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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001276347
Acronym
ManaTu
Enrollment
91
Registered
2017-09-05
Start date
2018-03-15
Completion date
2018-06-30
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

National Hauora Coalition
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 22, 2026