一项针对慢性心力衰竭患者支持性随访的多组分综合干预措施：一项随机对照试验性研究（UTILE项目）

A multicomponent complex intervention for supportive follow-up of persons with chronic heart failure: a randomized controlled pilot study (the UTILE project).

作者信息

Schäfer-Keller Petra, Graf Denis, Denhaerynck Kris, Santos Gabrielle Cécile, Girard Josepha, Verga Marie-Elise, Tschann Kelly, Menoud Grégoire, Kaufmann Anne-Laure, Leventhal Marcia, Richards David A, Strömberg Anna

机构信息

Institute of Applied Research in Health, School of Health Sciences Fribourg, HES-SO University of Applied Sciences and Arts Western Switzerland, Fribourg, Switzerland.

Cardiology, HFR Fribourg - Hôpital Cantonal, Fribourg, Switzerland.

出版信息

Pilot Feasibility Stud. 2023 Jun 27;9(1):106. doi: 10.1186/s40814-023-01338-7.

DOI:10.1186/s40814-023-01338-7

PMID:37370176

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10294419/

Abstract

BACKGROUND

Heart failure (HF) is a progressive disease associated with a high burden of symptoms, high morbidity and mortality, and low quality of life (QoL). This study aimed to evaluate the feasibility and potential outcomes of a novel multicomponent complex intervention, to inform a future full-scale randomized controlled trial (RCT) in Switzerland.

METHODS

We conducted a pilot RCT at a secondary care hospital for people with HF hospitalized due to decompensated HF or with a history of HF decompensation over the past 6 months. We randomized 1:1; usual care for the control (CG) and intervention group (IG) who received the intervention as well as usual care. Feasibility measures included patient recruitment rate, study nurse time, study attrition, the number and duration of consultations, intervention acceptability and intervention fidelity. Patient-reported outcomes included HF-specific self-care and HF-related health status (KCCQ-12) at 3 months follow-up. Clinical outcomes were all-cause mortality, hospitalization and days spent in hospital.

RESULTS

We recruited 60 persons with HF (age mean = 75.7 years, ± 8.9) over a 62-week period, requiring 1011 h of study nurse time. Recruitment rate was 46.15%; study attrition rate was 31.7%. Follow-up included 2.14 (mean, ± 0.97) visits per patient lasting a total of 166.96 min (mean, ± 72.55), and 3.1 (mean, ± 1.7) additional telephone contacts. Intervention acceptability was high. Mean intervention fidelity was 0.71. We found a 20-point difference in mean self-care management change from baseline to 3 months in favour of the IG (Cohens' d = 0.59). Small effect sizes for KCCQ-12 variables; less IG participants worsened in health status compared to CG participants. Five deaths occurred (IG = 3, CG = 2). There were 13 (IG) and 18 (CG) all-cause hospital admissions; participants spent 8.90 (median, IQR = 9.70, IG) and 15.38 (median, IQR = 18.41, CG) days in hospital. A subsequent full-scale effectiveness trial would require 304 (for a mono-centric trial) and 751 participants (for a ten-centre trial) for HF-related QoL (effect size = 0.3; power = 0.80, alpha = 0.05).

CONCLUSION

We found the intervention, research methods and outcomes were feasible and acceptable. We propose increasing intervention fidelity strategies for a full-scale trial.

TRIAL REGISTRATION

ISRCTN10151805 , retrospectively registered 04/10/2019.

摘要

背景

心力衰竭（HF）是一种进行性疾病，伴有高症状负担、高发病率和死亡率以及低生活质量（QoL）。本研究旨在评估一种新型多组分综合干预措施的可行性和潜在效果，为瑞士未来的大规模随机对照试验（RCT）提供参考。

方法

我们在一家二级护理医院进行了一项试点随机对照试验，对象为因失代偿性心力衰竭住院或在过去6个月内有心力衰竭失代偿病史的心力衰竭患者。我们按1:1随机分组；对照组（CG）接受常规护理，干预组（IG）接受干预措施以及常规护理。可行性指标包括患者招募率、研究护士时间、研究损耗率、咨询次数和时长、干预措施的可接受性和干预保真度。患者报告的结局包括3个月随访时特定于心力衰竭的自我护理情况和与心力衰竭相关的健康状况（KCCQ-12）。临床结局为全因死亡率、住院率和住院天数。

结果

在62周的时间里，我们招募了60例心力衰竭患者（平均年龄=75.7岁，±8.9），研究护士花费了1011小时。招募率为46.15%；研究损耗率为31.7%。随访包括每位患者平均2.14次（±0.97）就诊，总时长为166.96分钟（±72.55），以及平均3.1次（±1.7）额外的电话联系。干预措施的可接受性较高。平均干预保真度为0.71。我们发现，从基线到3个月，干预组在自我护理管理方面的平均变化比对照组高20分（科恩d值=0.59）。KCCQ-12变量的效应量较小；与对照组参与者相比，干预组中健康状况恶化的参与者较少。发生了5例死亡（干预组=3例，对照组=2例）。全因住院次数干预组为第13次，对照组为第18次；干预组参与者住院天数中位数为8.90天（IQR=9.70），对照组为15.38天（IQR=18.41）。后续的大规模有效性试验若要评估与心力衰竭相关的生活质量，对于单中心试验需要304名参与者，对于十中心试验需要751名参与者（效应量=0.3；检验效能=0.80，α=0.05）。