PMID- 37158959 OWN - NLM STAT- MEDLINE DCOM- 20230511 LR - 20230513 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 24 IP - 1 DP - 2023 May 8 TI - Fukushima study for Engaging people with type 2 Diabetes in Behaviour Associated Change (FEEDBACK): study protocol for a cluster randomised controlled trial. PG - 317 LID - 10.1186/s13063-023-07345-6 [doi] LID - 317 AB - BACKGROUND: The growing burden of type 2 diabetes mellitus (T2DM) and the rising cost of healthcare worldwide make it imperative to identify interventions that can promote sustained self-management behaviour in T2DM populations while minimising costs for healthcare systems. The present FEEDBACK study (Fukushima study for Engaging people with type 2 Diabetes in Behaviour Associated Change) aims to evaluate the effects of a novel behaviour change intervention designed to be easily implemented and scaled across a wide range of primary care settings. METHODS: A cluster randomised controlled trial (RCT) with a 6-month follow-up will be conducted to evaluate the effects of the FEEDBACK intervention. FEEDBACK is a personalised, multi-component intervention intended to be delivered by general practitioners during a routine diabetes consultation. It consists of five steps aimed at enhancing doctor-patient partnership to motivate self-management behaviour: (1) communication of cardiovascular risks using a 'heart age' tool, (2) goal setting, (3) action planning, (4) behavioural contracting, and (5) feedback on behaviour. We aim to recruit 264 adults with T2DM and suboptimal glycaemic control from 20 primary care practices in Japan (cluster units) that will be randomly assigned to either the intervention or control group. The primary outcome measure will be the change in HbA1c levels at 6-month follow-up. Secondary outcome measures include the change in cardiovascular risk score, the probability to achieve the recommended glycaemic target (HbA1c <7.0% [53mmol/mol]) at 6-month follow-up, and a range of behavioural and psychosocial variables. The planned primary analyses will be carried out at the individual level, according to the intention-to-treat principle. Between-group comparisons for the primary outcome will be analysed using mixed-effects models. This study protocol received ethical approval from the research ethics committee of Kashima Hospital, Fukushima, Japan (reference number: 2022002). DISCUSSION: This article describes the design of a cluster RCT that will evaluate the effects of FEEDBACK, a personalised, multicomponent intervention aimed at enhancing doctor-patient partnership to engage adults with T2DM more effectively in self-management behaviour. TRIAL REGISTRATION: The study protocol was prospectively registered in the UMIN Clinical Trials Registry (UMIN-CTR ID UMIN000049643 assigned on 29/11/2022). On submission of this manuscript, recruitment of participants is ongoing. CI - (c) 2023. The Author(s). FAU - Rouyard, Thomas AU - Rouyard T AUID- ORCID: 0000-0001-6412-1360 AD - Research Center for Health Policy and Economics, Hitotsubashi University, 2-1 Naka, Kunitachi, Tokyo, 186-8601, Japan. thomas.rouyard@r.hit-u.ac.jp. FAU - Endo, Mei AU - Endo M AD - Department of Community and Family Medicine, Fukushima Medical University, 1 Hikarigaoka, Fukushima, 960-1247, Japan. FAU - Nakamura, Ryota AU - Nakamura R AD - Research Center for Health Policy and Economics, Hitotsubashi University, 2-1 Naka, Kunitachi, Tokyo, 186-8601, Japan. AD - Graduate School of Economics, Hitotsubashi University, 2-1 Naka, Kunitachi, Tokyo, 186-8601, Japan. FAU - Moriyama, Michiko AU - Moriyama M AD - Division of Nursing Science, Graduate School of Biomedical and Health Sciences, Hiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima, 734-8553, Japan. FAU - Stanyon, Maham AU - Stanyon M AD - Department of Community and Family Medicine, Fukushima Medical University, 1 Hikarigaoka, Fukushima, 960-1247, Japan. FAU - Kanke, Satoshi AU - Kanke S AD - Department of Community and Family Medicine, Fukushima Medical University, 1 Hikarigaoka, Fukushima, 960-1247, Japan. FAU - Nakamura, Koki AU - Nakamura K AD - Department of Community and Family Medicine, Fukushima Medical University, 1 Hikarigaoka, Fukushima, 960-1247, Japan. FAU - Chen, Cynthia AU - Chen C AD - Saw Swee Hock School of Public Health, National University of Singapore, 12 Science Drive 2, #10-01, Singapore, 117549, Singapore. FAU - Hara, Yasushi AU - Hara Y AD - Graduate School of Economics, Hitotsubashi University, 2-1 Naka, Kunitachi, Tokyo, 186-8601, Japan. AD - Graduate School of Business Administration, Kobe University, 2-1 Rokkodaicho, Nada Ward, Kobe, Hyogo, 657-0013, Japan. FAU - Ii, Masako AU - Ii M AD - Graduate School of Economics, Hitotsubashi University, 2-1 Naka, Kunitachi, Tokyo, 186-8601, Japan. FAU - Kassai, Ryuki AU - Kassai R AD - Department of Community and Family Medicine, Fukushima Medical University, 1 Hikarigaoka, Fukushima, 960-1247, Japan. LA - eng GR - 20K18934/Japan Society for the Promotion of Science London/ PT - Clinical Trial Protocol PT - Journal Article DEP - 20230508 PL - England TA - Trials JT - Trials JID - 101263253 RN - 0 (Glycated Hemoglobin) SB - IM MH - Adult MH - Humans MH - Feedback MH - Glycated Hemoglobin MH - *Diabetes Mellitus, Type 2/diagnosis/therapy MH - Behavior Therapy MH - Communication MH - Randomized Controlled Trials as Topic PMC - PMC10169507 OTO - NOTNLM OT - Behavioural contract OT - Behavioural intervention OT - Cluster randomised trial OT - Doctor-patient communication OT - Doctor-patient relationship OT - Heart age OT - Primary care OT - Risk communication OT - Self-management OT - Type 2 diabetes COIS- The authors declare that they have no competing interests. EDAT- 2023/05/09 13:42 MHDA- 2023/05/11 06:42 PMCR- 2023/05/08 CRDT- 2023/05/09 10:52 PHST- 2023/01/26 00:00 [received] PHST- 2023/05/02 00:00 [accepted] PHST- 2023/05/11 06:42 [medline] PHST- 2023/05/09 13:42 [pubmed] PHST- 2023/05/09 10:52 [entrez] PHST- 2023/05/08 00:00 [pmc-release] AID - 10.1186/s13063-023-07345-6 [pii] AID - 7345 [pii] AID - 10.1186/s13063-023-07345-6 [doi] PST - epublish SO - Trials. 2023 May 8;24(1):317. doi: 10.1186/s13063-023-07345-6.