Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000761864p
Ethics application status
Submitted, not yet approved
Date submitted
15/03/2021
Date registered
18/06/2021
Date last updated
18/06/2021
Date data sharing statement initially provided
18/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Home based Education and Learning Program for Gout
Scientific title
The Feasibility of a Home based Education and Learning Program for Gout , as assessed by patient acceptability and serum urate
Secondary ID [1] 303697 0
NIl
Universal Trial Number (UTN)
Trial acronym
HELP Gout
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Gout 321112 0
Condition category
Condition code
Musculoskeletal 318907 318907 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Person centred structured educational intervention (PC-SEV): Two home visits (at weeks 2 and 6) of approximately 1 hour, will be undertaken to deliver individualised structured education focused around key messages that are determined a priori.

A health professional ( nurse or pharmacist) will visit the patients home, and deliver gout education, which will take into account factors such as the individuals level of pre existing knowledge, and educational background.

Patients will receive a personalised flare plan to follow during an acute attack of gout to avoid going to hospital. This will include developing an emergency management plan, which will be formulated by their physician, and take into account current medications, allergies, and volatility of their gout. They will also have access to a dedicated telephone service for advice from a rheumatologist, which they can call at their own discretion.

A summary booklet, designed for this study, will be provided as an ongoing reminder of the discussion and key messages.

A point of care serum urate will be measured during the home visit, and urate lowering therapy escalated according to a predefined dose escalation regimen, based on international recommendations (Khanna, D., Fitzgerald, J.D., Khanna, P.P., Bae, S., Singh, M.K., Neogi, T., Pillinger, M.H., Merill, J., Lee, S., Prakash, S., Kaldas, M., Gogia, M., Perez-Ruiz, F., Taylor, W., Lioté, F., Choi, H., Singh, J.A., Dalbeth, N., Kaplan, S., Niyyar, V., Jones, D., Yarows, S.A., Roessler, B., Kerr, G., King, C., Levy, G., Furst, D.E., Edwards, N.L., Mandell, B., Schumacher, H.R., Robbins, M., Wenger, N. and Terkeltaub, R. (2012), 2012 American College of Rheumatology guidelines for management of gout. Part 1: Systematic nonpharmacologic and pharmacologic therapeutic approaches to hyperuricemia. Arthritis Care Res, 64: 1431-1446.)

Fall in serum urate will be used as a surrogate of compliance.

The duration of the study is 16 weeks.
Intervention code [1] 319999 0
Behaviour
Intervention code [2] 320436 0
Prevention
Comparator / control treatment
Usual care.

No specific study intervention will occur. for example if the patient's gout is managed by their GP, or a rheumatologist at their local hospital, this will continue uninterrupted.
Control group
Active

Outcomes
Primary outcome [1] 326843 0
A participant survey administered at week 16 will be used to determine acceptability of interventions to participants.
Timepoint [1] 326843 0
16 weeks post-intervention commencement
Secondary outcome [1] 392872 0
number of withdrawals from study assessed by audit of study database
Timepoint [1] 392872 0
16 weeks post-intervention commencement
Secondary outcome [2] 392873 0
Formal serum urate at an accredited pathology laboratory. as an outcome measure will only be measured once at baseline and once at week 16. A point or serum urate will be measured at the home visits in the intervention arm as a tool to guide therapy, not to measure efficacy of the intervention.
Timepoint [2] 392873 0
16 weeks post-intervention commencement
Secondary outcome [3] 392874 0
Adverse Events, assessed in accordance with the Common Terminology Criteria for Adverse Events (CTCAE4)
Timepoint [3] 392874 0
16 weeks post-intervention commencement
Secondary outcome [4] 392876 0
the number of self-reported gout flares, using patient self reported information in the Gout Activity Questionnaire
Timepoint [4] 392876 0
16 weeks post-intervention commencement
Secondary outcome [5] 392877 0
Disease activity assessed using the Gout Activity Score
Timepoint [5] 392877 0
16 weeks post-intervention commencement
Secondary outcome [6] 392878 0
Disease-related knowledge assessed using the Gout Knowledge Questionnaire
Timepoint [6] 392878 0
16 weeks post-intervention commencement

Eligibility
Key inclusion criteria
Gout, meeting 2016 ACR classification criteria
English literate
Able to commit to study for 4 months
Males over 18 years of age, or post menopausal females
Residing in Australia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-independent living
Inability to give informed consent
Any condition in the opinion of the investigator that should exclude the participant.
Incarceration
Intolerant of allopurinol and feboxustat

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)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data will be collected using electronic case report forms. All data sheets will be password protected. For statistical analysis, an intention-to-treat approach will be taken, consistent with CONSORT guidelines. Baseline characteristics between groups will be analysed by unpaired t test or chi-squared tests. For the primary endpoint, groups will be compared using appropriate regression models. Safety data will be analysed by means of descriptive statistics.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/07/2021
Actual
Date of last participant enrolment
Anticipated
1/12/2021
Actual
Date of last data collection
Anticipated
1/04/2022
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 18930 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 18931 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 33434 0
6150 - Murdoch
Recruitment postcode(s) [2] 33435 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 308112 0
Charities/Societies/Foundations
Name [1] 308112 0
Arthritis Australia
Country [1] 308112 0
Australia
Primary sponsor type
Government body
Name
South Metropolitan Health Service
Address
Administration Building, Fiona Stanley Hospital
14 Barry Marshall Parade, Murdoch WA
6150
Country
Australia
Secondary sponsor category [1] 308866 0
None
Name [1] 308866 0
Address [1] 308866 0
Country [1] 308866 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308097 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 308097 0
Ethics committee country [1] 308097 0
Australia
Date submitted for ethics approval [1] 308097 0
03/05/2021
Approval date [1] 308097 0
Ethics approval number [1] 308097 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109526 0
Dr Helen Keen
Address 109526 0
Fiona Stanley Hospital
14 Barry Marshall Parade, Murdoch WA
6150
Country 109526 0
Australia
Phone 109526 0
+61 8 61521344
Fax 109526 0
Email 109526 0
[email protected]
Contact person for public queries
Name 109527 0
Daniel Lightowler
Address 109527 0
Fiona Stanley Hospital
14 Barry Marshall Parade, Murdoch WA
6150
Country 109527 0
Australia
Phone 109527 0
+61 8 61522222
Fax 109527 0
Email 109527 0
[email protected]
Contact person for scientific queries
Name 109528 0
Helen Keen
Address 109528 0
Fiona Stanley Hospital
14 Barry Marshall Parade, Murdoch WA
6150
Country 109528 0
Australia
Phone 109528 0
+61861521344
Fax 109528 0
Email 109528 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
On appropriate request to the investigators, and pending ethical approval, all de-identified individual participant data collected during the trial may be available on request.
When will data be available (start and end dates)?
On appropriate request to the investigators, and pending ethical approval, de-identified individual participant data may be available on request. This will be available from the date of data lock, for 7 years.
Available to whom?
Researchers
Available for what types of analyses?
Analyses that undergone further ethics approvals
How or where can data be obtained?
Contacting Dr Helen Keen
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11016Ethical approval  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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