Trial Outcomes & Findings for Development of a Mobile Application to Promote Self-care in Patients With Fibromyalgia (NCT NCT03004911)
NCT ID: NCT03004911
Last Updated: 2019-06-17
Results Overview
Minimum value: 0. Maximum value: 100. Higher scores mean worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
6 weeks
Results posted on
2019-06-17
Participant Flow
Participant milestones
| Measure |
Mobile Application
The use of ProFibro mobile application for six weeks
|
Paper Booklet
The use of a 64-page booklet (with content similar to the mobile application) for six weeks
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Mobile Application
n=20 Participants
The use of ProFibro app for 6 weeks
|
Paper Booklet
n=20 Participants
The use of the booklet for 6 weeks
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 8.4 • n=20 Participants
|
42.1 years
STANDARD_DEVIATION 11.8 • n=20 Participants
|
42.7 years
STANDARD_DEVIATION 10.1 • n=40 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
39 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Brazil
|
20 participants
n=20 Participants
|
20 participants
n=20 Participants
|
40 participants
n=40 Participants
|
|
Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire
|
62.6 score on a scale
STANDARD_DEVIATION 16.8 • n=20 Participants
|
65.4 score on a scale
STANDARD_DEVIATION 18 • n=20 Participants
|
64 score on a scale
STANDARD_DEVIATION 17.3 • n=40 Participants
|
|
Number of Painful Areas Assessed With the Widespread Pain Index
|
13.6 number of painful areas
STANDARD_DEVIATION 4 • n=20 Participants
|
13.6 number of painful areas
STANDARD_DEVIATION 3.7 • n=20 Participants
|
13.6 number of painful areas
STANDARD_DEVIATION 3.8 • n=40 Participants
|
|
Pain Assessed With the Visual Analogue Scale
|
5.9 score on a scale
STANDARD_DEVIATION 2.2 • n=20 Participants
|
5.7 score on a scale
STANDARD_DEVIATION 2.2 • n=20 Participants
|
5.8 score on a scale
STANDARD_DEVIATION 2.2 • n=40 Participants
|
|
Severity of Symptoms Assessed With the Symptom Severity Scale
|
9.4 score on a scale
STANDARD_DEVIATION 1.5 • n=20 Participants
|
9.2 score on a scale
STANDARD_DEVIATION 1.9 • n=20 Participants
|
9.3 score on a scale
STANDARD_DEVIATION 1.7 • n=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 • n=20 Participants
|
53.5 score on a scale
STANDARD_DEVIATION 11 • n=20 Participants
|
52.7 score on a scale
STANDARD_DEVIATION 10.3 • n=40 Participants
|
PRIMARY outcome
Timeframe: 6 weeksMinimum value: 0. Maximum value: 100. Higher scores mean worse outcome.
Outcome measures
| Measure |
Mobile Application
n=20 Participants
The use of ProFibro app for 6 weeks
|
Paper Booklet
n=20 Participants
The use of the booklet for 6 weeks
|
|---|---|---|
|
Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire
|
53.7 score on a scale
Standard Deviation 17.1
|
55.5 score on a scale
Standard Deviation 18.2
|
SECONDARY outcome
Timeframe: 6 weeksMinimum value: 0. Maximum value: 19.
Outcome measures
| Measure |
Mobile Application
n=20 Participants
The use of ProFibro app for 6 weeks
|
Paper Booklet
n=20 Participants
The use of the booklet for 6 weeks
|
|---|---|---|
|
Number of Painful Areas Assessed With the Widespread Pain Index
|
12.5 number of painful areas
Standard Deviation 4.6
|
12.3 number of painful areas
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: 6 weeksMinimum value: 0. Maximum value: 10. Higher scores mean worse outcome.
Outcome measures
| Measure |
Mobile Application
n=20 Participants
The use of ProFibro app for 6 weeks
|
Paper Booklet
n=20 Participants
The use of the booklet for 6 weeks
|
|---|---|---|
|
Pain Assessed With the Visual Analogue Scale
|
5.1 score on a scale
Standard Deviation 2.6
|
5.3 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 6 weeksMinimum value: 0. Maximum value: 12. Higher scores mean worse outcome.
Outcome measures
| Measure |
Mobile Application
n=20 Participants
The use of ProFibro app for 6 weeks
|
Paper Booklet
n=20 Participants
The use of the booklet for 6 weeks
|
|---|---|---|
|
Severity of Symptoms Assessed With the Symptom Severity Scale
|
7.6 score on a scale
Standard Deviation 2.9
|
7.6 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 6 weeksMinimum value: 15. Maximum value: 75. Higher scores mean better outcome.
Outcome measures
| Measure |
Mobile Application
n=20 Participants
The use of ProFibro app for 6 weeks
|
Paper Booklet
n=20 Participants
The use of the booklet for 6 weeks
|
|---|---|---|
|
Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised
|
56.8 score on a scale
Standard Deviation 10.2
|
54.3 score on a scale
Standard Deviation 11
|
SECONDARY outcome
Timeframe: 6 weeksNumber of clicks on the app functions
Outcome measures
| Measure |
Mobile Application
n=20 Participants
The use of ProFibro app for 6 weeks
|
Paper Booklet
The use of the booklet for 6 weeks
|
|---|---|---|
|
Adherence to Mobile Application Assessed by Number of Clicks on the App Functions
|
106 Clicks on app functions
Interval 12.0 to 237.0
|
—
|
Adverse Events
Mobile Application
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Paper Booklet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Amélia Pasqual Marques
School of Medicine at the University of Sao Paulo
Phone: +55 11 3091 7451
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place