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治疗的一部分，尽管有证据支持与自我护理相关的积极结果，但患者往往无法坚持。心力衰竭自我护理可以通过行为改变干预(BCI)得到改善和加强。然而，以前的自我管理干预措施在改善对自我护理的遵守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，这排除了确定潜在的因果机制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BCI，这些BCI是使用八个建议以标准化方式描述BCI的描述符来明确定义的。该手册将作为一份蓝图，然后可以自信地应用于随后的探索性试验，旨在提高患者对自我护理的坚持。为了有系统地管理发展BCI的进程，我们的工作方案包括四个阶段。行为改变干预将基于我们的研究团队从最近完成的定性元总结项目(HE 7352/1-1)中获得的精选研究结果陈述，以及凯辛等人发表的定量元分析研究结果。(2016)。这两个最新的全面审查综合了定性和定量研究，将用于提取与自我护理遵守/不遵守(阶段1)相关的因素(目标行为)。患者与坚持自我护理相关的健康行为将得到加强；与不遵守相关的行为将通过鼓励新的令人满意的行为来改变。然后，提取的与遵守/不遵守相关的行为将被映射到“能力、机会、动机和行为”(COM-B)模型，从而捕获所涉及的潜在机制(阶段2)。为了发展改变的方法，将使用“行为改变技术分类”，以便有效地将目标行为映射到既定的行为改变技术，以加强促进因素或改变阻碍因素(阶段3)。然后，建议的BCI将利用正常化进程理论(NPT)转化为与当地相关的干预措施，以克服将理论上得出的干预措施落实到日常实践中的困难。应用《不扩散核武器条约》将有助于查明促进/抑制将干预措施有效和持续地纳入常规临床工作的因素。最后，将使用共识开发方法(Delphi技术)来微调干预手册(阶段4)的内容和可接受性，以增加成功地将未来的BCI试点和实施到德国医疗保健系统中的可能性。

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.