Fukushima study for Engaging people with type 2 Diabetes in Behaviour Associated Change (FEEDBACK): study protocol for a cluster randomised controlled trial

Trials

Study Protocol

Maham Stanyon¹  Ryuki Kassai¹  Koki Nakamura¹  Mei Endo¹  Satoshi Kanke¹  Michiko Moriyama²  Masako Ii³  Yasushi Hara⁴  Thomas Rouyard⁵  Ryota Nakamura⁶  Cynthia Chen⁷ 

[1] Department of Community and Family Medicine, Fukushima Medical University, 1 Hikarigaoka, 960-1247, Fukushima, Japan;Division of Nursing Science, Graduate School of Biomedical and Health Sciences, Hiroshima University, 1-2-3 Kasumi, Minami-ku, 734-8553, Hiroshima City, Hiroshima, Japan;Graduate School of Economics, Hitotsubashi University, 2-1 Naka, 186-8601, Kunitachi, Tokyo, Japan;Graduate School of Economics, Hitotsubashi University, 2-1 Naka, 186-8601, Kunitachi, Tokyo, Japan;Graduate School of Business Administration, Kobe University, 2-1 Rokkōdaichō, Nada Ward, 657-0013, Kobe, Hyogo, Japan;Research Center for Health Policy and Economics, Hitotsubashi University, 2-1 Naka, 186-8601, Kunitachi, Tokyo, Japan;Research Center for Health Policy and Economics, Hitotsubashi University, 2-1 Naka, 186-8601, Kunitachi, Tokyo, Japan;Graduate School of Economics, Hitotsubashi University, 2-1 Naka, 186-8601, Kunitachi, Tokyo, Japan;Saw Swee Hock School of Public Health, National University of Singapore, 12 Science Drive 2, #10-01, 117549, Singapore, Singapore;

关键词: Type 2 diabetes;    Self-management;    Behavioural intervention;    Risk communication;    Heart age;    Doctor-patient relationship;    Doctor-patient communication;    Behavioural contract;    Primary care;    Cluster randomised trial;   

DOI  :  10.1186/s13063-023-07345-6

 received in 2023-01-26, accepted in 2023-05-02,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsA 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).DiscussionThis 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 registrationThe 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.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

Fig. 2

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