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Gout Self-Monitoring Aiming to Reach Target (Gout-SMART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03274063
Recruitment Status : Active, not recruiting
First Posted : September 6, 2017
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Philip Riches, University of Edinburgh

Brief Summary:
This study evaluates whether a supported self-management approach to gout is able to achieve target levels of serum urate, and better control of gout flares.

Condition or disease Intervention/treatment Phase
Gout Other: Supported self-management Other: Usual care Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Flare frequency [ Time Frame: 52 weeks ]
    Prospectively gathered number of days of self-reported gout flares

  3. 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

  4. Presence of tophi [ Time Frame: 52 weeks ]
    The number of clinically evident tophi will be evaluated at 52 weeks

  5. 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.

  6. Work absences [ Time Frame: 52 weeks ]
    Prospectively gathered data on days lost at work due to gout flare

  7. Healthcare utilisation [ Time Frame: 52 weeks ]
    Prospectively gathered number of scheduled and unscheduled medical appointments/ hospital admissions due to gout

  8. 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.

  9. 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

  10. Medication compliance (24 weeks) [ Time Frame: 24 weeks ]
    Plasma oxypurinol levels will be measured at 24 weeks.

  11. Medication compliance (52 weeks) [ Time Frame: 52 weeks ]
    Plasma oxypurinol levels will be measured at 52 weeks.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of gout (as per American College of Rheumatology criteria)
  • Physician recommendation that escalation of urate lowering therapy with allopurinol or febuxostat is appropriate.
  • Serum urate >0.36mm/L.
  • Patient has a mobile phone and is able to install GoutSMART application.

Exclusion Criteria:

  • Subject is unable to provide consent
  • Severe renal failure (eGFR <30) or established liver disease
  • Previous adverse reaction to allopurinol or febuxostat

Information from the National Library of Medicine

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


Locations
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United Kingdom
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Sponsors and Collaborators
University of Edinburgh
Investigators
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Principal Investigator: Philip L Riches, FRCP PhD University of Edinburgh/NHS Lothian
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Responsible Party: Philip Riches, Consultant Rheumatologist & Honorary Senior Lecturer, University of Edinburgh
ClinicalTrials.gov Identifier: NCT03274063    
Other Study ID Numbers: GoutSMART_NHSL_2YCR
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available on request.
Supporting Materials: Study Protocol
Time Frame: Data will be available within 6 months of study completion.
Access Criteria: Data access requests will be reviewed by the principal investigator. Requestors will be required to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases