Trial registered on ANZCTR


Trial ID
ACTRN12616000455460
Ethics application status
Approved
Date submitted
2/04/2016
Date registered
7/04/2016
Date last updated
4/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Using technology to manage gout
Scientific title
Patient-centred eHealth approach to improving outcomes for gout sufferers
Secondary ID [1] 288881 0
None
Universal Trial Number (UTN)
U1111-1181-3934
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 298179 0
Condition category
Condition code
Musculoskeletal 298343 298343 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 298411 298411 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The eHealth intervention is a self-management tool which will be provided to the intervention group participants. The eHealth app will be accessed through the Internet using a computer or mobile smart-device. It is designed to promote adherence to urate-lowering therapy by providing timely medical reminders, access to educational resources, and reporting attacks and adverse events. The intervention period for which participants have access to the app is 12 months.

Functions of the eHealth intervention:
- Promoting ULT adherence
Plasma urate concentrations will be presented over time in relation to target plasma urate (equal to or less than 0.36 mmol/L) to indicate the individual's risk of gout and highlighting level of risk.

-Providing patient education
The eHealth app will provide access to high quality education about gout and its management for gout patients. The importance of ULT will be emphasised.

-Reminder alerts
When patients are 'in the red' i.e. at high risk, alerts will be sent to remind patients to:
1) Take their ULT
2) Refill their prescriptions
3) Have blood tests for plasma urate (also test if due)
4) See their GP as urate concentration is out of range
5) Enter data regarding attacks

Sites: GP practices within Sydney, NSW, Australia

Data collection: GPs and their respective patients will be allocated to control (current standard care of gout) or intervention (use of eHealth gout management tool). Patient data will be collected at baseline and at intervals for one year (6 and 12 months). In addition to demographic data, medical history of gout (onset, frequency of attacks, treatments), alcohol history, medications (especially diuretics and low dose aspirin), co-morbidities (cardiovascular, renal, endocrine) and medical examination details (weight, height, blood pressure) will be collected. Pathology data will include renal function (plasma creatinine and eGFR) and plasma urate concentration.

Medical examination and pathology data will be collected from patients' medical records. Demographic data will be collected through use of a questionnaire. For the intervention group, gout monitoring data (i.e. urates, attacks) will be collected from the eHealth app that the patient uses to record this information. For the control group, that data will be collected from GP records. For both groups, researchers will review GP, pathology and PBS records at 6-month intervals for intervention and control patients to identify gout attacks, plasma urate concentrations, ULT dosages and adverse events. These data will be compared to the eHealth app and Diary data.
Intervention code [1] 294339 0
Behaviour
Intervention code [2] 294395 0
Treatment: Devices
Intervention code [3] 294396 0
Treatment: Other
Comparator / control treatment
Usual care - patients receiving routine care for prevention or treatment of their gout including GP visits.
Control group
Active

Outcomes
Primary outcome [1] 297812 0
Achievement of plasma urate of 0.36 mmol/L or less
Timepoint [1] 297812 0
The timepoints are 6 and 12 months post randomisation. The trial will last 12 months.
Secondary outcome [1] 322320 0
Frequency of acute gout attacks. The patient will use a rating scale and categories to record attacks via the app (scales and categories are yet to be developed)
Timepoint [1] 322320 0
The timepoints are 6 and 12 months post randomisation.
Secondary outcome [2] 322552 0
Quality of life as indicated by standardised survey (yet to be determined)
Timepoint [2] 322552 0
The timepoints are 6 and 12 months post randomisation.
Secondary outcome [3] 322553 0
Cost effectiveness of the intervention (DALYs)
Timepoint [3] 322553 0
12 months post randomisation.

Eligibility
Key inclusion criteria
- Adult (>18 yrs)
- Diagnosis of gout by GP (either new or flare up) and have experienced at least two attacks of acute gout in the previous year
- Receiving ULT treatment or candidate to start ULT treatment
- Regular access to a smartphone device, the Internet and able to download mobile phone applications (apps)
- Sufficient English language to complete questionnaires
- Provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant or intending to become pregnant during the study
- Psychological condition (i.e. cognitive decline) that may impede participation in the study
- Lack of technological experience so that participation in the study would be difficult

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1 to 1 randomisation - simple randomisation using randomisation table from a statistics book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
n our study, GP practices are randomised to either intervention or control. By comparison with similar cluster randomised studies in Australian general practice, we have selected an intra-class correlation of 0.01 for the primary outcome (i.e. achievement of the target plasma urate concentration (less than or equal to 0.36 mmol/L) at 6 months. On average, we expect to recruit 5 patients per practice. Allowing for 20% dropout over the course of 1 year, we will have on average 4 patients for analysis in each practice. For the sample size estimation, we have estimated that 50 plus or minus 15% i.e. 35-65% of subjects will achieve sustained target urate concentrations. Although there are a few studies published on the effect sizes for interventions centred on eHealth tools, given the potential to eliminate gout if the target is reached, this study will attempt to demonstrate an ambitious effect size of 0.7 i.e. 60-100% of intervention subjects will achieve the target. We have powered our study accordingly.To be conservative, we adopted the scenario which requires the largest sample size i.e. a sample of 96 patients in 24 intervention practices is required to detect a difference of 25% between pre-intervention (35%) and post-intervention (60%) cohorts, with 90% power for a two-sided test and 5% significance. In total a minimum of 192 patients from 48 practices will be recruited for the study. Conservatively, we will aim for 100 patients for both the intervention and control groups respectively.

The study analysis will be according to the ‘intention to treat’ principle. The groups will be compared using the method of general estimating equations, for each outcome, to account for the correlation within practices. The effects on adherence will be explored and correlations with primary and secondary outcomes sought. Adherence data will be accessed for participants from Healthy.me diaries and the Pharmaceutical Benefits Scheme.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 12992 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 293231 0
Government body
Name [1] 293231 0
National Health and Medical Research Council
Address [1] 293231 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 293231 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
St Vincent’s Clinical School | UNSW Australia
Department of Clinical Pharmacology and Toxicology
Therapeutics Centre | Level 2 Xavier Building
St Vincent’s Hospital
Victoria Street | Darlinghurst NSW 2010 | Australia
Country
Australia
Secondary sponsor category [1] 292034 0
None
Name [1] 292034 0
None
Address [1] 292034 0
Country [1] 292034 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294711 0
University of New South Wales Human Research Ethics Comittee
Ethics committee address [1] 294711 0
Research Ethics and Compliance Support (RECS)
University of New South Wales
Level 3, Rupert Myers Building (South Wing)
Sydney NSW 2052
Ethics committee country [1] 294711 0
Australia
Date submitted for ethics approval [1] 294711 0
15/04/2016
Approval date [1] 294711 0
27/05/2016
Ethics approval number [1] 294711 0

Summary
Brief summary
We propose a cluster randomised controlled trial to compare outcomes from standard gout care with those following provision on an eHealth intervention to gout patients and their general practitioners (GPs). This intervention is designed to promote adherence to urate lowering therapy (ULT) by providing timely reminders to have plasma uric acid measured, pick up prescriptions, and visit the GP, as well as reporting attacks and adverse effects.

We will target two behaviours to drive significant change in outcomes for gout:
1) Patient's adherence to ULT therapy
2) GP's prescribing of a dose of ULT that achieves the target plasma rate

Our eHealth intervention will provide personal feedback to patients about their plasma urate in relation to the target urate concentration. The intervention is designed to facilitate communication and information sharing between GPs and their patients, and increasing patient's knowledge of gout and the goal of treatment. The improved understanding of their condition is anticipated to increase patients' adherence to treatment to reach and maintain target urate concentrations. Importantly, GPs will also receive feedback linked to their patients' progress with respect to achieving and sustaining target plasma urate concentrations. This will help GPs to select the right dose of ULT and to reinforce the importance of adherence to ULT.
Trial website
To be established
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64778 0
Prof Richard Day
Address 64778 0
St Vincent’s Clinical School, UNSW Australia
Department of Clinical Pharmacology and Toxicology
Therapeutics Centre, Level 2 Xavier Building
St Vincent’s Hospital
Victoria Street, Darlinghurst NSW 2010
Country 64778 0
Australia
Phone 64778 0
+61 2 8382 2331
Fax 64778 0
Email 64778 0
r.day@unsw.edu.au
Contact person for public queries
Name 64779 0
Dr Amy Nguyen
Address 64779 0
St Vincent’s Clinical School, UNSW Australia
Department of Clinical Pharmacology and Toxicology
Therapeutics Centre, Level 2 Xavier Building
St Vincent’s Hospital
Victoria Street, Darlinghurst NSW 2010
Country 64779 0
Australia
Phone 64779 0
+61 2 8382 2199
Fax 64779 0
Email 64779 0
amy.nguyen@unsw.edu.au
Contact person for scientific queries
Name 64780 0
Dr Amy Nguyen
Address 64780 0
St Vincent’s Clinical School, UNSW Australia
Department of Clinical Pharmacology and Toxicology
Therapeutics Centre, Level 2 Xavier Building
St Vincent’s Hospital
Victoria Street, Darlinghurst NSW 2010
Country 64780 0
Australia
Phone 64780 0
+61 2 8382 2199
Fax 64780 0
Email 64780 0
amy.nguyen@unsw.edu.au