School of Health Sciences Fribourg, HES-SO University of Applied Sciences and Arts Western Switzerland, Fribourg, Switzerland
Institute of Higher Education and Research in Healthcare, University of Lausanne Faculty of Biology and Medicine, Lausanne, Switzerland.
BMJ Open. 2021 Jul 27;11(7):e052208. doi: 10.1136/bmjopen-2021-052208.
Symptom 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.
A 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.
The 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.
ISRCTN18151041.
心力衰竭（HF）患者的症状感知能力已被确定为有效自我护理的关键，且与患者和医疗系统的结局相关。目前，针对症状感知支持的可行性和可接受性仍存在不确定性，同时对于如何纳入非专业照护者也存在疑问。本研究旨在测试一种支持 HF 患者及其非专业照护者症状感知的干预措施的可行性、可接受性和结果反应性。
本研究采用准实验性前后测单组设计进行可行性研究。方便样本包括 30 名 HF 患者、他们的非专业照护者和 6 名护士。SYMPERHEART 是一种基于证据的干预措施，通过教育和支持组件来针对症状感知。可行性通过招募时间、干预实施时间、合格率、干预实施保真度来衡量。可接受性通过同意率、保留率、治疗接受度和对干预措施的参与度来衡量。结果反应性包括：HF 自我护理（通过心力衰竭自我护理指数 V.7.2 进行评估）；HF 症状负担感知（通过心力衰竭躯体感知量表 V.3 进行评估）；健康状况（通过堪萨斯城心肌病问卷-12 进行评估）；非专业照护者对 HF 自我护理的贡献（通过心力衰竭自我护理指数 2 的非专业照护者贡献量表进行评估）；非专业照护者负担（通过照顾者负担量表进行评估）。临床结局包括 HF 事件、住院原因和住院时间。将使用描述性统计来报告可行性、可接受性、患者报告的结局（PRO）和临床结局。PRO 和照顾者报告的反应性将通过平均绝对变化和效应大小来报告。
本研究按照《赫尔辛基宣言》进行。瑞士沃州人类研究伦理委员会已批准该研究。HF 患者和非专业照护者均获得书面知情同意。研究结果将发表在同行评议和专业期刊上，并通过会议进一步传播。
ISRCTN82434567。
