, mobile application, self-care, quality of life
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: University of Sao Paulo General HospitalUniversity, hospital or other
Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
Study start: 14 Feb 2017 (actual)
Primary completion: 12 Dec 2017 (actual)
Study completion: 12 Dec 2017 (actual)
First posted: 29 Dec 2016 (estimated)
Results: Posted 17 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Mobile application	Experimental	Device: ProFibro (Mobile application)
Paper booklet	Active comparator	Device: Paper booklet

Who may qualify

Ages: 19 to 59 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

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

Primary outcome

Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire
Time frame: 6 weeks
Minimum value: 0. Maximum value: 100. Higher scores mean worse outcome.

5 secondary outcomes

Number of Painful Areas Assessed With the Widespread Pain Index
Time frame: 6 weeks
Pain Assessed With the Visual Analogue Scale
Time frame: 6 weeks
Severity of Symptoms Assessed With the Symptom Severity Scale
Time frame: 6 weeks
Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised
Time frame: 6 weeks
Adherence to Mobile Application Assessed by Number of Clicks on the App Functions
Time frame: 6 weeks

Results and safety

Results posted to the registry on 17 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mobile Application	20	19
Paper Booklet	20	17

Primary outcome: Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire

Time frame: 6 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Mobile Application n = 20	Paper Booklet n = 20
Value	53.7 (17.1)	55.5 (18.2)

Mobile Application vs Paper Booklet: p = 0.740, t-test, 2 sided

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mobile Application	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Paper Booklet	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23604595Paiva 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.
Background: PubMed 19369473Bennett 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.
Background: PubMed 10480833Altman DG, Bland JM. How to randomise. BMJ. 1999 Sep 11;319(7211):703-4. doi: 10.1136/bmj.319.7211.703. No abstract available.
Background: PubMed 15626161Henriksson 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.
Background: PubMed 23995734Nam 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.
Background: PubMed 19664287Bennett 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.
Background: PubMed 16273800Bennett 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.
Background: PubMed 18846013Marques 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.
Background: PubMed 20626539Sousa 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.
Background: PubMed 24127101Damasio 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.
Background: PubMed 20461783Wolfe 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.
The website briefly explains the stages of the development of ProFibro, the main functions of the application and the test of its efficacy.Link provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Fibromyalgia

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
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Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ProFibro (Mobile application) and Paper booklet in people with Fibromyalgia, run by University of Sao Paulo General Hospital at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03004911, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2019.