Trial Outcomes & Findings for Evaluating the Effect of a Written Action Plan on Comfort and Understanding of Hidradenitis Suppurativa (NCT NCT04600375)
NCT ID: NCT04600375
Last Updated: 2022-04-13
Results Overview
Number of visits to ER, urgent care, or hospitalizations because of HS
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Through study completion, an average of 1.5 months
Results posted on
2022-04-13
Participant Flow
Participant milestones
| Measure |
Verbal Consultation, Then Written Action Plan
CONTROL GROUP
1. Survey A
2. Routine clinic visit
3. Verbal consultation only
4. Survey B
5. Verbal consultation AND Written Action Plan
6. Survey C
Verbal consultation: Verbal consultation only without written information before receiving written action plan
Written Action Plan: Written handout of treatment plan and disease management strategies
|
Experimental: Written Action Plan
INTERVENTION GROUP
1. Survey A
2. Routine clinic visit
3. Verbal consultation AND Written Action Plan
4. Survey C
Written Action Plan: Written handout of treatment plan and disease management strategies
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
|
Overall Study
COMPLETED
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating the Effect of a Written Action Plan on Comfort and Understanding of Hidradenitis Suppurativa
Baseline characteristics by cohort
| Measure |
Verbal Consultation, Then Written Action Plan
n=12 Participants
CONTROL GROUP
1. Survey A
2. Routine clinic visit
3. Verbal consultation only
4. Survey B
5. Verbal consultation AND Written Action Plan
6. Survey C
Verbal consultation: Verbal consultation only without written information before receiving written action plan
Written Action Plan: Written handout of treatment plan and disease management strategies
|
Experimental: Written Action Plan
n=10 Participants
INTERVENTION GROUP
1. Survey A
2. Routine clinic visit
3. Verbal consultation AND Written Action Plan
4. Survey C
Written Action Plan: Written handout of treatment plan and disease management strategies
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
32.6 years
STANDARD_DEVIATION 8.6 • n=99 Participants
|
34.2 years
STANDARD_DEVIATION 11.9 • n=107 Participants
|
33.3 years
STANDARD_DEVIATION 10.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
10 participants
n=107 Participants
|
22 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1.5 monthsNumber of visits to ER, urgent care, or hospitalizations because of HS
Outcome measures
| Measure |
Verbal Consultation, Then Written Action Plan
n=12 Participants
CONTROL GROUP
1. Survey A
2. Routine clinic visit
3. Verbal consultation only
4. Survey B
5. Verbal consultation AND Written Action Plan
6. Survey C
Verbal consultation: Verbal consultation only without written information before receiving written action plan
Written Action Plan: Written handout of treatment plan and disease management strategies
|
Experimental: Written Action Plan
n=10 Participants
INTERVENTION GROUP
1. Survey A
2. Routine clinic visit
3. Verbal consultation AND Written Action Plan
4. Survey C
Written Action Plan: Written handout of treatment plan and disease management strategies
|
|---|---|---|
|
Visits to High-cost Care Settings [ Time Frame: 1.5 Months ]
|
0 Participants
|
0 Participants
|
Adverse Events
Verbal Consultation, Then Written Action Plan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental: Written Action Plan
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
Dr. Vivian Shi
University of Arkansas for Medical Sciences
Phone: 5015266994
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place