Trial Outcomes & Findings for Gout Self-Monitoring Aiming to Reach Target (NCT NCT03274063)
NCT ID: NCT03274063
Last Updated: 2024-05-21
Results Overview
Percentage of participants achieving serum urate level at, or below, 0.3mmol/l
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
24 weeks
Results posted on
2024-05-21
Participant Flow
Participant milestones
| Measure |
Supported Self-management
Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing
Supported self-management: Participants will be supplied with urate self-testing kits. Participants will have a mobile phone application installed which will prompt the participant to perform urate self-testing, enable the clinical research team to advise on escalation of urate lowering therapy, and collect quality of life data .
|
Usual Care
Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician.
Usual care: Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
20
|
|
Overall Study
COMPLETED
|
36
|
18
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gout Self-Monitoring Aiming to Reach Target
Baseline characteristics by cohort
| Measure |
Supported Self-management
n=40 Participants
Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing
Supported self-management: Participants will be supplied with urate self-testing kits. Participants will have a mobile phone application installed which will prompt the participant to perform urate self-testing, enable the clinical research team to advise on escalation of urate lowering therapy, and collect quality of life data .
|
Usual Care
n=20 Participants
Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician.
Usual care: Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.0 years
STANDARD_DEVIATION 15.0 • n=99 Participants
|
52.6 years
STANDARD_DEVIATION 14.1 • n=107 Participants
|
52.8 years
STANDARD_DEVIATION 14.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
56 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
|
38 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
58 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
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
40 participants
n=99 Participants
|
20 participants
n=107 Participants
|
60 participants
n=206 Participants
|
|
Tophi
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Urate
|
0.47 mmol/L
STANDARD_DEVIATION 0.07 • n=99 Participants
|
0.51 mmol/L
STANDARD_DEVIATION 0.10 • n=107 Participants
|
0.48 mmol/L
STANDARD_DEVIATION 0.09 • n=206 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPercentage of participants achieving serum urate level at, or below, 0.3mmol/l
Outcome measures
| Measure |
Supported Self-management
n=40 Participants
Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing
Supported self-management: Participants will be supplied with urate self-testing kits. Participants will have a mobile phone application installed which will prompt the participant to perform urate self-testing, enable the clinical research team to advise on escalation of urate lowering therapy, and collect quality of life data .
|
Usual Care
n=20 Participants
Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician.
Usual care: Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.
|
|---|---|---|
|
Percentage of Participants Achieving Target Urate Levels (24 Weeks)
|
29 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 52 weeksProportion of participants achieving serum urate level at, or below, 0.3mmol/l
Outcome measures
| Measure |
Supported Self-management
n=40 Participants
Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing
Supported self-management: Participants will be supplied with urate self-testing kits. Participants will have a mobile phone application installed which will prompt the participant to perform urate self-testing, enable the clinical research team to advise on escalation of urate lowering therapy, and collect quality of life data .
|
Usual Care
n=20 Participants
Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician.
Usual care: Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.
|
|---|---|---|
|
Proportion of Participants Achieving Target Urate Levels (52 Weeks)
|
32 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 52 weeksNumber of self-reported gout flares (months 7 to 12)
Outcome measures
| Measure |
Supported Self-management
n=36 Participants
Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing
Supported self-management: Participants will be supplied with urate self-testing kits. Participants will have a mobile phone application installed which will prompt the participant to perform urate self-testing, enable the clinical research team to advise on escalation of urate lowering therapy, and collect quality of life data .
|
Usual Care
n=18 Participants
Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician.
Usual care: Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.
|
|---|---|---|
|
Flare Frequency
|
0.81 number of self-reported gout flares
Standard Deviation 1.06
|
2.06 number of self-reported gout flares
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 52 weeksPercentage of participants with tophi at 52 weeks
Outcome measures
| Measure |
Supported Self-management
n=36 Participants
Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing
Supported self-management: Participants will be supplied with urate self-testing kits. Participants will have a mobile phone application installed which will prompt the participant to perform urate self-testing, enable the clinical research team to advise on escalation of urate lowering therapy, and collect quality of life data .
|
Usual Care
n=18 Participants
Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician.
Usual care: Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.
|
|---|---|---|
|
Presence of Tophi
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Recording of quality of life data was incomplete in this study and only available at close in the number of participants shown. This limitation is acknowledged in the published article of this trial
EQ-5D-5L (EuroqQol-5 level-5 dimension) self-reported quality of life score. Maximum score of 100 represents best possible health, minimum score of 0 represents worst possible health.
