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Trial registered on ANZCTR


Registration number
ACTRN12622000278730
Ethics application status
Approved
Date submitted
6/11/2021
Date registered
15/02/2022
Date last updated
15/02/2022
Date data sharing statement initially provided
15/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Pasifika Intervention on uptake of urate-lowering therapy
Scientific title
Effect of Pasifika Intervention on uptake of urate-lowering therapy in Pasifika individuals with gout
Secondary ID [1] 305345 0
‘Nil known’
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 323686 0
Gout management - Lower uptake of urate-lowering therapy (allopurinol ) among Pacific 323687 0
Condition category
Condition code
Musculoskeletal 321220 321220 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to develop, design, implement and evaluate a new innovative intervention to improve urate-lowering therapy uptake by Pasifika in South Auckland.

This study is governed by the Pacific research methodology Fa’afaletui which enables an approach that focuses on the importance of considering different perspectives. A co-design approach will be utilised where the participants work together alongside researchers to develop and construct the new intervention. Therefore, although the intervention has not been developed the following phases (phase two and three) will describe the designing, developing, implementation and evaluation of the new innovative intervention.

Phase 2: This phase involves the designing of the intervention and developing the implementation plan. The anticipated overall duration for this phase is 12 months. A stocktake of Aotearoa New Zealand gout programmes, including those not published in the peer-reviewed published literature, and a recent systematic review of interventions to improve the uptake of urate lowering therapy (ULT) undertaken by Masters in Health Leadership student Iqbal Gill will be utilised to provide a user-friendly summary of the types of complex interventions to inform key stakeholders on what has already been tried, and what has been shown to be effective in different contexts.

This information will then be used to develop the study intervention by informing participants/co-researchers about existing ULT interventions and their effectiveness through concise easy-to-understand information-sharing (i.e power point, story boards etc).

A series of workshops (anticipated to be 2 or 3) will be conducted with all members of the Pacific Peoples Health Advisory Group (PPHAG), the Pacific Practice-Based Research Network (PPBRN), Alliance Health Plus (AH+) and other key stakeholders. These workshops are expected to run throughout the day.

• The Pacific People’s Health Advisory Group (PPHAG): This group comprises male and female community members aged in their 20s to their 70s, of mixed Pacific ethnicities (Samoan, Tongan, Niuean) with a range of occupations including nursing student, teacher, social worker, broadcaster and retiree.

• Pacific Practice-Based Research Network (PPBRN): Is comprised of all PBRN research officers (who include general practitioners, nurses, and receptionists depending on the practice) from South Auckland practices in the Network.

• Patients with gout and their families: PPBRN practices will recruit Pacific patients diagnosed with gout, aged 20 years and over, both those successfully using ULT, and those who have been unable to take, or regularly maintain its use. The invitation will also be extended to their extended family members who would like to participate. We will use purposive sampling aiming for diversity of Pacific ethnicities, ages and other key characteristics of these participants.

• Other relevant stakeholders: Invitations to participate will be extended to other relevant stakeholders including community pharmacists, Primary Health Organisation (PHO) personnel, community members and/or others identified during the course of the study.

The workshops will be facilitated by six members from the Pacific Gout research team:
• 1 x Senior Lecturer with experience in Pacific community health, health promotion and community engagement.
• 2x General Practitioners with vast experience in teaching, general practice and Pacific health research.
• 1x Post-doc Research Fellow
• 1x Doctoral student (recently submitted)

Workshops will take place in-person if at all possible, at a venue which best suits the participants. Pacific patients and families will be engaged using appropriate cultural processes and protocols. Talanga (interactive talk with a purpose) will be used to ensure two-way dialogue takes place when communicating with Pacific people. Where relevant, focus groups will be gender-specific, to protect the sacred nature of the ‘va’ (relationship of mutual respect) between male and female.

Participants in the workshops will then brainstorm possible new ways to address the problem, including possible sites where this might occur (eg health centre, pharmacy, church, workplace), and personnel who will lead the intervention (eg nurse, pharmacist, community worker, lay person, GP). Qualitative enquiry using nominal group technique will help guide the discussions to ensure all voices are heard. Although face-to-face workshops are preferred and prioritized for this project, other options such as virtual zoom workshops have been planned and put in place in case of unforeseen circumstances such as general health recommendations during the global pandemic.

