Trial Outcomes & Findings for Virtual Gout Clinic (NCT NCT02790463)
NCT ID: NCT02790463
Last Updated: 2019-11-12
Results Overview
Adherence to prescribed medication
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1463 participants
Primary outcome timeframe
12 months
Results posted on
2019-11-12
Participant Flow
Participant milestones
| Measure |
Usual Care
Participants recruited in this arm will receive their usual care for gout as they normally would
|
Intervention
Participants recruited to this arm will receive their usual gout care + pharmacist-led intervention
Pharmacist-Led Intervention: Pharmacists will conduct outreach primarily via an automated telephone interactive voice recognition system and direct (telephone) contact
|
|---|---|---|
|
Overall Study
STARTED
|
782
|
681
|
|
Overall Study
COMPLETED
|
782
|
372
|
|
Overall Study
NOT COMPLETED
|
0
|
309
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Virtual Gout Clinic
Baseline characteristics by cohort
| Measure |
Usual Care
n=782 Participants
Participants recruited in this arm will receive their usual care for gout as they normally would
|
Intervention
n=681 Participants
Participants recruited to this arm will receive their usual gout care + pharmacist-led intervention
Pharmacist-Led Intervention: Pharmacists will conduct outreach primarily via an automated telephone interactive voice recognition system and direct (telephone) contact
|
Total
n=1463 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.0 Years
STANDARD_DEVIATION 14.4 • n=39 Participants
|
58.6 Years
STANDARD_DEVIATION 14.2 • n=41 Participants
|
58.3 Years
STANDARD_DEVIATION 14.3 • n=35 Participants
|
|
Sex: Female, Male
Female
|
135 Participants
n=39 Participants
|
134 Participants
n=41 Participants
|
269 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
647 Participants
n=39 Participants
|
547 Participants
n=41 Participants
|
1194 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
182 Participants
n=39 Participants
|
175 Participants
n=41 Participants
|
357 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
600 Participants
n=39 Participants
|
506 Participants
n=41 Participants
|
1106 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
203 Participants
n=39 Participants
|
135 Participants
n=41 Participants
|
338 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
38 Participants
n=39 Participants
|
31 Participants
n=41 Participants
|
69 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
109 Participants
n=39 Participants
|
77 Participants
n=41 Participants
|
186 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
133 Participants
n=39 Participants
|
127 Participants
n=41 Participants
|
260 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
296 Participants
n=39 Participants
|
308 Participants
n=41 Participants
|
604 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
782 Participants
n=39 Participants
|
681 Participants
n=41 Participants
|
1463 Participants
n=35 Participants
|
|
Body Mass Index
|
31.5 kg/m2
STANDARD_DEVIATION 6.5 • n=39 Participants
|
31.5 kg/m2
STANDARD_DEVIATION 7.6 • n=41 Participants
|
31.5 kg/m2
STANDARD_DEVIATION 7.0 • n=35 Participants
|
|
Serum urate, mean
|
8.4 mg/dl
STANDARD_DEVIATION 1.6 • n=39 Participants
|
8.4 mg/dl
STANDARD_DEVIATION 1.6 • n=41 Participants
|
8.4 mg/dl
STANDARD_DEVIATION 1.6 • n=35 Participants
|
|
Serum creatinine, mean
|
1.16 mg/dl
STANDARD_DEVIATION .35 • n=39 Participants
|
1.16 mg/dl
STANDARD_DEVIATION .35 • n=41 Participants
|
1.16 mg/dl
STANDARD_DEVIATION .35 • n=35 Participants
|
|
Allopurinol dose, mean
|
188 mg/day
STANDARD_DEVIATION 101 • n=39 Participants
|
190 mg/day
STANDARD_DEVIATION 98 • n=41 Participants
|
189 mg/day
STANDARD_DEVIATION 100 • n=35 Participants
|
|
Colchicine use
|
419 Participants
n=39 Participants
|
375 Participants
n=41 Participants
|
794 Participants
n=35 Participants
|
|
Prescription NSAID use
|
385 Participants
n=39 Participants
|
350 Participants
n=41 Participants
|
735 Participants
n=35 Participants
|
|
Glucocorticoid use
|
293 Participants
n=39 Participants
|
251 Participants
n=41 Participants
|
544 Participants
n=35 Participants
|
|
Thiazide diuretic
|
71 Participants
n=39 Participants
|
80 Participants
n=41 Participants
|
151 Participants
n=35 Participants
|
|
Loop diurectic
|
68 Participants
n=39 Participants
|
47 Participants
n=41 Participants
|
115 Participants
n=35 Participants
|
|
Diabetes mellitus
|
170 Participants
n=39 Participants
|
157 Participants
n=41 Participants
|
327 Participants
n=35 Participants
|
|
hypertension
|
452 Participants
n=39 Participants
|
407 Participants
n=41 Participants
|
859 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 12 monthsAchievement of serum uric acid (sUA) \< 6.0 mg/dl at 1 year
Outcome measures
| Measure |
Usual Care
n=782 Participants
Participants recruited in this arm will receive their usual care for gout as they normally would
|
Intervention
n=681 Participants
Participants recruited to this arm will receive their usual gout care + pharmacist-led intervention
Pharmacist-Led Intervention: Pharmacists will conduct outreach primarily via an automated telephone interactive voice recognition system and direct (telephone) contact
|
|---|---|---|
|
sUA < 6.0 mg/dl at 1 Year
|
117 Participants
|
204 Participants
|
PRIMARY outcome
Timeframe: 12 monthsAdherence to prescribed medication
Outcome measures
| Measure |
Usual Care
n=782 Participants
Participants recruited in this arm will receive their usual care for gout as they normally would
|
Intervention
n=681 Participants
Participants recruited to this arm will receive their usual gout care + pharmacist-led intervention
Pharmacist-Led Intervention: Pharmacists will conduct outreach primarily via an automated telephone interactive voice recognition system and direct (telephone) contact
|
|---|---|---|
|
Adherence to Medication
|
250 Participants
|
341 Participants
|
Adverse Events
Usual Care
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Usual Care
n=782 participants at risk
Participants recruited in this arm will receive their usual care for gout as they normally would
|
Intervention
n=681 participants at risk
Participants recruited to this arm will receive their usual gout care + pharmacist-led intervention
Pharmacist-Led Intervention: Pharmacists will conduct outreach primarily via an automated telephone interactive voice recognition system and direct (telephone) contact
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necolysis (TENs)
|
0.13%
1/782 • Number of events 1 • 2 year study period
|
0.00%
0/681 • 2 year study period
|
|
Skin and subcutaneous tissue disorders
Drug rash with eosinophilia and systemic symptoms (DRESS)
|
0.00%
0/782 • 2 year study period
|
0.15%
1/681 • Number of events 1 • 2 year study period
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place