Trial Review

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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] 292424 0
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 304020 0
Condition category
Condition code
Metabolic and Endocrine 303350 303350 0 0
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] 298599 0
Lifestyle
Intervention code [2] 298787 0
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] 302739 0
HBA1c using serum sample
Timepoint [1] 302739 0
12 months
Secondary outcome [1] 336871 0
Mortality
Timepoint [1] 336871 0
12 months
Secondary outcome [2] 336872 0
Hospitalisation by review of medical records in general practice
Timepoint [2] 336872 0
12 months
Secondary outcome [3] 338296 0
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] 338296 0
12 months
Secondary outcome [4] 338297 0
Blood pressure as recorded in medical record
Timepoint [4] 338297 0
12 months
Secondary outcome [5] 338298 0
Lipids serum sample
Timepoint [5] 338298 0
12 months
Secondary outcome [6] 338299 0
Satisfaction with 'T2DM' care received in previous 12 months using the Hua Oranga Outcomes Measure
Timepoint [6] 338299 0
12 months
Secondary outcome [7] 338300 0
Goal Attainment Score
Timepoint [7] 338300 0
12 months
Secondary outcome [8] 338330 0
Health service utilisation ie number of visits to primary care providers to be obtained by GP medical records
Timepoint [8] 338330 0
12 months
Secondary outcome [9] 338504 0
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] 338504 0
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?
No
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
91
Final
Recruitment outside Australia
Country [1] 9051 0
New Zealand
State/province [1] 9051 0
Auckland and Northland

Funding & Sponsors
Funding source category [1] 296981 0
Government body
Name [1] 296981 0
Health Research Council
Country [1] 296981 0
New Zealand
Funding source category [2] 296983 0
Government body
Name [2] 296983 0
MBIE National Science Challenge - Healthier Lives
Country [2] 296983 0
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] 295982 0
University
Name [1] 295982 0
UniServices, University of Auckland
Address [1] 295982 0
Private Bag 92019
Victoria St West
Auckland 1142
Country [1] 295982 0
New Zealand
Secondary sponsor category [2] 295983 0
Commercial sector/Industry
Name [2] 295983 0
Synergia Ltd
Address [2] 295983 0
2 Hepburn St, Freemans Bay, Auckland 1011
Country [2] 295983 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298181 0
Northern B HDEC
Ethics committee address [1] 298181 0
Ethics committee country [1] 298181 0
New Zealand
Date submitted for ethics approval [1] 298181 0
19/09/2017
Approval date [1] 298181 0
04/01/2018
Ethics approval number [1] 298181 0
17/NTB/249

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

Contacts
Principal investigator
Name 76242 0
Dr Matire Harwood
Address 76242 0
National Hauora Coalition
Unit 1 Harbourside Business Park
485B Rosebank Road
Avondale
Auckland 1026
Country 76242 0
New Zealand
Phone 76242 0
+64 21 644898
Fax 76242 0
Email 76242 0
[email protected]
Contact person for public queries
Name 76243 0
Matire Harwood
Address 76243 0
National Hauora Coalition
Unit 1 Harbourside Business Park
485B Rosebank Road
Avondale
Auckland 1026
Country 76243 0
New Zealand
Phone 76243 0
+6421644898
Fax 76243 0
Email 76243 0
[email protected]
Contact person for scientific queries
Name 76244 0
Matire Harwood
Address 76244 0
National Hauora Coalition
Unit 1 Harbourside Business Park
485B Rosebank Road
Avondale
Auckland 1026
Country 76244 0
New Zealand
Phone 76244 0
+6421644898
Fax 76244 0
Email 76244 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseIndigenous health worker support for patients with poorly controlled type 2 diabetes: Study protocol for a cluster randomised controlled trial of the Mana Tu programme.2018https://dx.doi.org/10.1136/bmjopen-2017-019572
EmbaseThe experience of gestational diabetes for indigenous Maori women living in rural New Zealand: Qualitative research informing the development of decolonising interventions.2018https://dx.doi.org/10.1186/s12884-018-2103-8
N.B. These documents automatically identified may not have been verified by the study sponsor.