HCP-facing Portfolio Diet Toolkit Validation Study

December 3, 2024 updated by: Laura Chiavaroli, University of Toronto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Design: We aim to recruit 65 physicians, registered dietitians, and other allied HCP from clinics for a 2-phase study to assess face and content validation of the HCP-facing toolkit and usability of the Portfolio Diet mobile application. In phase 1, 15 HCP with receive the toolkit and a feedback questionnaire. In phase 2, 10 HCPs from phase 1 will be invited to create an account on the Portfolio Diet mobile application and use it daily for 5-minutes over 7-days. On Day 8, a mixed-form questionnaire will be used to evaluate acceptability, knowledge acquisition, engagement, usability using the System Usability Scale (SUS) and the mHealth App Usability Questionnaire (MAUQ), and potential use in practice. After the first round, data will be compiled and reviewed to assess if revisions should be made. Based on the results from the first round, either the original or the revised versions will be presented in the second round to 50 HCP following a similar assessment method as per round 1 but in addition to the SUS and MAUQ, the mixed-form questionnaire will include the Mobile Application Rating Scale (MARS) to assess the quality of the app. This sample size in round 2 was selected to enhance external validity and ensure a representative sample of HCPs, aiding in the validation of the MARS.

Outcomes: The primary outcomes are face and content validation of the HCP-facing toolkit resources. The secondary outcomes are usability, acceptability, knowledge acquisition, engagement, potential use in practice, and the quality of the Portfolio Diet app.

Data analyses: The Phase I feedback questionnaire for the HCP-facing Portfolio diet infographic and video consists of part A to assess content validity of the infographic and parts B and C to assess face validity of the infographic and video, respectively. In part A, the infographic has been divided into 6 parts, which HCP will be asked to rate individually on a scale of one to four with regard to its relevance. In parts B and C, HCP will be asked to rate a series of statements assessing content validity on a scale of 1-5, with 1 being "strongly disagree" and 5 being "strongly agree" for the infographic and video, respectively. After the first round, data will be compiled and reviewed with the study team. Lynn's method will be used to assess content validity of the HCP-facing infographic and video. If more than 30% of respondents rate any question in part A as irrelevant or rate 1-2 for any question in parts B or C, revisions will be made to the HCP-facing Portfolio diet toolkit resources as applicable. The second round of HCP will be presented either the original version or, if >30% rate the resources poorly, the revised version of the toolkit resources will be used and the HCP asked to follow the same method of assessing face and content validity.

In Phase 2, after 7-days of using the Portfolio Diet app, a mixed-form questionnaire will be used to evaluate the acceptability, knowledge acquisition, engagement with the app, usability using the SUS and the MAUQ, and potential use in practice. The SUS is a validated usability questionnaire used in clinical settings to assess the usability of various systems and tools. The SUS includes 10 statements on a 5-point Likert scale, which is a psychometric scale frequently applied in health, and nutrition research, as well as in quality improvement testing, to assess the acceptability of systems and tools. The MAUQ is a recently developed questionnaire that focuses specifically on the usability of mobile health apps. It offers four versions catering to different app types (interactive or standalone) and target app users (patient or HCP), with the HCP-facing versions not yet validated. As such, data will be collected on the standalone HCP-facing version of the MAUQ in addition to the widely used SUS to contribute to validation. The SUS includes 10 statements rated on a 5-point Likert scale. The standalone, HCP-facing MAUQ includes 18 statements rated on a 7-point Likert scale. After the first round, data will be compiled and reviewed with the study team. If the calculated SUS is <70 or more than 30% of respondents indicate serious concerns, revisions will be made to the Portfolio Diet app. The second round of HCP will be presented either the original version or if >30% rate the Portfolio Diet app poorly, the revised version of the Portfolio Diet app to review following the same assessment method with the addition of assessing the quality of the Portfolio Diet app using the MARS. The MARS is a widely used tool for assessing the quality of mobile health apps. It comprises a 19-item objective evaluation across four domains: engagement, functionality, aesthetics, and information. It 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.

Hypothesis:

Validating the HCP-facing toolkit will demonstrate support for HCP knowledge and use of the Portfolio Diet and Portfolio Diet mobile application in clinical practice. Demonstrating that HCP rate the Portfolio Diet app as usable, educational, high quality, and has potential use in practice will further support clinical translation of the Portfolio Diet. This toolkit will also be used in the CIHR-funded Coronary Heart Effectiveness Assessment of the Portfolio diet in primary care (CHEAP) trial.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 1A8
        • University of Toronto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HCP resource evaluation
HCP will be provided with resources to evaluate
Other: HCP-facing Portfolio Diet Infographic + Informative Video
Resources to evaluate include the healthcare professional-facing Portfolio Diet infographic (1-page) and 4-minute accompanying video
Other: Portfolio Diet Application
Resource to evaluate includes the Portfolio Diet mobile application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Face Validation
Time Frame: 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).
30 minutes
Content Validation
Time Frame: 30 minutes
Content validity will be determined if <30% of respondents rating questions in part A of the phase 1 questionnaire as irrelevant.
30 minutes
Knowledge Acquisition about the Portfolio Diet
Time Frame: 8 days
A composite of 4 multiple-choice questions will be used to assess knowledge acquisition.
8 days
Engagement with the Portfolio Diet App
Time Frame: 8 days
A composite of 11 open-ended and likert scale questions will be used to assess engagement with the app.
8 days
Acceptability of the Portfolio Diet App
Time Frame: 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.
8 days
Usability using the System Usability Scale
Time Frame: 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.
8 days
Usability using the mHealth App Usability Questionnaire
Time Frame: 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.
8 days
Quality using the Mobile Application Rating Scale
Time Frame: 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.
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Investigators

  • Principal Investigator: Laura Chiavaroli, PhD, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2023

Primary Completion (Actual)

August 12, 2024

Study Completion (Actual)

August 12, 2024

Study Registration Dates

First Submitted

June 9, 2023

First Submitted That Met QC Criteria

June 19, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Estimated)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCPTestPD2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To assess diversity and representation of marginalized groups serviced by our sample, we will include questions on whether HCP service these communities. We will also collect some information on the HCP to describe our sample, including age, sex, gender, ethnicity and type of HCP; however, we will use ranges or groupings of options as selections for responses to reduce identifiable information. No other personal information is collected. These data will be presented descriptively in the publication of results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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