Gout Self-Monitoring Aiming to Reach Target

NCT03274063 | Completed Results

• 1 other identifier: GoutSMART_NHSL_2YCR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Target Urate Levels (24 Weeks)

  Percentage of participants achieving serum urate level at, or below, 0.3mmol/l

  24 weeks

Secondary Outcomes (7)

• Proportion of Participants Achieving Target Urate Levels (52 Weeks)

  52 weeks

• Flare Frequency

  52 weeks

• Presence of Tophi

  52 weeks

• EQ-5D-5L Quality of Life Score

  52 weeks

• Work Absences

  52 weeks

Study Arms (2)

Supported self-management

ACTIVE COMPARATOR

Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing

Other: Supported self-management

Usual care

SHAM COMPARATOR

Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician.

Other: Usual care

Interventions

Supported self-management OTHER

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 .

Supported self-management

Usual care OTHER

Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (Gout Self-monitoring Aiming to Reach Target urate) application.

You may not qualify if:

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

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Related Publications (1)

• Riches PL, Alexander D, Hauser B, Kuske B, Krause A. Evaluation of supported self-management in gout (GoutSMART): a randomised controlled feasibility trial. Lancet Rheumatol. 2022 May;4(5):e320-e328. doi: 10.1016/S2665-9913(22)00062-5. Epub 2022 Mar 24.

  PMID: 38294032 DERIVED

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr Philip Riches
• Organization: University of Edinburgh

priches@staffmail.ed.ac.uk

07944625313

Study Officials

• Philip L Riches, FRCP PhD

  University of Edinburgh/NHS Lothian

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Laboratory staff measuring biochemical traits will be blind to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Rheumatologist & Honorary Senior Lecturer

Model Details: Participants will be randomised in a ratio of 2:1 to either supported self management or usual care.

Study Record Dates

• First Submitted: August 30, 2017
• First Posted: September 6, 2017
• Study Start: April 5, 2019
• Primary Completion: March 19, 2021
• Study Completion: June 1, 2021
• Last Updated: May 21, 2024
• Results First Posted: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

GB (1)