Trial Outcomes & Findings for Gout in the ED and Improving Research Participation (NCT NCT04075903)
NCT ID: NCT04075903
Last Updated: 2025-12-03
Results Overview
Proportion of participants who attend a primary care or specialist visits for gout treatment
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
3 months
Results posted on
2025-12-03
Participant Flow
Participant milestones
| Measure |
Intervention
Storytelling and Navigation A health literacy-appropriate and culturally-adapted intervention delivered on a tablet computer containing "storytelling" to improve patient gout knowledge and approaches to prevent flares, destigmatize gout, and enhance readiness to adopt available long-term treatments for gout including medications, diet, and exercise, along with post-emergency department visit patient navigation to promote outpatient follow-up
|
Control
Usual Care
|
|---|---|---|
|
Overall Study
STARTED
|
135
|
65
|
|
Overall Study
COMPLETED
|
135
|
65
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gout in the ED and Improving Research Participation
Baseline characteristics by cohort
| Measure |
Intervention
n=135 Participants
Storytelling and Navigation A health literacy-appropriate and culturally-adapted intervention delivered on a tablet computer containing "storytelling" to improve patient gout knowledge and approaches to prevent flares, destigmatize gout, and enhance readiness to adopt available long-term treatments for gout including medications, diet, and exercise, along with post-emergency department visit patient navigation to promote outpatient follow-up.
|
Control
n=65 Participants
Usual Care
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 13.6 • n=3 Participants
|
58.9 years
STANDARD_DEVIATION 12.4 • n=3 Participants
|
58 years
STANDARD_DEVIATION 13.1 • n=6 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=3 Participants
|
15 Participants
n=3 Participants
|
49 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=3 Participants
|
50 Participants
n=3 Participants
|
151 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
92 Participants
n=3 Participants
|
45 Participants
n=3 Participants
|
137 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
35 Participants
n=3 Participants
|
16 Participants
n=3 Participants
|
51 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Asian, Hispanic or Latino, Unknown/Other
|
8 Participants
n=3 Participants
|
4 Participants
n=3 Participants
|
12 Participants
n=6 Participants
|
|
Education Level
High School Graduate or Less
|
65 Participants
n=3 Participants
|
30 Participants
n=3 Participants
|
95 Participants
n=6 Participants
|
|
Education Level
Vocational Training or Some College
|
44 Participants
n=3 Participants
|
23 Participants
n=3 Participants
|
67 Participants
n=6 Participants
|
|
Education Level
4-year Degree or More Completed
|
23 Participants
n=3 Participants
|
12 Participants
n=3 Participants
|
35 Participants
n=6 Participants
|
|
Employment Status
Full-Time Work
|
61 Participants
n=3 Participants
|
19 Participants
n=3 Participants
|
80 Participants
n=6 Participants
|
|
Employment Status
Part-Time Work or Not Seeking Work
|
37 Participants
n=3 Participants
|
22 Participants
n=3 Participants
|
59 Participants
n=6 Participants
|
|
Employment Status
Unemployed
|
25 Participants
n=3 Participants
|
16 Participants
n=3 Participants
|
41 Participants
n=6 Participants
|
|
Employment Status
Other or Choose not to Answer
|
8 Participants
n=3 Participants
|
8 Participants
n=3 Participants
|
16 Participants
n=6 Participants
|
|
Yearly Income
Less than $30,000
|
42 Participants
n=3 Participants
|
20 Participants
n=3 Participants
|
62 Participants
n=6 Participants
|
|
Yearly Income
$30,000 to less than $60,000
|
13 Participants
n=3 Participants
|
13 Participants
n=3 Participants
|
26 Participants
n=6 Participants
|
|
Yearly Income
$60,000 to less than $100,000
|
14 Participants
n=3 Participants
|
8 Participants
n=3 Participants
|
22 Participants
n=6 Participants
|
|
Yearly Income
Greater than $100,000
|
11 Participants
n=3 Participants
|
4 Participants
n=3 Participants
|
15 Participants
n=6 Participants
|
|
Yearly Income
Prefer not to answer
|
44 Participants
n=3 Participants
|
18 Participants
n=3 Participants
|
62 Participants
n=6 Participants
|
|
Smoking Status
Currently Smoking Everyday
|
17 Participants
n=3 Participants
|
9 Participants
n=3 Participants
|
26 Participants
n=6 Participants
|
|
Smoking Status
Currently Smoking Some Days
|
18 Participants
n=3 Participants
|
4 Participants
n=3 Participants
|
22 Participants
n=6 Participants
|
|
Smoking Status
Not Smoking at All
|
97 Participants
n=3 Participants
|
50 Participants
n=3 Participants
|
147 Participants
n=6 Participants
|
|
Alcohol Use
2 or more times per week
|
24 Participants
n=3 Participants
|
10 Participants
n=3 Participants
|
34 Participants
n=6 Participants
|
|
Alcohol Use
2-4 times per month
|
53 Participants
n=3 Participants
|
22 Participants
n=3 Participants
|
75 Participants
n=6 Participants
|
|
Alcohol Use
Never
|
54 Participants
n=3 Participants
|
33 Participants
n=3 Participants
|
87 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 3 monthsProportion of participants who attend a primary care or specialist visits for gout treatment
Outcome measures
| Measure |
Intervention
n=135 Participants
Storytelling and Navigation A health literacy-appropriate and culturally-adapted intervention delivered on a tablet computer containing "storytelling" to improve patient gout knowledge and approaches to prevent flares, destigmatize gout, and enhance readiness to adopt available long-term treatments for gout including medications, diet, and exercise, along with post-emergency department visit patient navigation to promote outpatient follow-up
|
Control
n=65 Participants
Usual Care
|
|---|---|---|
|
Outpatient Primary Care or Specialist Visits for Gout Treatment
Presence of Gout Follow-Up
|
64 Participants
|
35 Participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Lesley Jackson, MD, MSPH
University of Alabama at Birmingham Division of Clinical Immunology and Rheumatology
Phone: 205-934-1779
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place