PMID- 30552239 OWN - NLM STAT- MEDLINE DCOM- 20191104 LR - 20221207 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 8 IP - 12 DP - 2018 Dec 14 TI - 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. PG - e019572 LID - 10.1136/bmjopen-2017-019572 [doi] LID - e019572 AB - INTRODUCTION: Type 2 diabetes mellitus (T2DM) and its complications are more common among Maori and Pacific people compared with other ethnic groups in New Zealand. Comprehensive and sustained approaches that address social determinants of health are required to address this condition, including culturally specific interventions. Currently, New Zealand has no comprehensive T2DM management programme for Maori or Pacific people. METHODS AND ANALYSIS: The Mana Tu programme was developed by a Maori-led collaborative of primary healthcare workers and researchers, and codesigned with whanau (patients and their families) in order to address this gap. The programme is based in primary care and has three major components: a Network hub, Kai Manaaki (skilled case managers who work with whanau with poorly controlled diabetes) and a cross-sector network of services to whom whanau can be referred to address the wider determinants of health. The Network hub supports the delivery of the intervention through training of Kai Manaaki, referrals management, cross-sector network development and quality improvement of the programme. A two-arm cluster randomised controlled trial will be conducted to evaluate the effectiveness of the Mana Tu programme among Maori, Pacific people or those living in areas of high socioeconomic deprivation who also have poorly controlled diabetes (glycated haemoglobin, HbA1c, >65 mmol/mol (8%)), compared with being on a wait list for the programme. A total of 400 participants will be included from 10 general practices (5 practices per group, 40 participants per practice). The primary outcome is HbA1c at 12 months. Secondary outcomes include blood pressure, lipid levels, body mass index and smoking status at 12 months. This protocol outlines the proposed study design and analysis methods. ETHICS AND DISSEMINATION: Ethical approval for the trial has been obtained from the New Zealand Health and Disability Ethics Committee (17/NTB/249). Findings will be presented to practices and their patients at appropriate fora, and disseminated widely through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: ACTRN12617001276347; Pre-result. CI - (c) Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Selak, Vanessa AU - Selak V AUID- ORCID: 0000-0002-9824-8674 AD - Epidemiology & Biostatistics, University of Auckland, Auckland, New Zealand. FAU - Stewart, Tereki AU - Stewart T AD - Mana Tu, National Hauora Coalition, Auckland, New Zealand. FAU - Jiang, Yannan AU - Jiang Y AD - Department of Statistics, The University of Auckland, Auckland, New Zealand. FAU - Reid, Jennifer AU - Reid J AD - Te Kupenga Hauora Maori, University of Auckland, Auckland, New Zealand. FAU - Tane, Taria AU - Tane T AD - Mana Tu, National Hauora Coalition, Auckland, New Zealand. FAU - Carswell, Peter AU - Carswell P AD - Department of Health Systems, University of Auckland, Auckland, New Zealand. FAU - Harwood, Matire AU - Harwood M AD - Te Kupenga Hauora Maori, University of Auckland, Auckland, New Zealand. LA - eng SI - ANZCTR/ACTRN12617001276347 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20181214 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 RN - 0 (Glycated Hemoglobin A) RN - 0 (Lipids) RN - 0 (hemoglobin A1c protein, human) SB - IM MH - Adult MH - Aged MH - Allied Health Personnel/*organization & administration MH - Case-Control Studies MH - Comprehensive Health Care/*organization & administration MH - Diabetes Mellitus, Type 2/blood/diagnosis/*ethnology/therapy MH - Female MH - Follow-Up Studies MH - Glycated Hemoglobin/metabolism MH - Health Services, Indigenous/*organization & administration MH - Humans MH - Lipids/blood MH - Male MH - Middle Aged MH - New Zealand MH - Patient Care Planning/organization & administration MH - Primary Health Care/organization & administration MH - Quality Improvement/organization & administration MH - Smoking Cessation MH - Treatment Outcome PMC - PMC6303687 OTO - NOTNLM OT - clinical trials OT - general diabetes OT - primary care COIS- Competing interests: TS and TT are employees of, and MH is a contractor to, the National Hauora Coalition, a Maori-led Primary Health Organisation. The National Hauora Coalition is the recipient of a grant for the development, implementation and evaluation of the Mana Tu programme (from the Health Research Council of New Zealand, grant number 16-736). The Mana Tu programme is being implemented in the National Hauora Coalition and its associated general practices. The National Hauora Coalition will be the Network hub for the intervention and will employ the Kai Manaaki. All other authors have nothing to disclose. EDAT- 2018/12/16 06:00 MHDA- 2019/11/05 06:00 PMCR- 2018/12/14 CRDT- 2018/12/16 06:00 PHST- 2018/12/16 06:00 [entrez] PHST- 2018/12/16 06:00 [pubmed] PHST- 2019/11/05 06:00 [medline] PHST- 2018/12/14 00:00 [pmc-release] AID - bmjopen-2017-019572 [pii] AID - 10.1136/bmjopen-2017-019572 [doi] PST - epublish SO - BMJ Open. 2018 Dec 14;8(12):e019572. doi: 10.1136/bmjopen-2017-019572.