A multicomponent complex intervention for supportive follow-up of persons with chronic heart failure: a randomized controlled pilot study (the UTILE project).

BACKGROUND: Heart failure (HF) is a progressive disease associated with a high burden of symptoms, high morbidity and mortality, and low quality of life (QoL). This study aimed to evaluate the feasibility and potential outcomes of a novel multicomponent complex intervention, to inform a future full-scale randomized controlled trial (RCT) in Switzerland. METHODS: We conducted a pilot RCT at a secondary care hospital for people with HF hospitalized due to decompensated HF or with a history of HF decompensation over the past 6 months. We randomized 1:1; usual care for the control (CG) and intervention group (IG) who received the intervention as well as usual care. Feasibility measures included patient recruitment rate, study nurse time, study attrition, the number and duration of consultations, intervention acceptability and intervention fidelity. Patient-reported outcomes included HF-specific self-care and HF-related health status (KCCQ-12) at 3 months follow-up. Clinical outcomes were all-cause mortality, hospitalization and days spent in hospital. RESULTS: We recruited 60 persons with HF (age mean = 75.7 years, ± 8.9) over a 62-week period, requiring 1011 h of study nurse time. Recruitment rate was 46.15%; study attrition rate was 31.7%. Follow-up included 2.14 (mean, ± 0.97) visits per patient lasting a total of 166.96 min (mean, ± 72.55), and 3.1 (mean, ± 1.7) additional telephone contacts. Intervention acceptability was high. Mean intervention fidelity was 0.71. We found a 20-point difference in mean self-care management change from baseline to 3 months in favour of the IG (Cohens' d = 0.59). Small effect sizes for KCCQ-12 variables; less IG participants worsened in health status compared to CG participants. Five deaths occurred (IG = 3, CG = 2). There were 13 (IG) and 18 (CG) all-cause hospital admissions; participants spent 8.90 (median, IQR = 9.70, IG) and 15.38 (median, IQR = 18.41, CG) days in hospital. A subsequent full-scale effectiveness trial would require 304 (for a mono-centric trial) and 751 participants (for a ten-centre trial) for HF-related QoL (effect size = 0.3; power = 0.80, alpha = 0.05). CONCLUSION: We found the intervention, research methods and outcomes were feasible and acceptable. We propose increasing intervention fidelity strategies for a full-scale trial. TRIAL REGISTRATION: ISRCTN10151805 , retrospectively registered 04/10/2019.

Symptom perception in heart failure - Interventions and outcomes: A scoping review.

BACKGROUND: Symptom perception in heart failure has recently been described as essential in the self-care process bridging self-care maintenance and self-care management. Accordingly, symptom perception appears to be critical for improving patient outcomes such as decreased hospital readmission and increased survival. OBJECTIVES: To explore what interventions have been reported on heart failure symptom perception and to describe outcomes responsive to symptom perception. DESIGN: We conducted a scoping review using PRISMA Extension for Scoping Reviews. DATA SOURCES: Structured searches of Medline, PubMed, Embase, CINAHL, PsychINFO, Web of Science, Cochrane, Joanna Briggs Institute and Grey literature databases. REVIEW METHODS: Two authors independently screened references for eligibility. Eligible articles were written in English, French, German, Swedish, Italian or Spanish and concerned symptom perception in adults with heart failure. Data were extracted and charted in tables by three reviewers. Results were narratively summarized. RESULTS: We identified 99 eligible studies from 3055 references. Seven interventional studies targeted symptom perception as the single intervention component. Mixed results have been found: while some reported decreased symptom frequency, intensity and distress, enhanced health-related quality of life, improved heart failure self-care maintenance and management as well as a greater ability to mention heart failure symptoms, others found more contacts with healthcare providers or no impact on anxiety, heart failure self-care nor a number of diary reported symptoms. Additional interventional studies included symptom perception as one component of a multi-faceted intervention. Outcomes responsive to symptom perception were improved general and physical health, decreased mortality, heart failure decompensation, as hospital/emergency visits, shorter delays in seeking care, more consistent weight monitoring, improved symptom recognition as well as self-care management, decreased hospital length of stay and decreased costs. CONCLUSIONS: While many studies allowed to map a comprehensive overview of interventions supporting symptom perception in heart failure as well as responsiveness to outcomes, only a few single component intervention studies targeting symptom perception have been reported and study designs preclude assessing intervention effectiveness. With regard to multiple component interventions, the specific impact of symptom perception interventions on outcomes remains uncertain to date. Well-designed studies are needed to test the effectiveness of symptom perception interventions and to elucidate relationships with outcomes.

Symptom perception in heart failure: a scoping review on definition, factors and instruments.

BACKGROUND: Symptom perception in heart failure has been identified as crucial for effective self-care that is a modifiable factor related to decreased hospital readmission and improved survival. AIMS: To review systematically the heart failure symptom perception literature and synthesise knowledge on definition, description, factors and instruments. METHODS: We conducted a scoping review including studies reporting patient-reported symptom perception in adults with heart failure. Structured searches were conducted in Medline, PubMed, Embase, CINAHL, PsychINFO, Web of Science, Cochrane, JBI and grey literature. Two authors independently reviewed references for eligibility. Data were charted in tables and results narratively summarised. RESULTS: The search yielded 3057 references, of which 106 were included. The definition of heart failure symptom perception comprised body listening, monitoring signs, recognising, interpreting and labelling symptoms, and furthermore awareness of and assigning meaning to the change. Symptom monitoring, recognition and interpretation were identified as challenging. Symptom perception facilitators include prior heart failure hospitalisation, heart failure self-care maintenance, symptom perception confidence, illness uncertainty and social support. Barriers include knowledge deficits, symptom clusters and lack of tools/materials. Factors with inconsistent impact on symptom perception include age, sex, education, experiences of living with heart failure, comorbidities, cognitive impairment, depression and symptom progression. One instrument measuring all dimensions of heart failure symptom perception was identified. CONCLUSION: Heart failure symptom perception definition and description have been elucidated. Several factors facilitating or hampering symptom perception are known. Further research is needed to determine a risk profile for poor symptom perception - which can then be taken into consideration when supporting heart failure self-care.