Enhancing self-care adherence in patients with heart failure: a study protocol for developing a theory-based behaviour change intervention using the COM-B behaviour model (ACHIEVE study).

INTRODUCTION: Although international guidelines recommend self-care as an integral part of routine heart failure management, and despite evidence supporting the positive outcomes related to self-care, patients are frequently unable to adhere. Self-care can be modified through behaviour change interventions (BCIs). However, previous self-care 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 reproducibility of the intervention. Thus, our aim is 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.

METHODS AND ANALYSIS: BCIs will be based on statements of findings derived through qualitative meta-summary techniques and a quantitative meta-analysis. These reviews will be used to extract factors (target behaviours) associated with self-care adherence/non-adherence. Extracted target behaviours will be mapped onto the 'Capability, Opportunity, Motivation and Behaviour' (COM-B) model to capture the underlying mechanisms involved. 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. Suggested BCIs will then be translated into locally relevant interventions using the Normalisation Process Theory to overcome the difficulties of implementing theoretically derived interventions into practice. Finally, a consensus development method will be employed to fine-tune the content and acceptability of the intervention manual to increase the likelihood of successfully piloting and implementing future BCIs into the German healthcare system.

ETHICS AND DISSEMINATION: This study has been reviewed and approved by the Ethics Committee of the Medical Faculty of the Heinrich Heine University Düsseldorf, Germany (Ref #: 2018-30). The results will be disseminated via peer-reviewed journal publications, conference presentations and stakeholder engagement activities.

TRIAL REGISTRATION NUMBER: DRKS00014855; Pre-results.