ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001276347

Ethics application status

Approved

Date submitted

13/07/2017

Date registered

5/09/2017

Date last updated

10/04/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Mana Tu: how effective is a whanau ora approach to improve HbA1C levels in people with poorly controlled type 2 diabetes mellitus

Scientific title

Mana Tu: efficacy of a whanau ora approach program for improving management of type 2 diabetes in Maori and Pacific ethnicity adults

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1199-2699

Trial acronym

ManaTu

Linked study record

Not applicable

Health condition

Health condition(s) or problem(s) studied:

Type 2 Diabetes

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The 20 GP clinics at National Hauora Coalition have been stratified according to number of people with HBA1c >65 who are Maori, Pacific and living in quintile 5 neighbourhoods (clinics with 40+ potential participants only), location (urban and rural) and ‘type’ (Marae and mainstream-led). There are five pairs or 10 practices that meet these criteria. Practices are then randomised to either receive Mana Tu or to be the ‘control’ for 12 months. The control practices will receive usual care for 12 months. The intervention practices will receive Mana Tu for 12 months. At the end of the trial, the control practices will receive Mana Tu for 12 months. More information about Mana Tu is provided here.

Participants will receive an intervention called Mana Tu. Mana Tu comprises:
1. Case Management of‘poorly controlled’ type 2 DM and wider social issues for Maori and Pacific people by health workers called Kai Manaaki. Kai Manaaki will have minimum 5 years’ experience in the management of long term conditions and already working in primary care as community health worker, diabetes educator, primary mental health roles.
2. Integration of Case Management within general practice clinics
3. Support for the KM from a Network Hub. The Hub will support the KM in terms of information management (data is collected via a portal and analysed/reported by an IT team), training, administration and quality assurance

Case management (CM) is provided by health workers (called Kai Manaaki) who are located in general practices. The intervention (CM) is provided over a number of visits either in the practice or at the person's home.
i. Sampling and recruiting - A list of potential participants (ie Maori, Pacific and quintile 5 with known HBA1C >65 in the past 12 months) is provided to the general practice. The clinical champion at each practice confirms inclusion criteria are met and makes formal approach to potential participant to obtain consent for referral to Mana Tu. All referrals received from the general practice during that week will be assigned to KM within that clinic.
ii. Pre and Visit 1 (60-90 minutes). To occur within 3 months of the study commencing. KM contacts participant (and if requested their whanau) utilising the Hui Process to ensure culturally safe engagement. Verbal and written information about the programme, and its evaluation, will be provided prior to informed consent being obtained.
iii. Visit 2 (to occur within two weeks of visit 1) - A standardised Mana Tu Assessment (60-90 minutes) will be undertaken utilising standard queries for self-management of type 2 DM including: Clinical indicators – HBA1c, BP, renal function, lipids, CVDRA, oral health medication, health service utililisation, immunisations; Lifestyle factors – height, weight, nutrition, physical activity, smoking; Psycho-social measures – mood, stress, work, budgeting, whanau ora, QoL; Health literacy
This information will provide baseline assessment data as well as inform goal setting with participants and their whanau.
iv. Visit 3 (60 minutes to occur within 2 weeks of visit 2). KM will meet with person +/- whanau to complete their personalised Mana Tu Plan - a modified version of the NIA Self-management Plan. The plan will address self-management of risk factors and LTCs, attainment of goals and regular feedback to whanau, links with appropriate organisations for ongoing support.
v. Further visits (each lasting 30 -60 minutes) - Over the next six months, KM will support access to interventions based on the Mana Tu Plan, record progress, collect data, engage with primary care teams, participate in Hub and Quality Improvement activities. The frequency of visits will be determined by the Plan set by the participants working with the KM and at least monthly (though we anticipate this will be more frequent (weekly-fortnightly) in the beginning). From Month Nine, KM and participants will be planning for discharge from the programme so that the final visit occurs at 12 months when the Discharge Plan is provided and outcome data collected.

Intervention code [1]

Lifestyle

Intervention code [2]

Treatment: Other

Comparator / control treatment

The control group will receive 'usual care' for the period of the trial (that is 12 months). Usual care is:
1. 'Diabetes Annual Review (DAR)' with a primary care clinician - template completed by the clinician, includes annual HBA1c, renal function, BP check, retinopathy review and podiatry assessment. The primary care clinician has access to NZ-based guidelines with which he/she utilises to manage the results from the DAR.
2. Three monthly GP review for prescriptions.
3. Access to primary and secondary health care as required for acute health issues.

At the end of the trial, the practices in the control group will be offered the opportunity to enrol those patients who meet the criteria to receive Mana Tu (the intervention).

Control group

Active

Outcomes

Primary outcome [1]

HBA1c using serum sample

Timepoint [1]

12 months

Secondary outcome [1]

Mortality

Timepoint [1]

12 months

Secondary outcome [2]

Hospitalisation by review of medical records in general practice

Timepoint [2]

12 months

Secondary outcome [3]

Smoking Status using standard question asked of all patients in NZ "have you smoked tobacco in the past 30 days?" and answer is Yes or No

Timepoint [3]

12 months

Secondary outcome [4]

Blood pressure as recorded in medical record

Timepoint [4]

12 months

Secondary outcome [5]

Lipids serum sample

Timepoint [5]

12 months

Secondary outcome [6]

Satisfaction with 'T2DM' care received in previous 12 months using the Hua Oranga Outcomes Measure

Timepoint [6]

12 months

Secondary outcome [7]

Goal Attainment Score

Timepoint [7]

12 months

Secondary outcome [8]

Health service utilisation ie number of visits to primary care providers to be obtained by GP medical records

Timepoint [8]

12 months

Secondary outcome [9]

Barriers and facilitators to the implementation and uptake of Mana Tu will be evaluated in a qualitative part of the research where providers, funders and experts are interviewed or contribute to focus group discussion.

