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临床试验/NCT05915455
NCT05915455已完成不适用

Face and Content Validation of a Healthcare Professional-facing Toolkit to Communicate Information on the Portfolio Diet and PortfolioDiet.app

University of Toronto2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
2
主要终点
Face Validation

研究概览

简要总结

There is limited support in primary care for diet and lifestyle, the cornerstones for therapy in clinical practice guidelines. Canadian dietitian services are not covered by provincial health plans and most physicians cite a lack of education, tools and time to counsel on nutrition. To engage healthcare professionals (HCP) and patients in the delivery of nutrition interventions, the investigators have developed the Portfolio Diet mobile application, as a direct translation of clinical practice guidelines for cardiovascular and diabetes risk reduction which recommend the Portfolio Diet, a plant-based dietary pattern of cholesterol-lowering foods. To increase confidence and comfortability in advising patients on the Portfolio Diet, the investigators have developed an HCP-facing toolkit (infographic and video) to communicate information on the Portfolio Diet and Portfolio Diet mobile application. To ensure validity of these resources, the investigators will conduct face and content validation of the HCP-facing toolkit and assess whether it increases HCP knowledge and potential use in practice, and assess HCP perspectives on the Portfolio Diet mobile application.

详细描述

Background:

As the Canadian population ages, there is an increased risk of cardiovascular disease (CVD) and higher healthcare costs. Thus, there is a need for dietary approaches to target these challenges. Furthermore, with the transition to greater virtual care, innovative technology-based interventions using mobile applications provide an opportunity to engage healthcare professionals (HCP), including family physicians, registered dietitians (RDs), nurses, pharmacists, and patients in delivering nutrition care to save time, provide education, and reduce costs. The Portfolio Diet, an evidence-based therapeutic dietary pattern for CVD risk reduction, is uniquely positioned to test this innovative paradigm. This plant-based dietary pattern of five cholesterol-lowering foods (nuts, legumes, viscous fibre, plant sterols, monounsaturated fat) has been shown to result in the same low-density lipoprotein-cholesterol (LDL-C) and C-reactive protein reductions (CRP) (~30%) as statin therapy in a head-to-head randomized controlled trial. A recent systematic review and meta-analysis. confirmed these effects and showed benefits on other cardiovascular risk factors including non-high-density lipoprotein-cholesterol (non-HDL-C), apoB, triglycerides, and blood pressure. Prospective cohort studies have also shown that the Portfolio Diet is associated with a lower risk of CVD, particularly coronary heart disease, and type 2 diabetes. These benefits have led to widespread recognition of the Portfolio Diet from major international clinical practice guidelines, including the Canadian Cardiovascular Society (CCS). The investigators recently developed the Portfolio Diet mobile application, as a transformative digitally-enabled health service tool for the translation of current CCS guidelines to manage dyslipidemia and prevent CVD.

While the Portfolio Diet is recognized by clinical practice guidelines as a preventive nutrition therapy for CVD, many HCPs remain unaware of the Portfolio Diet and of the Portfolio Diet mobile application. To increase confidence and comfortability in advising patients on the Portfolio Diet, the investigators developed an HCP-facing toolkit (infographic and video) to communicate information on the Portfolio diet and Portfolio Diet app. To ensure validity, the investigators plan to conduct face and content validation of the HCP-facing toolkit and assess whether it increases HCP knowledge and potential use in practice, as well as to assess HCP perspectives of the Portfolio Diet app.

Objectives:

The primary objective is to face and content validate the HCP-facing toolkit and assess whether it increases HCP knowledge and potential use in practice. The second objective is to conduct a quality improvement assessment of the Portfolio Diet mobile application to evaluate its usability, acceptability, knowledge acquisition, quality, and potential use in practice.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Eligible participants are healthcare professionals that are registered with a regulatory college, including physicians, RDs, pharmacists and nurses.

排除标准

  • 未提供

结局指标

主要结局

Face Validation

时间窗: 30 minutes

Face validity will be determined if \<30% of respondents rating questions in parts B or C as either 1 or 2 (out of 5).

Content Validation

时间窗: 30 minutes

Content validity will be determined if \<30% of respondents rating questions in part A of the phase 1 questionnaire as irrelevant.

Usability using the System Usability Scale

时间窗: 8 days

Usability will be determined using the System Usability Scale which ranges from 0 to 100 based on responses to 10 questions. An average System Usability Scale score of \>70 indicates the tool being assessed is considered usable.

Usability using the mHealth App Usability Questionnaire

时间窗: 8 days

Usability will be determined using the standalone, HCP-facing MAUQ which includes 18 statements rated on a 7-point Likert scale. The total score will be calculated and an average score of the responses to all statements will be determined, with higher average scores indicating higher app usability.

Quality using the Mobile Application Rating Scale

时间窗: 8 days

Quality of the Portfolio Diet app will be determined using the Mobile Application Rating Scale (MARS) which comprises a 19-item objective evaluation across four domains: engagement, functionality, aesthetics, and information. The MARS also includes a 4-item subjective quality assessment, and a specific 6-item section tailored to the app being evaluated, all of which are rated on a 5-point Likert scale specific to each statement.

Knowledge Acquisition about the Portfolio Diet

时间窗: 8 days

A composite of 4 multiple-choice questions will be used to assess knowledge acquisition.

Engagement with the Portfolio Diet App

时间窗: 8 days

A composite of 11 open-ended and likert scale questions will be used to assess engagement with the app.

Acceptability of the Portfolio Diet App

时间窗: 8 days

A composite of 4 multiple-choice and open-ended questions will be used to assess acceptability of the portfolio diet and the app in specific patient populations.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laura Chiavaroli

Prinicipal Investigator

University of Toronto

研究点 (2)

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