Outcome measures
| Measure |
Supported Self-management
n=36 Participants
Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing
Supported self-management: Participants will be supplied with urate self-testing kits. Participants will have a mobile phone application installed which will prompt the participant to perform urate self-testing, enable the clinical research team to advise on escalation of urate lowering therapy, and collect quality of life data .
|
Usual Care
n=8 Participants
Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician.
Usual care: Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.
|
|---|---|---|
|
EQ-5D-5L Quality of Life Score
|
83.4 units on a scale
Standard Deviation 11.1
|
79.1 units on a scale
Standard Deviation 12
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Measure available only in participants completing study
Number of days lost at work due to gout flare
Outcome measures
| Measure |
Supported Self-management
n=36 Participants
Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing
Supported self-management: Participants will be supplied with urate self-testing kits. Participants will have a mobile phone application installed which will prompt the participant to perform urate self-testing, enable the clinical research team to advise on escalation of urate lowering therapy, and collect quality of life data .
|
Usual Care
n=18 Participants
Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician.
Usual care: Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.
|
|---|---|---|
|
Work Absences
|
0.24 number of work days lost
Standard Deviation 1.35
|
0.11 number of work days lost
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Measure available only in participants completing study
Number of scheduled and unscheduled medical appointments
Outcome measures
| Measure |
Supported Self-management
n=36 Participants
Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing
Supported self-management: Participants will be supplied with urate self-testing kits. Participants will have a mobile phone application installed which will prompt the participant to perform urate self-testing, enable the clinical research team to advise on escalation of urate lowering therapy, and collect quality of life data .
|
Usual Care
n=18 Participants
Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician.
Usual care: Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.
|
|---|---|---|
|
Healthcare Utilisation
|
0.083 Number of medical appointments
Standard Deviation 0.37
|
0.67 Number of medical appointments
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Measure available only in participants completing study
Number of doses of medication omitted in preceding 2 weeks by self-report at 24 weeks.
Outcome measures
| Measure |
Supported Self-management
n=36 Participants
Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing
Supported self-management: Participants will be supplied with urate self-testing kits. Participants will have a mobile phone application installed which will prompt the participant to perform urate self-testing, enable the clinical research team to advise on escalation of urate lowering therapy, and collect quality of life data .
|
Usual Care
n=18 Participants
Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician.
Usual care: Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.
|
|---|---|---|
|
Self-reported Medication Compliance (24 Weeks)
|
0.57 Number of doses missed
Standard Deviation 1.63
|
1.32 Number of doses missed
Standard Deviation 2.63
|
Adverse Events
Supported Self-management
Serious events: 3 serious events
Other events: 7 other events
Deaths: 1 deaths
Usual Care
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Supported Self-management
n=40 participants at risk
Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing
Supported self-management: Participants will be supplied with urate self-testing kits. Participants will have a mobile phone application installed which will prompt the participant to perform urate self-testing, enable the clinical research team to advise on escalation of urate lowering therapy, and collect quality of life data .
|
Usual Care
n=20 participants at risk
Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician.
Usual care: Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.
|
|---|---|---|
|
Vascular disorders
Cardiovascular accident
|
2.5%
1/40 • Number of events 1 • 1 year
|
0.00%
0/20 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Hip replacement
|
2.5%
1/40 • Number of events 1 • 1 year
|
0.00%
0/20 • 1 year
|
|
Gastrointestinal disorders
Bowel cancer
|
2.5%
1/40 • Number of events 1 • 1 year
|
0.00%
0/20 • 1 year
|
|
Musculoskeletal and connective tissue disorders
skull fracture
|
0.00%
0/40 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
skin rash
|
0.00%
0/40 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/40 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
acute kidney injury
|
0.00%
0/40 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Supported Self-management
n=40 participants at risk
Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing
Supported self-management: Participants will be supplied with urate self-testing kits. Participants will have a mobile phone application installed which will prompt the participant to perform urate self-testing, enable the clinical research team to advise on escalation of urate lowering therapy, and collect quality of life data .
|
Usual Care
n=20 participants at risk
Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician.
Usual care: Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.
|
|---|---|---|
|
Gastrointestinal disorders
abdo pain
|
12.5%
5/40 • Number of events 5 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
skin rash
|
5.0%
2/40 • Number of events 2 • 1 year
|
10.0%
2/20 • Number of events 2 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place