Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001481864
Ethics application status
Approved
Date submitted
8/09/2021
Date registered
29/10/2021
Date last updated
11/08/2024
Date data sharing statement initially provided
29/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Development of a hauora wellbeing assessment tool for wahine hapu (pregnant women) and Maori adults with long-term conditions
Scientific title
The determinants of health for Maori mothers and adults
with chronic diseases using a co-designed hauora wellbeing assessment tool
Secondary ID [1] 305140 0
Health Research Council Registration number 20/1178
Universal Trial Number (UTN)
U1111-1269-0440
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
antenatal health 323380 0
cardiovascular disease 323381 0
Chronic obstructive pulmonary disease (COPD) 323382 0
renal failure 323383 0
diabetes 323384 0
Condition category
Condition code
Reproductive Health and Childbirth 320954 320954 0 0
Antenatal care
Cardiovascular 320955 320955 0 0
Other cardiovascular diseases
Respiratory 320956 320956 0 0
Chronic obstructive pulmonary disease
Renal and Urogenital 320957 320957 0 0
Kidney disease
Metabolic and Endocrine 320958 320958 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name: Hauora assessment
Why: to assess health and wellbeing needs of the participant and support these needs
What: We plan to partner with a range of stakeholders to develop a hauora (wellbeing) assessment tool to assess and meet needs for wahine hapu, and Maori adults with chronic disease. The comprehensive wellbeing screening and support tool, the Hauora assessment, will have follow-up protocols for each question and will be administered by a trained Maori navigator to support whanau to access a range of services, including providing help when possible. For example, checking general practice (GP) enrolment and if not enrolled supporting enrolment, asking about smoking and supporting smoking cessation, healthy homes check (asking a few questions about whether the home is warm, dry, insulated and not overcrowded), cancer screening and immunisations as well as other identified relevant topics. These are yet to be determined through the co-design process.

The stakeholders for co-design will include: Waikato hospital clinicians working in maternity and with patients with chronic diseases, including doctors, nurses, dieticians, podiatrists, as well as other hospital staff working with these patients, e.g. kaitiaki (cultural support workers) and social workers. Other Waikato District Health Board (DHB) staff involved will include the General Practice (GP) liaisons, Whare ora (Health Homes) coordinator, stop smoking service coordinator, immunisations coordinator, family violence coordinator, cancer screening coordinator, and any other relevant service leaders/coordinators identified during the co-design process. We will also engage with community. This includes Maori health providers in the Waikato region, birth care centres and Maori antenatal program leads (there are currently 2 running in Hamilton/Waikato). Stakeholder engagement will generally include face to face or virtual meetings with each stakeholder to discuss the screening question and pathway/protocol as well as any issues/barriers or solutions for Maori patients (for approximately 1 hour). There may be more than 1 session with some stakeholders, depending on the complexity of the topic.
Lastly, we will run 4 focus groups with Maori mothers (both rural and Hamilton city) and 4 focus groups with patients with chronic disease (1 focus group per condition). All focus groups will run with approximately 7-10 people, for up to 2 hours. Each participant will sign a consent form before the focus group begins and be provided with a $100 supermarket voucher as koha/gift for their participation.
We will use a systems level approach to ensure all aspects of the hauora programme assessment tool are high quality, clinically safe, continuously improved and to advocate for change at multiple levels when required. This means that the tool will be updated and modified on an as-needed basis, e.g. if a participant, stakeholder or advisory group member identifies an area of concern. Modifications will be made and reviewed by the whole research team, along with stakeholder input where required, before they are implemented into the live version of the hauora assessment. We will not be monitoring adherence to the assessment tool but will collect data on questions completed, which will capture assessment completeness. We will also be measuring secondary outcomes to assess if certain protocols are completed successfully, e.g. enrolment with a GP or stop smoking service.

Who provided: The assessment will be administered by a trained Maori navigator to support whanau to access a range of services where needed. Training will for the navigator will include a combination of in-house training on the hauora assessment and other Waikato DHB or Ministry training associated with specific topics in the hauora assessment. For example, how to screen for family violence (Waikato DHB family violence coordinator runs 1 day training sessions on this), and the Ministry of Health NZ online smoking cessation training (1 hour). In-house training will include going over and role playing completing a hauora assessment with wider research team members (at least 3 practice sessions, approximately 1 hour each) and practicing with other members of the Maori Health service (at least 2, for approximately 30-40 min each time). There will also be a 1 hour session with the director of Tikanga (Maori protocol expert) or with a delegated person, to learn about approaching and engaging with Maori whanau and participants.

How: the assessment will be delivered face to face with an individual and their whanau will be present if they wish.
Where: For pregnant women: the assessment will take place in the community at the home or other chosen location of the participant if they are recruited from the community. For women recruited through maternity services at Waikato hospital the assessment may take place in a private room at the hospital or at the participants home.
Where: for those with chronic conditions: assessments will take place primarily at outpatient clinics for each condition on site at Waikato Hospital.