Timepoint [9]

Baseline and 12 months

Eligibility

Key inclusion criteria

HBA1c >65
Ethnicity Maori and/or Pacific
Enrolled with National Hauora Coalition PHO

Minimum age

18 Years

Maximum age

70 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Too unwell
Do not understand English
Expected to leave region within 2 years
Can not give informed consent

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Cluster randomised controlled trial. Clusters were randomised by central randomisation at a central administration site. The administrator at the central site was independent to the research, and practices were de-dientified to her (ie she allocated the intervention after coin tossing to either practice A or B, C or D etc)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using coin tossing

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Cluster randomised controlled trial for 10 GP clinics that belong to the National Hauora Coalition Primary Healthcare Organisation. Five clinics will be randomized to receive the intervention for 12 months and five practices will be the control group. The control group will receive the intervention after 12 months. The clinical champion at the 'intervention' practice will invite all people in that practice who meet inclusion criteria to participate in a 'lifestyle program' for type 2 diabetes until a maximum of 40 people are enrolled.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

With an ICC of 0.01, a sample size of 5 clusters for the intervention and control groups achieves 80% power to detect a difference of 6.038 between the group means when the SD is 16. We will use a Two-Sided T test with a significance level of 0.05.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

16/10/2017

Actual

15/03/2018

Date of last participant enrolment

Anticipated

30/06/2018

Actual

Date of last data collection

Anticipated

30/06/2019

Actual

Sample size

Target

400

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland and Northland

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council

Address [1]

PO Box 5541
Wellesley St
Auckland 1141

Country [1]

New Zealand

Funding source category [2]

Government body

Name [2]

MBIE National Science Challenge - Healthier Lives

Address [2]

15 Stout Street, Wellington 6011

PO Box 1473, Wellington 6140

Country [2]

New Zealand

Primary sponsor type

Other

Name

National Hauora Coalition

Address

National Hauora Coalition
Unit 1 Harbourside Business Park
485B Rosebank Road
Avondale
Auckland 1026

Country

New Zealand

Secondary sponsor category [1]

University

Name [1]

UniServices, University of Auckland

Address [1]

Private Bag 92019
Victoria St West
Auckland 1142

Country [1]

New Zealand

Secondary sponsor category [2]

Commercial sector/Industry

Name [2]

Synergia Ltd

Address [2]

2 Hepburn St, Freemans Bay, Auckland 1011

Country [2]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern B HDEC

Ethics committee address [1]

c/o 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]

19/09/2017

Approval date [1]

04/01/2018

Ethics approval number [1]

17/NTB/249

Summary

Brief summary

Diabetes is a long term condition in which there are significant ethnic and social disparities in prevalence and outcomes. There is huge scope to reduce diabetes inequalities however the complex nature of the condition means a comprehensive and sustained approach that tackles the wider determinants for causes, management and complications is required.
We propose to test Mana Tu, a programme that was co-designed with experts in long-term-conditions including clinicians, policy-makers, academics and importantly whanau living with diabetes. Mana Tu aims to improve the impact of clinical and lifestyle interventions for people with poorly controlled diabetes; and their whanau who are living with prediabetes. Mana Tu deploys skilled and supported Kaimanaaki-whanau (KM) in primary care practices. The KM are similar to Case Managers but instead they use a mana whanau approach and work with General Practice teams while being operationally supported by a central hub. The hub coordinates broader community and social service support systems for whanau, and provides training and quality improvement support, within a rich data environment. 
There are four parts to the research:
1.	Mana Tu for Clients – will measure clinical (including changes in HBA1c, hospital admission numbers) and other (satisfaction, goal attainment) outcomes in 400 people to receive Mana Tu over 18 months.
2.	Mana Tu the Service – will investigate the impact of Mana Tu on hospital and primary care services
3.	Implementing Mana Tu – will explore barriers and facilitators to the implementation and uptake of Mana Tu through qualitative research (interviews and focus groups).
4.	Integrating Mana Tu – will integrate the findings from the three other parts to understand the relationship between process and outcomes.  The findings will provide valuable information for future proposals of a similar nature.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Matire Harwood

Address

National Hauora Coalition
Unit 1 Harbourside Business Park
485B Rosebank Road
Avondale
Auckland 1026

Country

New Zealand

Phone

+64 21 644898

Fax

m.harwood@auckland.ac.nz

Contact person for public queries

Name

Matire Harwood

Address

National Hauora Coalition
Unit 1 Harbourside Business Park
485B Rosebank Road
Avondale
Auckland 1026

Country

New Zealand

Phone

+6421644898

Fax

m.harwood@auckland.ac.nz

Contact person for scientific queries

Name

Matire Harwood

Address

National Hauora Coalition
Unit 1 Harbourside Business Park
485B Rosebank Road
Avondale
Auckland 1026

Country

New Zealand

Phone

+6421644898

Fax

m.harwood@auckland.ac.nz

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Indigenous health worker support for patients with poorly controlled type 2 diabetes: Study protocol for a cluster randomised controlled trial of the Mana Tu programme.	2018	https://dx.doi.org/10.1136/bmjopen-2017-019572
Embase	The experience of gestational diabetes for indigenous Maori women living in rural New Zealand: Qualitative research informing the development of decolonising interventions.	2018	https://dx.doi.org/10.1186/s12884-018-2103-8

N.B. These documents automatically identified may not have been verified by the study sponsor.

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