Development of a Mobile Application to Promote Self-care in Patients With Fibromyalgia
Phase: NA
Conditions: Fibromyalgia
Sponsor: University of Sao Paulo General Hospital

University of Sao Paulo 
 
 
 
 
 
 
 
DEVELOPMENT OF A MOBILE APPLICATION TO PROMOTE SELF-CARE IN PATIENTS 
WITH FIBROMYALGIA 
 
 
 
Susan Lee King Yuan 
Amélia Pasqual Marques 
 
 
 
 
 
The study protocol was registered at ClinicalTrials.gov. 
 
Registration No.: NCT0300491 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sao Paulo 
July 14th 2014 

Objectives 
 
The purpose of this work was to develop a mobile application software for the promotion of 
self-care and assess the effectiveness of its use during six weeks on health-related quality of life, 
symptoms and self-care agency of patients with FMS, and to compare the results to the use of a paper 
book of similar content. Secondarily, patients’ adherence to ProFibro app was evaluated. 
 
Methods 
 
A randomized, single-blind, controlled trial was conducted in the Physical Therapy Clinical 
Research and Electromyography Laboratory at the Physical Therapy, Speech Therapy and 
Occupational Therapy Department of the School of Medicine of the University of Sao Paulo (USP), 
in the city of Sao Paulo, Brazil. The project was approved by the Research Ethics Committee of the 
School of Medicine, University of Sao Paulo (No. 274/14). 
 
Participants (eligibility criteria) 
 
Volunteers were identified using the USP Newspaper and related social media. After 
answering a screening questionnaire sent by email, potential participants were invited to a face-to- 
face assessment to confirm eligibility. All participants signed a written informed consent prior to 
entering the study. 
 
The study included adults and middle-aged individuals (19-59 years) diagnosed with FMS, 
according to the 2010 American College of Rheumatology (ACR) diagnostic criteria1, who were 
smartphone users and completed elementary education. Exclusion criteria were: individuals 
undergoing physical therapy or treated in the last three months; diagnosis of other conditions causing 
chronic pain (neuropathies, rheumatoid arthritis, osteoarthritis, spinal stenosis or cancer); severe 
mental disorders (schizophrenia, psychosis, bipolar affective disorder, severe depression); hearing or 
visual impairment. 
 
Sample Size 
 
The sample size was calculated to detect the minimal clinically important difference (MCID) 
of 14% between two groups in health-related quality of life, measured by the FIQR, with a standard 

deviation of 24.3.2, 3 Calculations indicated that a sample size of 30 participants would provide a 
power of 80% at a level of significance of 5%. Five participants were added to each group to 
compensate for possible dropouts, resulting in a total of 40 participants. 
 
Randomization 
 
Participants were randomly allocated into Experimental and Control Groups. A physical 
therapist who was not involved in the trial concealed a computer-generated random sequence in 
sequentially numbered, opaque, sealed envelopes. 
 
Outcomes 
 
An outcome assessor blinded to the interventions enrolled participants in the trial and 
evaluated them at baseline and after six weeks of intervention. 
 
At baseline, the following demographic and clinical data were collected: age, sex, marital 
status, level of education, family income, duration of the syndrome and use of medication. 
 
The primary outcome was health-related quality of life measured by the Brazilian Portuguese 
version of the FIQR.3, 4 The FIQR has 21 questions based on an 11-point numeric rating scale of 0 to 
10, with 10 being 'worst'. All questions are framed in the context of the past seven days. The FIQR is 
divided into three domains: (a) Function (contains nine questions), Overall Impact (contains two 
questions), and (c) Symptoms (contains ten questions regarding pain, stiffness, lack of restorative 
sleep, poor energy, anxiety, depression, tenderness, memory, balance and environmental sensitivity). 
The Function score is the sum of the nine questions divided by 3 (range 0 to 30), the Overall Impact 
score is the sum of two questions (range 0 to 20), and the Symptoms score is the sum of the ten 
questions divided by 2 (range 0 to 50). The total FIQR is the sum of the three domain scores (range 0 
to 100). 
 
