Feasibility, acceptability, and outcome responsiveness of the SYMPERHEART intervention to support symptom perception in persons with heart failure and their informal caregivers: a feasibility quasi-experimental study.

BACKGROUND: Symptom perception is an important process of heart failure (HF) self-care that persons with HF need in order to master self-care management. It also leads to better patient outcomes. Symptom perception consists of body observation and analysis, which are both challenging. We aimed to test the feasibility, acceptability, and outcome responsiveness of a novel intervention (SYMPERHEART) delivered to persons with HF with their informal caregiver. METHODS: We designed SYMPERHEART as a complex evidence-informed education and support intervention targeting body observation and analysis. We conducted a feasibility quasi-experimental study with a single group pre-post-test design. We included three subsamples: persons with HF receiving home-based care, their informal caregivers exposed to SYMPERHEART, and home-care nurses who delivered SYMPERHEART during 1 month. We assessed feasibility by recruitment time, time to deliver SYMPERHEART, eligibility rate, and intervention fidelity. We assessed acceptability by consent rate, retention rate, persons with HF engagement in body observation, and treatment acceptability. Outcome responsiveness was informed by patient-reported (PRO) and clinical outcomes: HF self-care and the informal caregivers' contribution to HF self-care, perception of HF symptom burden, health status, caregivers' burden, and HF events. We performed descriptive analyses for quantitative data and calculated Cohen's d for PROs. A power analysis estimated the sample size for a future full-scale effectiveness study. RESULTS: We included 18 persons with HF, 7 informal caregivers, and 9 nurses. Recruitment time was 112.6 h. The median time to deliver SYMPERHEART for each participant was 177.5 min. Eligibility rate was 55% in persons with HF. Intervention fidelity revealed that 16 persons with HF were exposed to body observation and analysis. Consent and retention rates in persons with HF were 37.5% and 100%, respectively. Participants engaged actively in symptom and weight monitoring. Treatment acceptability scores were high. Symptom perception and informal caregivers' contribution to symptom perception were found to be responsive to SYMPERHEART. We estimate that a sample size of 50 persons with HF would be needed for a full-scale effectiveness study. CONCLUSIONS: SYMPERHEART was found to be feasible and acceptable. This feasibility study provides information for a subsequent effectiveness study. TRIAL REGISTRATION: ISRCTN. ISRCTN18151041 , retrospectively registered on 4 February 2021, ICTRP Search Portal.