A framework for monitoring intervention fidelity: The NOURISH trial

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-10-04 DOI:10.1016/j.cct.2025.108104

Jennifer Ventrelle , Beth Lukaszewicz , Megan Claysen , Bhayva Setia , Neelum T. Aggarwal , Christy C. Tangney , for the NOURISH Study Team

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引用次数: 0

Abstract

Background

Nutrition can have a profound impact on chronic disease outcomes, but without periodic assessment of treatment fidelity, one cannot know whether the outcomes are due to an effective intervention or other unknown factors. Repeated measurement of fidelity of all treatments and across all interventionists will ensure the likelihood that treatment differences are maintained for the duration of the trial. This paper summarizes our efforts to assess treatment fidelity throughout the ongoing Phase III dietary intervention trial known as Nutrition effects on Brain Outcomes and Recovery in Stroke after Hospitalization (NOURISH), which tests whether acute stroke survivors' adoption of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet will slow annual cognitive decline compared to those assigned to receive enhanced usual care.

Methods

Templates and measures for treatment fidelity were developed according to five key components of treatment fidelity for the NOURISH trial: (1) intervention design and protocol, (2) training of interventionists, (3) treatment delivery (includes content and process), (4) treatment receipt, and (5) treatment enactment.

Results

Through periodic assessments of such measures, investigators ensured that the interventionists were delivering the intervention consistently according to protocol and learning what the participant understood and was willing to adopt. Moreover, the intervention was further refined to make it more responsive to the needs of the diverse participants during their stroke recovery.

Conclusions

The future success of disseminating and implementing public health programming for stroke recovery relies on finding the right balance between maintaining intervention fidelity and allowing for adaptability.

NCT 04337255.

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监测干预保真度的框架：滋养试验。

背景：营养可以对慢性疾病的结局产生深远的影响，但如果没有对治疗保真度的定期评估，人们无法知道结局是由于有效的干预还是其他未知因素。重复测量所有治疗和所有干预者的保真度将确保在试验期间维持治疗差异的可能性。本文总结了我们在正在进行的III期饮食干预试验中评估治疗忠实度的努力，该试验被称为营养对脑结局和住院后卒中恢复的影响（营养），该试验测试了急性卒中幸存者采用地中海- dash干预神经退行性延迟（MIND）饮食与接受强化常规护理的患者相比，是否会减缓年度认知衰退。方法：根据滋养试验治疗保真度的五个关键组成部分制定治疗保真度的模板和措施：(1)干预设计和方案，(2)干预人员的培训，(3)治疗交付（包括内容和过程），(4)治疗接收，(5)治疗制定。结果：通过对这些措施的定期评估，调查人员确保干预者始终如一地按照协议提供干预措施，并了解参与者理解和愿意采用的内容。此外，干预措施进一步完善，使其更符合不同参与者在中风恢复期间的需求。结论：未来成功地传播和实施卒中恢复公共卫生规划依赖于在保持干预保真度和允许适应性之间找到适当的平衡。NCT04337255。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.