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

Gabrielle Cécile Santos; Maria Liljeroos; Kelly Tschann; Kris Denhaerynck; Justine Wicht; Corrine Y Jurgens; Roger Hullin; Petra Schäfer-Keller

doi:10.1186/s40814-023-01390-3

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

Pilot Feasibility Stud. 2023 Oct 4;9(1):168. doi: 10.1186/s40814-023-01390-3.

Authors

Gabrielle Cécile Santos^{1

2}, Maria Liljeroos^{3

4}, Kelly Tschann¹, Kris Denhaerynck⁵, Justine Wicht⁶, Corrine Y Jurgens⁷, Roger Hullin^{8

9}, Petra Schäfer-Keller¹⁰

Affiliations

¹ School of Health Sciences, HES-SO University of Applied Sciences and Arts Western Switzerland, Fribourg, Switzerland.
² Institute of Higher Education and Research in Healthcare-IUFRS, University of Lausanne, Lausanne University Hospital, Lausanne, Switzerland.
³ Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.
⁴ Centre for Clinical Research Sörmland, Uppsala University, Eskilstuna, Sweden.
⁵ Institute of Nursing Science, Department of Public Health, University of Basel, Basel, Switzerland.
⁶ Service d'Aide et de Soins à Domicile de La Sarine, Fribourg, Switzerland.
⁷ William F. Connell School of Nursing, Boston College, Chestnut Hill, Massachusetts, USA.
⁸ Department of Cardiology, Lausanne University Hospital, Lausanne, Switzerland.
⁹ Faculty of Biology and Medicine, University of Lausanne, Lausanne, Switzerland.
¹⁰ School of Health Sciences, HES-SO University of Applied Sciences and Arts Western Switzerland, Fribourg, Switzerland. petra.schaefer-keller@hefr.ch.

Abstract

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.

Keywords: Acceptability; Clinical trial; Complex intervention; Feasibility; Feasibility quasi-experimental study; Heart failure; Informal caregivers; Self-care; Symptom perception.