Gout Self-Monitoring Aiming to Reach Target (Gout-SMART)
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|ClinicalTrials.gov Identifier: NCT03274063|
Recruitment Status : Active, not recruiting
First Posted : September 6, 2017
Last Update Posted : May 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gout||Other: Supported self-management Other: Usual care||Not Applicable|
Gout is the most common cause of inflammatory arthritis with recurrent gout flares a cause of reduced quality of life, work absence and disability. Effective treatments are widely available and yet many patients never achieve control of their disease. Resolution of gout attacks requires sustained lowering of the levels of serum urate, which in practise is seldom achieved. A supported self-management approach to gout has been developed which incorporates self-testing of urate levels and a smartphone application that will prompt participants to self-test and allow clinical researchers to titrate urate lowering therapies.
The feasibility of this approach will be evaluated in patients with gout referred to secondary care. Participants will be randomised 2:1 to the intervention or a control group. The intervention group will be offered supported self-management incorporating self-testing of serum urate. The control group will receive usual care from their primary care physician. The primary outcome will be the proportion of patients achieving levels of serum urate at or below 0.3mmol/l by 6 months. Participants will be followed up for a total of 12 months to assess the broader health and economic impact of the intervention.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomised in a ratio of 2:1 to either supported self management or usual care.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Laboratory staff measuring biochemical traits will be blind to treatment allocation.|
|Official Title:||Gout Self-Monitoring Aiming to Reach Target Serum Urate (Gout-SMART): Feasibility Study of Supported Self-management of Gout in Secondary Care Patients Requiring Escalation of Urate Lowering Therapy|
|Actual Study Start Date :||April 5, 2019|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||April 2021|
Active Comparator: Supported self-management
Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing
Other: 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 .
Sham Comparator: Usual care
Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician.
Other: 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 (24 weeks) [ Time Frame: 24 weeks ]Proportion of participants achieving serum urate level at, or below, 0.3mmol/l
- Proportion of participants achieving target urate levels (52 weeks) [ Time Frame: 52 weeks ]Proportion of participants achieving serum urate level at, or below, 0.3mmol/l
- Flare frequency [ Time Frame: 52 weeks ]Prospectively gathered number of days of self-reported gout flares
- Size of tophi [ Time Frame: 52 weeks ]The size in mm of the largest tophus at baseline (index tophus) will be measured at 52 weeks
- Presence of tophi [ Time Frame: 52 weeks ]The number of clinically evident tophi will be evaluated at 52 weeks
- Patient reported quality of life using EQ-5D-5L [ Time Frame: 52 weeks ]Prospectively gathered self-reported quality of life during/following gout flare evaluated using the EQ-5D-5L questionnaire.
- Work absences [ Time Frame: 52 weeks ]Prospectively gathered data on days lost at work due to gout flare
- Healthcare utilisation [ Time Frame: 52 weeks ]Prospectively gathered number of scheduled and unscheduled medical appointments/ hospital admissions due to gout
- Self-reported medication compliance (24 weeks) [ Time Frame: 24 weeks ]Self report of number of doses of medication omitted in preceding 2 weeks will be collected at 24 weeks.
- Self-reported medication compliance (52 weeks) [ Time Frame: 52 weeks ]Self report of number of doses of medication omitted in preceding 2 weeks will be collected at 52 weeks
- Medication compliance (24 weeks) [ Time Frame: 24 weeks ]Plasma oxypurinol levels will be measured at 24 weeks.
- Medication compliance (52 weeks) [ Time Frame: 52 weeks ]Plasma oxypurinol levels will be measured at 52 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274063
|Western General Hospital|
|Edinburgh, United Kingdom, EH4 2XU|
|Principal Investigator:||Philip L Riches, FRCP PhD||University of Edinburgh/NHS Lothian|