Design of a Multiple-Behavior Change Intervention for Supporting Self-management in Patients With Chronic Heart Failure: An Intervention Mapping Approach.

BACKGROUND: Nonadherence to medication and low physical activity contribute to morbidity, mortality, and decreased quality of life among patients with chronic heart failure (CHF). Effective interventions that can be delivered during routine clinical care are lacking. OBJECTIVE: We aimed to adapt the feasible and cost-effective Adherence Improving self-Management Strategy (AIMS) for patients with human immunodeficiency virus (HIV) to CHF treatment. Subsequently, we determined its acceptability and feasibility. METHODS: Adherence Improving self-Management Strategy is a systematic, nurse-delivered counseling intervention blended with eHealth to facilitate patient self-management. We used the intervention mapping framework to systematically adapt AIMS-HIV to AIMS-CHF, while preserving essential intervention elements. Therefore, we systematically consulted the scientific literature, patients with CHF and nurses, and pretested intervention materials. RESULTS: Adherence Improving self-Management Strategy-HIV was modified to AIMS-CHF: a multiple-behavior change intervention, focused on medication adherence and physical activity. Key self-management determinants (such as attitudes, self-efficacy, and self-regulatory skills) and organization of care (such as specialized nurses delivering AIMS) were similar for HIV and heart failure care. The AIMS protocol, as well as material content and design, was systematically adapted to CHF. Preliminary testing suggests that AIMS-CHF is likely feasible and acceptable to patients with CHF and care providers. CONCLUSION: Using the intervention mapping protocol, AIMS-HIV could be systematically adapted to AIMS-CHF and seems acceptable and feasible. Evidence from the literature, behavioral theory, and input from nurses and patients were essential in this process. Adherence Improving self-Management Strategy-CHF should now be tested for feasibility and effectiveness in routine care.

Fluid REStriction in Heart Failure vs Liberal Fluid UPtake: Rationale and Design of the Randomized FRESH-UP Study.

AIMS: It is common practice for clinicians to advise fluid restriction in patients with heart failure (HF), but data from clinical trials are lacking. Moreover, fluid restriction is associated with thirst distress and may adversely impact quality of life (QoL). To address this gap in evidence, the Fluid REStriction in Heart failure vs liberal fluid UPtake (FRESH-UP) study was initiated. METHODS: The FRESH-UP study is a randomized, controlled, open-label, multicenter trial to investigate the effects of a 3-month period of liberal fluid intake vs fluid restriction (1500 mL/day) on QoL in outpatients with chronic HF (New York Heart Association Classes II--III). The primary aim is to assess the effect on QoL after 3 months using the Overall Summary Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ). Thirst distress, as assessed by the Thirst Distress Scale for patients with HF, KCCQ Clinical Summary Score, each of the KCCQ domains and clinically meaningful changes in these scores, the EQ-5D-5L, patient-reported fluid intake and safety (ie, death, HF hospitalizations) are secondary outcomes. The FRESH-UP study is registered at ClinicalTrials.gov (NCT04551729). CONCLUSION: The results of the FRESH-UP study will add substantially to the level of evidence concerning fluid management in chronic HF and may impact the QoL of these patients.