早期远程姑息治疗干预对改善伊朗心力衰竭患者生活质量的可行性和可接受性：一项随机对照试验方案

The feasibility and acceptability of an early tele-palliative care intervention to improve quality of life in heart failure patients in Iran: A protocol for a randomized controlled trial.

作者信息

Mirshahi Arvin, Ghiasvandian Shahrzad, Khoshavi Meysam, Riahi Seyed Mohammad, Khanipour-Kencha Ali, Bakitas Marie, Dionne-Odom J Nicholas, Wells Rachel, Zakerimoghadam Masoumeh

机构信息

Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.

USERN Care (TUMS) Office, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Contemp Clin Trials Commun. 2023 Mar 20;33:101114. doi: 10.1016/j.conctc.2023.101114. eCollection 2023 Jun.

DOI:10.1016/j.conctc.2023.101114

PMID:36993787

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10041464/

Abstract

BACKGROUND

Heart failure (HF) has become a global health problem that has affected the quality of life of millions of people. One approach to improving patients' quality of life (QoL) with chronic diseases such as HF is palliative care. In Iran, the bulk of palliative care research is directed to patients with cancer, with the primary focus on the physical aspect rather than the psychosocial and spiritual aspects of palliative care. To address this gap, this study aims to determine the feasibility and acceptability of this early tele-palliative care intervention to improve quality of life in heart failure patients in Iran.

METHODS

The early tele-palliative care versus usual care study is designed as a single-centre, randomised, feasibility trial of 50 patients with heart failure aged 18 to 65 and clinician-determined New York Heart Association class II/III or American College of Cardiology stage B/C HF, recruited in Imam Khomeini Hospital Complex, Tehran, Iran. This intervention contains 6 weekly educational webinars and concurrent WhatsApp® group activities. Program feasibility and acceptability will be assessed by measuring the recruitment, attrition, and questionnaire completion rates; satisfaction and attitudes about the intervention will be measured via a telephone-based interviews. Secondary outcomes of Qol, mood status and number of emergency department visits will be measured with validated instruments. Participants in both groups will be followed up for 6 weeks, and the measures will be re-administered. Appropriate statistical tests will be used to analyse the data.

CONCLUSION

This is the first early tele-palliative care intervention designed for heart failure patients in Iran. The intervention has been developed by a multidisciplinary team of academic and clinical professionals with patient stakeholder input to create a rigorous and culturally responsive approach for palliative care delivery for heart failure patients in Iran.

TRIAL REGISTRATION

IRCT registration number - IRCT20100725004443N29.

摘要

背景

心力衰竭（HF）已成为一个全球性的健康问题，影响着数百万人的生活质量。姑息治疗是改善诸如HF等慢性病患者生活质量（QoL）的一种方法。在伊朗，大部分姑息治疗研究针对癌症患者，主要关注姑息治疗的身体方面，而非心理社会和精神方面。为填补这一空白，本研究旨在确定这种早期远程姑息治疗干预措施在改善伊朗心力衰竭患者生活质量方面的可行性和可接受性。

方法

早期远程姑息治疗与常规护理研究设计为一项单中心、随机、可行性试验，纳入50例年龄在18至65岁之间、临床医生判定为纽约心脏协会II/III级或美国心脏病学会B/C期HF的心力衰竭患者，在伊朗德黑兰伊玛目霍梅尼医院综合院区招募。该干预包括6次每周一次的教育网络研讨会以及同步的WhatsApp®群组活动。将通过测量招募率、损耗率和问卷完成率来评估项目的可行性和可接受性；将通过电话访谈来测量对干预措施的满意度和态度。生活质量、情绪状态和急诊就诊次数等次要结局将使用经过验证的工具进行测量。两组参与者将随访6周，并重新进行测量。将使用适当的统计检验来分析数据。