Fibromyalgia
Conditions
Keywords
fibromyalgia, mobile application, self-care, quality of life
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.
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
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 59 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire | 6 weeks | Minimum value: 0. Maximum value: 100. Higher scores mean worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Painful Areas Assessed With the Widespread Pain Index | 6 weeks | Minimum value: 0. Maximum value: 19. |
| Pain Assessed With the Visual Analogue Scale | 6 weeks | Minimum value: 0. Maximum value: 10. Higher scores mean worse outcome. |
| Severity of Symptoms Assessed With the Symptom Severity Scale | 6 weeks | Minimum value: 0. Maximum value: 12. Higher scores mean worse outcome. |
| Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised | 6 weeks | Minimum value: 15. Maximum value: 75. Higher scores mean better outcome. |
| Adherence to Mobile Application Assessed by Number of Clicks on the App Functions | 6 weeks | Number of clicks on the app functions |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mobile Application The use of ProFibro app for 6 weeks | 20 |
| Paper Booklet The use of the booklet for 6 weeks | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Mobile Application | Paper Booklet | Total |
|---|---|---|---|
| Age, Continuous | 43.3 years STANDARD_DEVIATION 8.4 | 42.1 years STANDARD_DEVIATION 11.8 | 42.7 years STANDARD_DEVIATION 10.1 |
| Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire | 62.6 score on a scale STANDARD_DEVIATION 16.8 | 65.4 score on a scale STANDARD_DEVIATION 18 | 64 score on a scale STANDARD_DEVIATION 17.3 |
| Number of Painful Areas Assessed With the Widespread Pain Index | 13.6 number of painful areas STANDARD_DEVIATION 4 | 13.6 number of painful areas STANDARD_DEVIATION 3.7 | 13.6 number of painful areas STANDARD_DEVIATION 3.8 |
| Pain Assessed With the Visual Analogue Scale | 5.9 score on a scale STANDARD_DEVIATION 2.2 | 5.7 score on a scale STANDARD_DEVIATION 2.2 | 5.8 score on a scale STANDARD_DEVIATION 2.2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Brazil | 20 participants | 20 participants | 40 participants |
| Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised | 51.9 score on a scale STANDARD_DEVIATION 9.7 | 53.5 score on a scale STANDARD_DEVIATION 11 | 52.7 score on a scale STANDARD_DEVIATION 10.3 |
| Severity of Symptoms Assessed With the Symptom Severity Scale | 9.4 score on a scale STANDARD_DEVIATION 1.5 | 9.2 score on a scale STANDARD_DEVIATION 1.9 | 9.3 score on a scale STANDARD_DEVIATION 1.7 |
| Sex: Female, Male Female | 19 Participants | 20 Participants | 39 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Application | Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire | 53.7 score on a scale | Standard Deviation 17.1 |
| Paper Booklet | Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire | 55.5 score on a scale | Standard Deviation 18.2 |
p-value: 0.74t-test, 2 sided
Secondary
Adherence to Mobile Application Assessed by Number of Clicks on the App Functions
Number of clicks on the app functions
Time frame: 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mobile Application | Adherence to Mobile Application Assessed by Number of Clicks on the App Functions | 106 Clicks on app functions |
Secondary
Number of Painful Areas Assessed With the Widespread Pain Index
Minimum value: 0. Maximum value: 19.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Application | Number of Painful Areas Assessed With the Widespread Pain Index | 12.5 number of painful areas | Standard Deviation 4.6 |
| Paper Booklet | Number of Painful Areas Assessed With the Widespread Pain Index | 12.3 number of painful areas | Standard Deviation 4.5 |
p-value: 0.89t-test, 2 sided
Secondary
Pain Assessed With the Visual Analogue Scale
Minimum value: 0. Maximum value: 10. Higher scores mean worse outcome.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Application | Pain Assessed With the Visual Analogue Scale | 5.1 score on a scale | Standard Deviation 2.6 |
| Paper Booklet | Pain Assessed With the Visual Analogue Scale | 5.3 score on a scale | Standard Deviation 2.3 |
p-value: 0.747t-test, 2 sided
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Application | Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised | 56.8 score on a scale | Standard Deviation 10.2 |
| Paper Booklet | Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised | 54.3 score on a scale | Standard Deviation 11 |
p-value: 0.459t-test, 2 sided
Secondary
Severity of Symptoms Assessed With the Symptom Severity Scale
Minimum value: 0. Maximum value: 12. Higher scores mean worse outcome.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Application | Severity of Symptoms Assessed With the Symptom Severity Scale | 7.6 score on a scale | Standard Deviation 2.9 |
| Paper Booklet | Severity of Symptoms Assessed With the Symptom Severity Scale | 7.6 score on a scale | Standard Deviation 2.4 |
p-value: 1t-test, 2 sided