Secondary outcomes were: pain measured by the Widespread Pain Index (WPI)1 and the 
Visual Analog Scale (VAS)5; severity of symptoms measured by the Symptom Severity (SS) Scale1; 
agency of self-care measured by the Brazilian Portuguese version of the Appraisal of Self-Care 
Agency Scale – Revised (ASAS-R)6, 7. 
The WPI is one of the diagnostic variables of the 2010 ACR diagnostic criteria for FMS. It is 
a measure of the number of painful body regions (range 0 to 19) in the context of the past week. 
 
The VAS for pain was used to measure the pain intensity (range 0 to 10) at the moment of the 
examination. It is a continuous scale comprised of a 10-cm horizontal line, anchored by two verbal 
descriptors: no pain (score of 0) and worst imaginable pain (score of 10). 
 
The SS Scale is another diagnostic variable of the 2010 ACR diagnostic criteria. It is a 4- 
component scale (range 0 to 12) composed of assessor-rated cognitive problems, unrefreshed sleep, 
fatigue and somatic symptom count. The timeframe for the assessment of the SS Scale is one week. 

The ASAS-R is a multidimensional measure that evaluates the level of self-care agency 
regarding having, developing and lacking the power for self-care (range 15 to 75). It comprises 15 
items responded in a five-point Likert scale ranging from 1 (totally disagree) to 5 (totally agree). 
 
ProFibro app was programmed to register the date and time of each access to the app 
functions. Patients’ adherence to the use of ProFibro app was assessed according to the number of 
accesses to the app functions after six weeks. 
 
Interventions 
 
A physical therapist researcher who was not involved in the outcome assessment opened the 
sealed envelopes and assigned participants to each group. 
 
At their first individual session, the researcher gave the participants of the Experimental 
Group a smartphone with the ProFibro app installed, and the participants of the Control Group a 
paper book of similar content to that of the mobile app. The book was made after the development of 
the mobile app was completed. 
 
Both groups received a 20-min introductory tutorial leading the participants through the main 
functions of the mobile app or book chapters. For further instructions, the information icon of the app 
functions and tutorial video in the menu were presented to the participants of the Experimental 
Group. Finally, the participants were instructed to explore and use the tools for six weeks with a  
view to self-care. 
 
Statistical methods 
 
Primary and secondary outcomes were compared to baseline in each group and between 
groups. Change scores (the difference between the final and the baseline score) were used for 
comparison between groups. Analysis was performed on an intention-to-treat basis, with data carried 
forward from the baseline assessment in case of dropouts. Kolmogorov-Smirnov and Levene tests 
were used to verify normality and equality of variance of the data, respectively. Independent t tests 
were used with variables that were normally distributed, and Mann-Whitney rank sum tests were 
used with variables that were not normally distributed. A p-value <0.05 was considered statistically 
significant. These statistical tests were performed using software SigmaStat 3.5 (Systat Software,  
Inc, Erkrath, Germany). 
 
In the analysis of clinical important changes, participants were classified as respondents if 
they scored higher than the MCID for an outcome, and non-respondents otherwise. The MCID for 
the FIQR total score was considered a change score of 8.1, and for VAS pain a change score of 2.2, 8, 
9 For the other variables, no MCID was yet identified, and a change score of 15% was used.10 
Funding 
 
This work was supported by the Sao Paulo Research Foundation (FAPESP No. 2014/17547-5). 

1. 
Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, et al. 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. 
2. 
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. 
3. 
Paiva ES, Heymann RE, Rezende MC, Helfenstein M, Jr., Martinez JE, Provenza JR, et al. A 
Brazilian Portuguese version of the Revised Fibromyalgia Impact Questionnaire (FIQR): a validation 
study. Clin Rheumatol. 2013 Aug;32(8):1199-206. 
4. 
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. 
5. 
Marques AP, Assumpcao A, Matsutani LA, Pereira CAB, Lage L. Pain in Fibromyalgia and 
Discriminative Power of the Instruments: Visual Analog Scale, Dolorimetry and the Mcgill Pain 
Questionnaire. Acta Reumatol Port. 2008 Jul-Sep;33(3):345-51. 
6. 
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. 
7. 
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. 
8. 
Farrar JT, Young JP, Jr., LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes 
in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 
Nov;94(2):149-58. 
9. 
Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important 
changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain. 
2004 Aug;8(4):283-91. 
10. 
Philadelphia Panel evidence-based clinical practice guidelines on selected rehabilitation 
interventions: overview and methodology. Phys Ther. 2001 Oct;81(10):1629-40.