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

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ClinicalTrials.gov Identifier: NCT03004911
Recruitment Status : Completed
First Posted : December 29, 2016
Results First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Fibromyalgia
Interventions Device: ProFibro (Mobile application)
Device: Paper booklet
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mobile Application Paper Booklet
Hide Arm/Group Description The use of ProFibro mobile application for six weeks The use of a 64-page booklet (with content similar to the mobile application) for six weeks
Period Title: Overall Study
Started 20 20
Completed 19 17
Not Completed 1 3
Arm/Group Title Mobile Application Paper Booklet Total
Hide Arm/Group Description The use of ProFibro app for 6 weeks The use of the booklet for 6 weeks Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
43.3  (8.4) 42.1  (11.8) 42.7  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
19
  95.0%
20
 100.0%
39
  97.5%
Male
1
   5.0%
0
   0.0%
1
   2.5%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 20 participants 20 participants 40 participants
20 20 40
Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 20 participants 20 participants 40 participants
62.6  (16.8) 65.4  (18) 64  (17.3)
[1]
Measure Description: Minimum value: 0. Maximum value: 100. Higher scores mean worse outcome.
Number of Painful Areas Assessed With the Widespread Pain Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Number of painful areas
Number Analyzed 20 participants 20 participants 40 participants
13.6  (4) 13.6  (3.7) 13.6  (3.8)
[1]
Measure Description: Minimum value: 0. Maximum value: 19.
Pain Assessed With the Visual Analogue Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 20 participants 20 participants 40 participants
5.9  (2.2) 5.7  (2.2) 5.8  (2.2)
[1]
Measure Description: Minimum value: 0. Maximum value: 10. Higher scores mean worse outcome.
Severity of Symptoms Assessed With the Symptom Severity Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 20 participants 20 participants 40 participants
9.4  (1.5) 9.2  (1.9) 9.3  (1.7)
[1]
Measure Description: Minimum value: 0. Maximum value: 12. Higher scores mean worse outcome.
Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 20 participants 20 participants 40 participants
51.9  (9.7) 53.5  (11) 52.7  (10.3)
[1]
Measure Description: Minimum value: 15. Maximum value: 75. Higher scores mean better outcome.
1.Primary Outcome
Title Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire
Hide Description Minimum value: 0. Maximum value: 100. Higher scores mean worse outcome.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mobile Application Paper Booklet
Hide Arm/Group Description:
The use of ProFibro app for 6 weeks
The use of the booklet for 6 weeks
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
53.7  (17.1) 55.5  (18.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mobile Application, Paper Booklet
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.740
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Number of Painful Areas Assessed With the Widespread Pain Index
Hide Description Minimum value: 0. Maximum value: 19.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mobile Application Paper Booklet
Hide Arm/Group Description:
The use of ProFibro app for 6 weeks
The use of the booklet for 6 weeks
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: number of painful areas
12.5  (4.6) 12.3  (4.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mobile Application, Paper Booklet
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.890
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Pain Assessed With the Visual Analogue Scale
Hide Description Minimum value: 0. Maximum value: 10. Higher scores mean worse outcome.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mobile Application Paper Booklet
Hide Arm/Group Description:
The use of ProFibro app for 6 weeks
The use of the booklet for 6 weeks
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
5.1  (2.6) 5.3  (2.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mobile Application, Paper Booklet
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.747
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Severity of Symptoms Assessed With the Symptom Severity Scale
Hide Description Minimum value: 0. Maximum value: 12. Higher scores mean worse outcome.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mobile Application Paper Booklet
Hide Arm/Group Description:
The use of ProFibro app for 6 weeks
The use of the booklet for 6 weeks
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
7.6  (2.9) 7.6  (2.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mobile Application, Paper Booklet
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised
Hide Description Minimum value: 15. Maximum value: 75. Higher scores mean better outcome.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mobile Application Paper Booklet
Hide Arm/Group Description:
The use of ProFibro app for 6 weeks
The use of the booklet for 6 weeks
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
56.8  (10.2) 54.3  (11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mobile Application, Paper Booklet
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.459
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Adherence to Mobile Application Assessed by Number of Clicks on the App Functions
Hide Description Number of clicks on the app functions
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mobile Application
Hide Arm/Group Description:
The use of ProFibro app for 6 weeks
Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: Clicks on app functions
106
(12 to 237)
Time Frame 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mobile Application Paper Booklet
Hide Arm/Group Description The use of ProFibro app for 6 weeks The use of the booklet for 6 weeks
All-Cause Mortality
Mobile Application Paper Booklet
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Mobile Application Paper Booklet
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mobile Application Paper Booklet
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Amélia Pasqual Marques
Organization: School of Medicine at the University of Sao Paulo
Phone: +55 11 3091 7451
Publications:
Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03004911     History of Changes
Other Study ID Numbers: 274/14
First Submitted: December 21, 2016
First Posted: December 29, 2016
Results First Submitted: December 4, 2018
Results First Posted: June 17, 2019
Last Update Posted: June 17, 2019