SYMPERHEART: an intervention to support symptom perception in persons with heart failure and their informal caregiver: a feasibility quasi-experimental study protocol

Abstract

IntroductionSymptom perception in heart failure (HF) has been identified as crucial for effective self-care, and is related to patient and health system outcomes. There is uncertainty regarding the feasibility and acceptability of symptom perception support and doubts regarding how to include informal caregivers. This study aims to test the feasibility, acceptability and outcome responsiveness of an intervention supporting symptom perception in persons with HF and their informal caregiver.Methods and analysisA feasibility study with a quasi-experimental pretest and post-test single group design is conducted. The convenience sample consists of 30 persons with HF, their informal caregivers and six nurses. SYMPERHEART is an evidence-informed intervention that targets symptom perception by educational and support components. Feasibility is measured by time-to-recruit; time-to-deliver; eligibility rate; intervention delivery fidelity rate. Acceptability is measured by rate of consent, retention rate, treatment acceptability and the engagement in the intervention components. Outcome responsiveness includes: HF self-care (via the Self-care of Heart Failure Index V.7.2); perception of HF symptom burden (via the Heart Failure Somatic Perception Scale V.3); health status (via the Kansas City Cardiomyopathy Questionnaire-12); caregivers’ contribution to HF self-care (via the Caregiver Contribution to Self-Care of Heart Failure Index 2); caregivers’ burden (via the Zarit Burden Interview). Clinical outcomes include HF events, hospitalisation reason and length of hospital stay. Descriptive statistics will be used to report feasibility, acceptability, patient-reported outcomes (PRO) and clinical outcomes. PRO and caregiver-reported outcome responsiveness will be reported with mean absolute change and effect sizes.Ethics and disseminationThe study is conducted according to the Declaration of Helsinki. The Human Research Ethics Committee of the Canton of Vaud, Switzerland, has approved the study. Written informed consent from persons with HF and informal caregivers are obtained. Results will be published via peer reviewed and professional journals, and further disseminated via congresses.Trial registration numberISRCTN18151041.

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

“…Three interlocking convenience samples composed the study sample. We targeted (a) 15 to 30 adults with confirmed HF, in New York Heart Association (NYHA) functional classes II–IV, receiving home-based care and living at home; (b) their informal adult caregiver who has at least one weekly contact; and (c) home-care nurses working in the study setting and trained to deliver SYMPERHEART [ 16 ]. The target sample size of 15 to 30 persons with HF was considered appropriate for a feasibility study [ 25 – 30 ] to inform intervention feasibility and acceptability, which was the study’s primary aim.…”

“…Why, intervention rationale, theory, or goal SYMPERHEART is a complex evidence-based intervention targeting both body observation and body analysis to support and educate persons with HF and their informal caregivers to monitor, recognize and interpret their HF symptoms, in order to guide symptom response Based on the situation-specific theory of HF self-care [ 8 ], symptom perception is a needed step to attain self-care management in the process of HF self-care. Based on evidence synthesis on symptom perception in HF [ 9 , 10 ] and on care needs [ 31 ], the SYMPERHEART intervention was detailed [ 16 ] to be tested in the local setting 3. What, materials Materials used to prepare the intervention delivery: • Patient-reported outcomes to identify HF self-care [ 32 ] and symptom burden [ 33 ] in persons with HF • Informal caregivers-reported outcomes to identify contribution to HF self-care [ 34 ] and caregiver burden [ 35 ] in informal caregivers of persons with HF Materials used to deliver the intervention to participants: • HF booklet of the Swiss Heart Foundation [ 36 ] • Paper graphs for daily symptom monitoring [ 13 ] • Digital weighing scale • Guided reflection questions [ 16 ] • Heartfailurematters.org web site Materials used to train the nurses delivering the intervention: • An intervention manual detailing how the intervention components are operationalized • A training manual detailing the learning objectives and the resources used during the teaching 4.…”

“…Based on evidence synthesis on symptom perception in HF [ 9 , 10 ] and on care needs [ 31 ], the SYMPERHEART intervention was detailed [ 16 ] to be tested in the local setting 3. What, materials Materials used to prepare the intervention delivery: • Patient-reported outcomes to identify HF self-care [ 32 ] and symptom burden [ 33 ] in persons with HF • Informal caregivers-reported outcomes to identify contribution to HF self-care [ 34 ] and caregiver burden [ 35 ] in informal caregivers of persons with HF Materials used to deliver the intervention to participants: • HF booklet of the Swiss Heart Foundation [ 36 ] • Paper graphs for daily symptom monitoring [ 13 ] • Digital weighing scale • Guided reflection questions [ 16 ] • Heartfailurematters.org web site Materials used to train the nurses delivering the intervention: • An intervention manual detailing how the intervention components are operationalized • A training manual detailing the learning objectives and the resources used during the teaching 4. What, procedures, and support activities The SYMPERHEART intervention is composed of three intervention components to be delivered to persons with HF and their informal caregivers [ 16 ]: 1.…”

“…What, materials Materials used to prepare the intervention delivery: • Patient-reported outcomes to identify HF self-care [ 32 ] and symptom burden [ 33 ] in persons with HF • Informal caregivers-reported outcomes to identify contribution to HF self-care [ 34 ] and caregiver burden [ 35 ] in informal caregivers of persons with HF Materials used to deliver the intervention to participants: • HF booklet of the Swiss Heart Foundation [ 36 ] • Paper graphs for daily symptom monitoring [ 13 ] • Digital weighing scale • Guided reflection questions [ 16 ] • Heartfailurematters.org web site Materials used to train the nurses delivering the intervention: • An intervention manual detailing how the intervention components are operationalized • A training manual detailing the learning objectives and the resources used during the teaching 4. What, procedures, and support activities The SYMPERHEART intervention is composed of three intervention components to be delivered to persons with HF and their informal caregivers [ 16 ]: 1. Intervention prerequisite : the nurse identifies symptom perception barriers and facilitators [ 10 ], identifies HF self-care behaviors and individual symptom clusters based on patient-reported outcomes, discusses with the person with HF’s their main concerns related to HF, and supports self-care maintenance in discussion with the person using the HF booklet [ 36 ].…”

“…Also, symptom perception behaviors were associated with improved HF self-care and health status, as well as decreased use of health care [ 9 ]. The impact of specifically targeting symptom perception needs to be further studied [ 16 ]. Home visits by nurses within multidisciplinary follow-up of chronic HF were reported to reduce mortality and HF hospitalization [ 3 , 17 ].…”