Digital Health Literacy on COVID-19 for All: Co-creation and Evaluation of Interventions for Ethnic Minorities and Chinese People With Chronic Illnesses in Hong Kong

August 21, 2023 updated by: Dr Angela Leung, The Hong Kong Polytechnic University
During the pandemic, people are anxious for information, and electronic platform serves the purpose of having first-hand health information and spreading it to massive population within a short time. However, the source and credibility of the influx of online information are hard to be verified. Digital health literacy (DHL) is the capacity to access, understand, evaluate, and apply health information from electronic sources, which is an important attribute that everyone should possess. Recent studies from our group in Hong Kong have shown that, during the COVID-19 pandemic, DHL is an issue facing people of all ages, especially ethnic minorities (EMs), people with chronic illnesses (PWCI), and professional and lay caregivers (CGs). Considering that, the present research project aims to co-create DHL interventions with these three groups of people to meet their specific needs in DHL, in addition, to assess the efficacy of the DHL interventions on eHealth literacy, vaccine literacy, and actions taken for COVID-19 prevention. The present research is a 4-year project, involving three phases. Phase 1 involves focus group interviews and cognitive interviews with the three groups of people for developing interventions and evaluating the proposed interventions. Phase 2 involves individual interviews with the three groups of people for testing the feasibility and acceptability of the interventions. Phase 3 involves a 6-month longitudinal quantitative research, testing for the efficacy of the interventions in three dimensions: literacy, attitude, and behavior. Participants from the three groups will be invited to join virtual or face-to-face training, watch short videos on social media, participate in virtual bi-weekly group discussion, and fill in questionnaires for five times during the course of the study. This co-creation of new knowledge by stakeholders and researchers is expected to increase the uptake of the research outcomes and adoption of the DHL interventions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
528

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • ethnic minorities (EMs), people with chronic illnesses (PWCI), and caregivers (CGs)
  • able to use a computer, smartphone, or laptop to access the Internet at home

Exclusion Criteria:

  • diagnosis of an acute psychotic disease or life-limiting condition; having a visual, auditory, or fine motor disorder.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Digital health literacy intervention
The interventions will be developed based on the Best Practices for Digital Health Literacy, WHO health literacy toolkits and the findings of the interviews. The content to be covered in the intervention will include news about vaccines; alerts about COVID-19 preventive measures; guidelines on social distancing, COVID-19 screening test arrangements, vaccination and compulsory quarantines; COVID-19-related law enforcement; and self-monitoring of COVID-19 symptoms
Behavioral: Digital health literacy intervention
Participants from the intervention group will be invited to join virtual or face-to-face training, watch short videos on social media, participate in virtual bi-weekly group discussion, and fill in questionnaires for five times during the course of the study
No Intervention: Control
No intervention will be provided to the control group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
eHealth Literacy Efficacy
Time Frame: baseline, 8-week post intervention, 4-week post follow-up, 8-week follow up, and 12 week follow up
Measured by the eHealth Literacy scale (eHEAL), an 8-item self-reported efficacy scale scored on a 5-point Likert scale
baseline, 8-week post intervention, 4-week post follow-up, 8-week follow up, and 12 week follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Digital Health Literacy
Time Frame: baseline, 8-week post intervention, 4-week post follow-up, 8-week follow up, and 12 week follow up
Measured by Digital Health Literacy Instrument
baseline, 8-week post intervention, 4-week post follow-up, 8-week follow up, and 12 week follow up
Vaccine literacy
Time Frame: baseline, 8-week post intervention, 4-week post follow-up, 8-week follow up, and 12 week follow up
knowledge about and intention to receive the COVID-19 vaccine
baseline, 8-week post intervention, 4-week post follow-up, 8-week follow up, and 12 week follow up
Knowledge, attitudes, and practices towards COVID-19
Time Frame: baseline, 8-week post intervention, 4-week post follow-up, 8-week follow up, and 12 week follow up
Assess knowledge, attitudes, and practices towards COVID-19
baseline, 8-week post intervention, 4-week post follow-up, 8-week follow up, and 12 week follow up

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSEARS20210902004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data can be obtained from principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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