search
Back to results

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

Primary Purpose

Gout

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Supported self-management
Usual care
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gout

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Western General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Supported self-management

Usual care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Proportion of participants achieving target urate levels (24 weeks)
Proportion of participants achieving serum urate level at, or below, 0.3mmol/l

Secondary Outcome Measures

Proportion of participants achieving target urate levels (52 weeks)
Proportion of participants achieving serum urate level at, or below, 0.3mmol/l
Flare frequency
Prospectively gathered number of days of self-reported gout flares
Size of tophi
The size in mm of the largest tophus at baseline (index tophus) will be measured at 52 weeks
Presence of tophi
The number of clinically evident tophi will be evaluated at 52 weeks
Patient reported quality of life using EQ-5D-5L
Prospectively gathered self-reported quality of life during/following gout flare evaluated using the EQ-5D-5L questionnaire.
Work absences
Prospectively gathered data on days lost at work due to gout flare
Healthcare utilisation
Prospectively gathered number of scheduled and unscheduled medical appointments/ hospital admissions due to gout
Self-reported medication compliance (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)
Self report of number of doses of medication omitted in preceding 2 weeks will be collected at 52 weeks
Medication compliance (24 weeks)
Plasma oxypurinol levels will be measured at 24 weeks.
Medication compliance (52 weeks)
Plasma oxypurinol levels will be measured at 52 weeks.

Full Information

First Posted
August 30, 2017
Last Updated
May 28, 2020
Sponsor
University of Edinburgh
search

1. Study Identification

Unique Protocol Identification Number
NCT03274063
Brief Title
Gout Self-Monitoring Aiming to Reach Target
Acronym
Gout-SMART
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 5, 2019 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Edinburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomised in a ratio of 2:1 to either supported self management or usual care.
Masking
Outcomes Assessor
Masking Description
Laboratory staff measuring biochemical traits will be blind to treatment allocation.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supported self-management
Arm Type
Active Comparator
Arm Description
Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing
Arm Title
Usual care
Arm Type
Sham Comparator
Arm Description
Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician.
Intervention Type
Other
Intervention Name(s)
Supported self-management
Intervention Description
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 .
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.
Primary Outcome Measure Information:
Title
Proportion of participants achieving target urate levels (24 weeks)
Description
Proportion of participants achieving serum urate level at, or below, 0.3mmol/l
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Proportion of participants achieving target urate levels (52 weeks)
Description
Proportion of participants achieving serum urate level at, or below, 0.3mmol/l
Time Frame
52 weeks
Title
Flare frequency
Description
Prospectively gathered number of days of self-reported gout flares
Time Frame
52 weeks
Title
Size of tophi
Description
The size in mm of the largest tophus at baseline (index tophus) will be measured at 52 weeks
Time Frame
52 weeks
Title
Presence of tophi
Description
The number of clinically evident tophi will be evaluated at 52 weeks
Time Frame
52 weeks
Title
Patient reported quality of life using EQ-5D-5L
Description
Prospectively gathered self-reported quality of life during/following gout flare evaluated using the EQ-5D-5L questionnaire.
Time Frame
52 weeks
Title
Work absences
Description
Prospectively gathered data on days lost at work due to gout flare
Time Frame
52 weeks
Title
Healthcare utilisation
Description
Prospectively gathered number of scheduled and unscheduled medical appointments/ hospital admissions due to gout
Time Frame
52 weeks
Title
Self-reported medication compliance (24 weeks)
Description
Self report of number of doses of medication omitted in preceding 2 weeks will be collected at 24 weeks.
Time Frame
24 weeks
Title
Self-reported medication compliance (52 weeks)
Description
Self report of number of doses of medication omitted in preceding 2 weeks will be collected at 52 weeks
Time Frame
52 weeks
Title
Medication compliance (24 weeks)
Description
Plasma oxypurinol levels will be measured at 24 weeks.
Time Frame
24 weeks
Title
Medication compliance (52 weeks)
Description
Plasma oxypurinol levels will be measured at 52 weeks.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip L Riches, FRCP PhD
Organizational Affiliation
University of Edinburgh/NHS Lothian
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available on request.
IPD Sharing Time Frame
Data will be available within 6 months of study completion.
IPD Sharing Access Criteria
Data access requests will be reviewed by the principal investigator. Requestors will be required to sign a data access agreement.

Learn more about this trial

Gout Self-Monitoring Aiming to Reach Target

We'll reach out to this number within 24 hrs