When and how much: the assessment will be conducted once at the time of recruitment. It is expected to take between 20-40 minutes to complete.
Modifications: the assessment will be co-designed from the start and it is expected that where needed modifications will be made to the intervention throughout the course of the trial. This will be informed by the research and co-design groups.
Intervention code [1] 321549 0
Lifestyle
Intervention code [2] 321941 0
Prevention
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328831 0
Description/number of wellbeing needs of pregnant Maori women, determined by the responses in the hauora assessment specifically designed for this study.
Timepoint [1] 328831 0
Taken at the time of doing the Hauora assessment with the participant, on the day. If the assessment is incomplete at that time, it should be completed within 7 days of starting the assessment.
Primary outcome [2] 329229 0
Description/number of wellbeing needs of adults with chronic disease, determined by the responses in the hauora assessment specifically designed for this study.
Timepoint [2] 329229 0
Taken at the time of doing the Hauora assessment with the participant, on the day. If the assessment is incomplete at that time, it should be completed within 7 days of starting the assessment.
Secondary outcome [1] 400557 0
GP enrolment from Primary Health Networks (PHO). This will be determined by data-linkage using National Health Idex (NHI) number to information kept each Waikato region PHO. The PHOs will send back data for any enrolled participants to confirm enrolment and date of enrolment.

Timepoint [1] 400557 0
The information will be collected from the time period from consent up to 6 months after consent.
Secondary outcome [2] 400558 0
Smoking cessation enrolment determined by data-linkage using NHI number to information kept by the local provider ‘Once and for all’ (Midlands Health Network).
Timepoint [2] 400558 0
The information will be collected from the time period from consent up to 6 months after consent.
Secondary outcome [3] 400559 0
immunisation status from the National Immunisation Register (NIR) cross checked against participant NHI numbers.
Timepoint [3] 400559 0
The information will be collected from the time period from consent up to 6 months after consent.
Secondary outcome [4] 401826 0
Smoking cessation quit attempt by data-linkage using NHI number to information on quit attempt (successful or not) kept by the local provider ‘Once and for all’ (Midlands Health Network). A successful quit attempt is defined by the provider as: Carbon dioxide (CO2) monitored smoke free for up to 4 weeks after starting the smoking cessation programme.
Timepoint [4] 401826 0
The information will be collected from the time period from consent up to 6 months after consent.

Eligibility
Key inclusion criteria
• Waikato DHB residents
• Adults aged 16 years of age and above
AND
• Maori wahine hapu attending antenatal clinics in the Waikato (Hapu Wananga and Plunket WHIRIHIA) AND/OR those presenting to Waikato hospital maternity services, or in the community (e.g. self referrals)
OR
• Maori attending cardiovascular disease (CVD) rehabilitation, diabetes care, COPD rehabilitation, and renal services at Waikato DHB hospitals
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients who have already entered the study
• Patients who are not eligible for publicly funded health care in New Zealand
• Patients with severe illness deemed by their medical team likely to die within six months.

Study design
Purpose of the study
Educational / counselling / training
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
Open (masking not used)
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
Completed
Date of first participant enrolment
Anticipated
28/11/2022
Actual
1/08/2023
Date of last participant enrolment
Anticipated
2/02/2024
Actual
17/06/2024
Date of last data collection
Anticipated
29/02/2024
Actual
28/06/2024
Sample size
Target
600
Accrual to date
Final
61
Recruitment outside Australia
Country [1] 24092 0
New Zealand
State/province [1] 24092 0
Waikato

Funding & Sponsors
Funding source category [1] 309533 0
Government body
Name [1] 309533 0
Health Research Council New Zealand
Country [1] 309533 0
New Zealand
Primary sponsor type
Hospital
Name
Waikato District Health Board
Address
Waikato District Health Board
Pembroke Street
Private Bag 3200
Hamilton 3240
Country
New Zealand
Secondary sponsor category [1] 310519 0
None
Name [1] 310519 0
Address [1] 310519 0
Country [1] 310519 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309315 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 309315 0
Ethics committee country [1] 309315 0
New Zealand
Date submitted for ethics approval [1] 309315 0
04/06/2021
Approval date [1] 309315 0
11/08/2021
Ethics approval number [1] 309315 0
NZ/1/CC3A118

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

Contacts
Principal investigator
Name 113730 0
Prof Ross Lawrenson
Address 113730 0
Waikato Medical Research Centre,
University of Waikato
Private Bag 3105,
Hamilton 3240
Country 113730 0
New Zealand
Phone 113730 0
+64 21471873
Fax 113730 0
Email 113730 0
[email protected]
Contact person for public queries
Name 113731 0
Amy Jones
Address 113731 0
Te Puna Oranga; Waikato District Health Board
Private Bag 3200,
Pembroke St,
Hamilton 3240
Country 113731 0
New Zealand
Phone 113731 0
+64 273439715
Fax 113731 0
Email 113731 0
[email protected]
Contact person for scientific queries
Name 113732 0
Ross Lawrenson
Address 113732 0
Waikato Medical Research Centre,
University of Waikato
Private Bag 3105,
Hamilton 3240
Country 113732 0
New Zealand
Phone 113732 0
+64 21471873
Fax 113732 0
Email 113732 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We will only publish anonymised data. IPD contains personal information which is not suitable for dissemination outside of the project.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13090Study protocol    382668-(Uploaded-03-09-2021-12-09-05)-Study-related document.docx
13091Ethical approval    Ethics approval letter attached 382668-(Uploaded-03-09-2021-12-09-05)-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.