Enhancing self-care adherence in heart failure patients by developing a manual containing well-defined and theory-based behaviour change interventions through the application of the COM-B behaviour model

尽管国际指南建议将持续的自我护理作为常规心力衰竭管理的一部分，尽管有证据支持与自我护理相关的积极结果，但患者经常无法坚持。心衰自我护理可以通过行为改变干预（BCIs）进行修改和加强。然而，先前的自我管理干预在提高自我护理依从性方面取得的成功有限，因为它们既没有理论基础，也没有明确的定义，这就排除了对潜在因果机制的识别，以及干预的透明度和可重复性。因此，我们建议开发一份干预手册，其中包含基于理论的脑机接口，这些脑机接口使用八种描述符来定义，以标准化的方式描述脑机接口。该手册将作为一个蓝图，然后可以在随后的探索性试验中充满信心地应用，以提高患者对自我保健的坚持。为了系统地管理开发脑机接口的过程，我们的工作计划包括四个阶段。行为改变干预措施将基于我们的研究团队从最近完成的定性荟萃总结项目（HE 7352/1-1）和Kessing等人（2016）发表的定量荟萃分析结果中得出的结果的选择陈述。这两篇综合定性和定量研究的最新综合综述将用于提取与自我护理依从性/不依从性（第一阶段）相关的因素（目标行为）。患者与坚持自我保健相关的健康行为将得到加强；与不遵守相关的行为将通过教唆新的可取行为来改变。然后，与依从/不依从相关的提取行为将被映射到“能力，机会，动机和行为”（COM-B）模型中，从而捕获所涉及的潜在机制（阶段2）。为了开发改变的方法，将使用“行为改变技术分类法”，以便将目标行为有效地映射到已建立的行为改变技术上，以加强促进因素或修改阻碍因素（阶段3）。然后，建议的脑机接口将使用正常化过程理论（NPT）转化为当地相关的干预措施，以克服将理论推导的干预措施实施到日常实践中的困难。应用《不扩散核武器法》将有助于确定促进/抑制有效和持续地将干预措施纳入常规临床工作的因素。最后，将采用共识开发方法（德尔菲技术）对干预手册的内容和可接受性进行微调（第四阶段），以增加未来在德国卫生保健系统中成功试点和实施脑机接口的可能性。

Although international guidelines recommend on-going self-care as part of routine heart failure management, and despite evidence supporting the positive outcomes related to self-care, patients are frequently unable to adhere. Heart failure self-care can be modified and enhanced through behaviour change interventions (BCIs). However, previous self-management interventions have shown limited success in improving adherence to self-care because they were neither theory-based nor well defined, which precludes the identification of underlying causal mechanisms as well as transparency and reproducibility of the intervention. Thus, we propose to develop an intervention manual that contains theory-based BCIs that are well-defined using eight descriptors proposed to describe BCIs in a standardised way. The manual will serve as a blueprint, which then can be applied with confidence in a subsequent exploratory trial that seeks to enhance patients’ adherence to self-care. To manage the process of developing BCIs in a systematic fashion, our work programme consists of four stages. Behaviour change interventions will be based on both selected statements of findings that were derived by our research team from the recently completed qualitative meta-summary project (HE 7352/1-1) and findings from a quantitative meta-analysis published by Kessing et al. (2016). These two up-to-date comprehensive reviews synthesising qualitative and quantitative studies will be used to extract factors (target behaviours) associated with self-care adherence / non-adherence (Stage 1). Patients’ health behaviour associated with adherence to self-care will be reinforced; behaviour associated with non-adherence will be modified through instigating new desirable behaviour. Extracted behaviours associated with adherence/non-adherence will then be mapped onto the ‘Capability, Opportunity, Motivation and Behaviour’ (COM-B) model, thus capturing the underlying mechanisms that are involved (Stage 2). To develop approaches for change, the ‘Taxonomy of Behaviour Change Techniques’ will be used to allow effective mapping of the target behaviours onto established behaviour change techniques to either reinforce facilitating factors or to modify hindering ones (Stage 3). Suggested BCIs will then be translated into locally relevant interventions using the Normalisation Process Theory (NPT) in order to overcome the difficulties of implementing theoretically derived interventions into everyday practice. Applying NPT will assist in identifying factors that promote/inhibit the effective and sustained incorporation of interventions into routine clinical work. Finally, a consensus development method (Delphi technique) will be employed to fine-tune content and acceptability of the intervention manual (Stage 4) to increase the likelihood of successfully piloting and implementing future BCIs into the German health care system.