Once an intervention has been drafted, PPHAG, PPBRN and researchers will collectively refine it through workshopping and other digital communications with key stakeholders into a strategy that can be implemented in South Auckland. Factors to be addressed in the intervention include what components it entails (eg health promotion, education, prescribing, dispensing, serum urate monitoring, patient reminders, family/whanau involvement), who leads it (eg doctor, nurse, pharmacist, team, community-led), and where it takes place (eg health premises, community location).

Implementation plan
A framework to map the intervention implementation will be developed. A logic model of change (a graphic representation of the relationship between the intervention, mechanisms of change, and behavioural and health outcomes), will be created using an intervention mapping framework. The logic model will define the inputs (resources, investment needed to implement intervention), key activities (tasks needed to successfully implement the intervention), outputs (measures to be made to demonstrate that the activities have been undertaken) and short-term outcomes (changes expected to result).

Phase 3: Intervention implementation and Evaluation
The intervention will then be trialled in South Auckland and tested to see how well it works. It is anticipated to start two months after Phase 2. Precise details of the evaluation will depend on the nature of the novel intervention and its characteristics. The intervention will be evaluated over a nine-month period (up to three three-month prescribing cycles for ULT).

Study approach
This Phase will use an implementation science approach, which is a systematic study of the activities that facilitate the successful uptake of an evidence-based health intervention, in this case a strategy and programme to improve ULT amongst Pasifika with gout in South Auckland. The design of the evaluation of the intervention implementation will be underpinned by a theoretical framework and informed by behavioural change theory, whereby a person’s attitudes, personal or subjective norms and their perceived behaviour controls (not doing what they think is wrong) shape an individual’s behavioural intentions and hence their actual behaviours.
Intervention code [1] 321788 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329056 0
Regular prescriptions of gout specific urate lowering therapy determined by data linkage to medical records.
Timepoint [1] 329056 0
3 months post-enrolment; 9 months post-intervention
Primary outcome [2] 330158 0
Serum urate testing results during the evaluation period determined by data linkage to medical records.
Timepoint [2] 330158 0
3 months post-enrolment; 9 months post-intervention
Primary outcome [3] 330159 0
Hospitalisations for gout determined by data linkage to medical records.
Timepoint [3] 330159 0
3 months post-enrolment; 9 months post-intervention
Secondary outcome [1] 401293 0
Identify acceptability of intervention delivery. This will be collected in the form of survey responses (eg Likert scale, free text or both).
Timepoint [1] 401293 0
3 and 6 months post-intervention
Secondary outcome [2] 406184 0
Identify feasibility of intervention delivery. This will be collected in the form of survey responses (eg Likert scale, free text or both).
Timepoint [2] 406184 0
3 and 6 months post-intervention
Secondary outcome [3] 406185 0
Identify enablers of intervention delivery. This will be collected in the form of survey responses (eg Likert scale, free text or both).
Timepoint [3] 406185 0
3 and 6 months post-intervention
Secondary outcome [4] 406186 0
Identify barriers of intervention delivery. This will be collected in the form of survey responses (eg Likert scale, free text or both).
Timepoint [4] 406186 0
3 and 6 months post-intervention
Secondary outcome [5] 406187 0
Determine the frequency of intervention delivery. This will be collected in the form of survey responses (eg Likert scale, free text or both).
Timepoint [5] 406187 0
3 and 6 months post-intervention
Secondary outcome [6] 406188 0
Determine the duration of events that facilitated the delivery of the intervention. This will be collected in the form of survey responses (eg Likert scale, free text or both).
Timepoint [6] 406188 0
3 and 6 months post-intervention
Secondary outcome [7] 406189 0
Determine the duration of events that impeded the delivery of the intervention. This will be collected in the form of survey responses (eg Likert scale, free text or both).
Timepoint [7] 406189 0
3 and 6 months post-intervention
Secondary outcome [8] 406190 0
Determine the costings of events that facilitated the delivery of the intervention. This will be collected in the form of survey responses (eg Likert scale, free text or both).
Timepoint [8] 406190 0
3 and 6 months post-intervention
Secondary outcome [9] 406191 0
Determine the costings of events that impeded the delivery of the intervention. This will be collected in the form of survey responses (eg Likert scale, free text or both).
Timepoint [9] 406191 0
3 and 6 months post-intervention
Secondary outcome [10] 406192 0
Identify other factors that may impact on the delivery of the intervention. This will be collected in the form of survey responses (eg Likert scale, free text or both).
Timepoint [10] 406192 0
3 and 6 months post-intervention

