VR/AR Educational Module on Oral Care Practices for Home Care Worker

October 2, 2023 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

The Effects of Virtual Reality and Augmented Reality (VR/AR) Educational Module on Oral Care Practices for Home Care Worker

This study is to evaluate the effect of the elderly oral care knowledge, attitude ,self-efficacy ,oral care behavior between the home care workers(HCW) in VR(Virtual reality)/AR(Augmented reality)group and control group after intervention. Home care workers will be randomly assigned to the VR/AR group and the control group. Home care workers in the VR/AR group will use VR to learned about the oral care methods and processes in the different case. AR allows HCWs to actually operate cleaning teeth. The home care workers in the control group used traditional teaching methods for oral care. Baseline and follow-up survey were used to collect the data in oral care knowledge, attitude ,self-efficacy ,oral care behavior.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

Detailed Description

A randomized experimental design was used. Home care workers (HCWs) in the VR/AR group received 2.5 hours of VR(Virtual reality) and AR(Augmented reality) training. VR offered learners the standard oral care procedures under different physical and oral health conditions in elderly people and AR simulation training for the manual Bass brushing technique. The home care workers in the control group used traditional teaching methods for oral care. A self-administered questionnaire was used to collect data regarding oral care-related knowledge, attitude, self-efficacy, intention to assist in oral care behavior and behavior before and after the intervention, 3-month follow-up and 6-month follow-up. All participants finished the self-administered questionnaire within 10-15 minutes and handed it to researchers at VR/AR oral care training center in Kaohsiung Medical University.Generalized estimating equations (GEEs) was used to analyze the differences between pre-test, post-test and follow-ups.

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 (Actual)

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.
173

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 Locations

  • Taiwan
    • Sanmin Dist
      • Kaohsiung city, Sanmin Dist, Taiwan, 80708
        • Kaohsiung Medical University

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • certificated home care workers in Taiwan.

Exclusion Criteria:

  • aged above 65 were excluded.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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: VR/AR group
Home care workers (HCW)HCWs in the VR/AR group received 2.5 hours of VR and AR training. VR offered learners the standard oral care procedures under different physical and oral health conditions in elderly people and AR simulation training for the manual Bass brushing technique.
Behavioral: VR and AR oral healthcare curriculum training
HCWs in the VR/AR group received 2.5 hours VR and AR oral healthcare curriculum training. VR oral care training system was training the standard oral healthcare procedure for different physical and oral conditions in elderly people.AR oral care training system was training for the manual Bass brushing technique.
Placebo Comparator: Control group
The home care workers in the control group received 2.5 hours of traditional teaching methods for oral care.
Behavioral: traditional teaching methods oral healthcare curriculum
HCWs in the control group received 2.5 hours traditional teaching methods of oral healthcare curriculum training.

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
oral care behavior
Time Frame: Change from 3-month follow-up to 6-month follow-up. After two groups HCWs received the intervention, 3 months and 6 months HCWs would received follow-up questionnaire to finish the measurement.
Eight statements were used to evaluate the behavior in assisting in oral care behavior Item including that" I take the initiative to assist the elderly to perform oral care ." All response was coded as zero (not) or one (yes).
Change from 3-month follow-up to 6-month follow-up. After two groups HCWs received the intervention, 3 months and 6 months HCWs would received follow-up questionnaire to finish the measurement.

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
Oral care-related knowledge
Time Frame: After randomization, HCWs would receive pre-test before intervention and post-test after intervention immediately. The follow-up questionnaire to measure at 3 months and 6 months after intervention.
Ten statements were used to assess oral care-related knowledge. Item including that" Fluoride toothpaste for adults should have a fluoride content above 1000 ppm." A score of 0 (incorrect) and 1 (correct) was used for each statement. The total score ranged was 0-10.
After randomization, HCWs would receive pre-test before intervention and post-test after intervention immediately. The follow-up questionnaire to measure at 3 months and 6 months after intervention.
Attitude toward oral care
Time Frame: After randomization, HCWs would receive pre-test before intervention and post-test after intervention immediately. The follow-up questionnaire to measure at 3 months and 6 months after intervention.
Seven statements were used to assessment the attitude toward oral care, including' oral cleansing is a part of elderly people daily body cleaning.' A score was used the Liker scale with rating from 1 (completely disagree) to 5 (completely agree) was used for each statement. The total score ranged was 7-35.
After randomization, HCWs would receive pre-test before intervention and post-test after intervention immediately. The follow-up questionnaire to measure at 3 months and 6 months after intervention.
Self-efficacy of oral care
Time Frame: After randomization, HCWs would receive pre-test before intervention and post-test after intervention immediately. The follow-up questionnaire to measure at 3 months and 6 months after intervention.
Nine statements were used to measures the self-efficacy to oral care , including 'I am confident in helping elderly people brush their teeth with the modified Bass brushing technique.' A score was used the Liker scale with rating from 1 (completely disagree) to 5 (completely agree) was used for each statement. The total score was 9-45.
After randomization, HCWs would receive pre-test before intervention and post-test after intervention immediately. The follow-up questionnaire to measure at 3 months and 6 months after intervention.
Intention to assist in oral care behavior
Time Frame: After randomization, HCWs would receive pre-test before intervention and post-test after intervention immediately.
Eight statements were used to evaluate the intention to assist in oral care behavior , including 'I will take the initiative to assist the elderly in using the modified Bass brushing technique to brush their teeth.' A score was used the Liker scale with rating from 1 (completely disagree) to 5 (completely agree) was used for each statement. The total score ranged was 8-40.
After randomization, HCWs would receive pre-test before intervention and post-test after intervention immediately.

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.
Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hsiao-Ling Huang, Kaohsiung Medical 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 (Actual)

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.
October 13, 2021

Primary Completion (Actual)

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 30, 2022

Study Completion (Actual)

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 30, 2022

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).
June 21, 2022

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.
June 25, 2022

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.
June 28, 2022

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.
October 4, 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.
October 2, 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.
June 1, 2022

More Information

Terms related to this study

Keywords

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.
  • KMUHIRB- F(I)-20200098

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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