ANZCTR - Registration

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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]

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

cardiovascular disease

Chronic obstructive pulmonary disease (COPD)

renal failure

diabetes

Condition category

Condition code

Reproductive Health and Childbirth

Antenatal care

Cardiovascular

Other cardiovascular diseases

Respiratory

Chronic obstructive pulmonary disease

Renal and Urogenital

Kidney disease

Metabolic and Endocrine

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]

Lifestyle

Intervention code [2]

Prevention

Comparator / control treatment

n/a

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Description/number of wellbeing needs of pregnant Maori women, determined by the responses in the hauora assessment specifically designed for this study.

Timepoint [1]

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]

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]

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]

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]

The information will be collected from the time period from consent up to 6 months after consent.

Secondary outcome [2]

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]

The information will be collected from the time period from consent up to 6 months after consent.

Secondary outcome [3]

immunisation status from the National Immunisation Register (NIR) cross checked against participant NHI numbers.

Timepoint [3]

The information will be collected from the time period from consent up to 6 months after consent.

Secondary outcome [4]

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]

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?

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

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Waikato

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council New Zealand

Address [1]

Health Research Council NZ
Level 3/110 Stanley Street,
Grafton,
Auckland 1010

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern B Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

04/06/2021

Approval date [1]

11/08/2021

Ethics approval number [1]

NZ/1/CC3A118

Summary

Brief summary

In order to achieve equity, health providers need to work in partnership with Maori to develop a responsive health system that also addresses the wider impacts on health. Using comprehensive wellbeing screening identifies issues that are important to Maori and that currently may not be addressed. This study allows the Waikato District Health Board to provide targeted support to where it is most needed by looking at two important stages of life – pregnancy and the adult age group when chronic disease becomes an important influence on life expectancy.  This project aims to identify health and wellbeing needs for these two groups by using a co-designed whanau (family) inclusive, holistic approach to assess and meet those needs.

Using a kaupapa Maori co-design process, we will partner with a range of collaborators.  Through community and whanau/patient consultation (focus groups & wananga) we will develop a hauora (wellbeing) assessment tool and programme.  We will then pilot the hauora assessment tool with 400 pregnant Maori women and 200 Maori with chronic disease (cardiovascular disease, diabetes, COPD, & renal disease), to assess their unmet needs. Finally, we will assess the results and co-design strategies and interventions to further meet the identified needs for these groups.

Trial website

Trial related presentations / publications

Public notes

Research Impact: The likelihood for findings from this research to be translated into Maori health gains is high with impact at many levels including Waikato DHB management, staff, community agencies, and for patients, whanau, hapu and iwi. Through the Harti Hauora Tamariki project, we have shown that we can change hospital systems and improve experiences for patients and whanau. There is a growing sense of urgency within Waikato DHB on the need to dramatically increase efforts to achieve equity for the 85,000 Maori living within the region.  We believe this research will provide immediate benefit for Maori in the Waikato as well as providing a powerful framework for the Ministry of Health, and other DHBs and agencies in addressing health equity. It will also provide a platform for future research to measure the impact of our approach on maternal, and ante and postnatal care.

Contacts

Principal investigator

Name

Prof Ross Lawrenson

Address

Waikato Medical Research Centre,
University of Waikato
Private Bag 3105,
Hamilton 3240

Country

New Zealand

Phone

+64 21471873

Fax

ross.lawrenson@waikato.ac.nz

Contact person for public queries

Name

Amy Jones

Address

Te Puna Oranga; Waikato District Health Board
Private Bag 3200,
Pembroke St,
Hamilton 3240

Country

New Zealand

Phone

+64 273439715

Fax

amy.jones2@waikatodhb.health.nz

Contact person for scientific queries

Name

Ross Lawrenson

Address

Waikato Medical Research Centre,
University of Waikato
Private Bag 3105,
Hamilton 3240

Country

New Zealand

Phone

+64 21471873

Fax

ross.lawrenson@waikato.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
13090	Study protocol					382668-(Uploaded-03-09-2021-12-09-05)-Study-related document.docx
13091	Ethical 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.

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