Eligibility
Key inclusion criteria
All patients aged 20 years or older with a diagnosis of gout.
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who were not meeting the study gout criteria/classification (SUA levels <360 µmol/L)
Participants aged <20 years.
Participants who are not able to give to consent.
Participants with a terminal or severe illness.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis




Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2023
Actual
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
31/03/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 24146 0
New Zealand
State/province [1] 24146 0
South Auckland

Funding & Sponsors
Funding source category [1] 309715 0
Government body
Name [1] 309715 0
Health Research Council of New Zealand
Country [1] 309715 0
New Zealand
Primary sponsor type
Individual
Name
Dr Malakai Ofanoa
Address
The Pacific Health Department, School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
M&HS Building 507 - Bldg 507
Level B, Room B005
28 Park Avenue
Grafton
Auckland 1023
New Zealand
Country
New Zealand
Secondary sponsor category [1] 310735 0
Individual
Name [1] 310735 0
Professor Felicity Goodyear-Smith
Address [1] 310735 0
Department of General Practice and Primary Healthcare, School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
M&HS Building 507 - Bldg 507
Level 3, Room 3018
28 Park Avenue
Grafton
Auckland 1023
New Zealand
Country [1] 310735 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309478 0
Auckland Health Research Ethics Committee (AHREC)
Ethics committee address [1] 309478 0
The Auckland Health Research Ethics Committee (AHREC)
20 Symond Street
Auckland 1010
New Zealand
The University of Auckland,
Ethics committee country [1] 309478 0
New Zealand
Date submitted for ethics approval [1] 309478 0
21/08/2021
Approval date [1] 309478 0
16/09/2021
Ethics approval number [1] 309478 0
Reference number: AH22873

Summary
Brief summary
Building on previous knowledge about gout and urate lowering therapy, a new innovative intervention will be designed, implemented and evaluated to improve urate-lowering therapy uptake by Pasifika in South Auckland.

The study will employ mixed methodology (quantitative and qualitative) based on the Samoan Fa'afaletui framework. This approach focuses on the importance of considering different perspectives in research, including ‘people at the top of the mountain’ (for example, a national overview) ‘at the top of the tree’ (regional perspective), who bring long- and middle-distance lenses to the issue, and the ‘man in a canoe fishing’, who is closest to the ‘school of fish’, and most affected by the problem (community members, patients, primary care clinicians). Phase 1 has been described in a separate observational study registration form.

Phase 2: To develop the intervention, a series of workshops (anticipated to be 2 or 3) will be conducted with members of the Pacific Peoples Health Advisory Group (PPHAG) , the Pacific Practice-Based Research Network PPBRN), Alliance Health Plus (AH+) and other key stakeholders. A concise, user-friendly summary of the types of complex interventions which have already been already been tried, and what has been shown to be effective in different contexts, will help inform the development. The new intervention will be designed through qualitative enquiry using nominal group technique where possible to ensure all voices are heard.

Phase 3: The intervention will then be trialled in South Auckland, and tested to see how well it works.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114282 0
Dr Malakai Ofanoa
Address 114282 0
The Pacific Health Department, School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
M&HS Building 507 - Bldg 507
Level B, Room B005
28 Park Avenue
Grafton
Auckland 1023
New Zealand
Country 114282 0
New Zealand
Phone 114282 0
+64 9 923 2997
Fax 114282 0
Email 114282 0
m.ofanoa@auckland.ac.nz
Contact person for public queries
Name 114283 0
Dr Malakai Ofanoa
Address 114283 0
The Pacific Health Department, School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
M&HS Building 507 - Bldg 507
Level B, Room B005
28 Park Avenue
Grafton
Auckland 1023
New Zealand
Country 114283 0
New Zealand
Phone 114283 0
+64 9 923 2997
Fax 114283 0
Email 114283 0
m.ofanoa@auckland.ac.nz
Contact person for scientific queries
Name 114284 0
Prof Felicity Goodyear-Smith
Address 114284 0
Department of General Practice and Primary Healthcare, School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
M&HS Building 507 - Bldg 507
Level 3, Room 3018
28 Park Avenue
Grafton
Auckland 1023
New Zealand
Country 114284 0
New Zealand
Phone 114284 0
+64 9 923 2357
Fax 114284 0
Email 114284 0
f.goodyear-smith@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13356Study protocol    382806-(Uploaded-24-09-2021-13-57-24)-Study-related document.docx
13357Informed consent form    382806-(Uploaded-24-09-2021-13-57-47)-Study-related document.pdf
13358Ethical approval    382806-(Uploaded-24-09-2021-13-58-17)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.