Research Center for Health Policy and Economics, Hitotsubashi University, 2-1 Naka, Kunitachi, Tokyo, 186-8601, Japan.
Department of Community and Family Medicine, Fukushima Medical University, 1 Hikarigaoka, Fukushima, 960-1247, Japan.
Trials. 2023 May 8;24(1):317. doi: 10.1186/s13063-023-07345-6.
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.
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).
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.
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.
2 型糖尿病（T2DM）负担不断加重，全球医疗保健成本不断上升，因此迫切需要找到能够在 T2DM 人群中促进持续自我管理行为的干预措施，同时尽量减少医疗保健系统的成本。本研究旨在评估一种新的行为改变干预措施的效果，该干预措施旨在便于在广泛的初级保健环境中实施和推广。
这是一项为期 6 个月随访的群组随机对照试验（RCT），旨在评估 FEEDBACK 干预的效果。FEEDBACK 是一种个性化的多组分干预措施，旨在由全科医生在常规糖尿病咨询期间提供。它由五个步骤组成，旨在增强医患合作关系，激励自我管理行为：（1）使用“心脏年龄”工具沟通心血管风险，（2）设定目标，（3）制定行动计划，（4）行为契约，以及（5）反馈行为。我们计划从日本 20 个初级保健机构（群组单位）招募 264 名 T2DM 患者和血糖控制不理想的成年人，将他们随机分配到干预组或对照组。主要结局测量指标是 6 个月随访时 HbA1c 水平的变化。次要结局指标包括心血管风险评分的变化、6 个月随访时达到推荐血糖目标（HbA1c<7.0%[53mmol/mol]）的概率，以及一系列行为和心理社会变量。计划的主要分析将根据意向治疗原则在个体水平上进行。将使用混合效应模型对主要结局的组间比较进行分析。本研究方案已获得日本福岛县鹿岛医院的研究伦理委员会批准（编号：2022002）。
本文描述了一项群组 RCT 的设计，该 RCT 将评估 FEEDBACK 的效果，FEEDBACK 是一种个性化的多组分干预措施，旨在增强医患合作关系，使更多的 T2DM 成年人更有效地参与自我管理行为。
该研究方案于 2022 年 11 月 29 日在 UMIN 临床试验注册中心（UMIN-CTR ID UMIN000049643）前瞻性注册。在提交本文时，参与者的招募正在进行中。
