NCT05834790

Brief Summary

The goal of this clinical trial is to learn the outcomes of Mobile Augmented Reality (MAR) for oral health education program in the independent elderly. The main question it aims to answer is:

  • Can MAR for oral health education program provide better outcomes comparing to lecture-based education program and no intervention group. The activity centers from the list will be randomly chosen and assigned to MAR, lecture, and no intervention groups.
  • Participants from activity centers that were assigned as MAR and lecture groups will attend one time education program. They have to finish questionnaires 3 times and receive 2 times oral examination.
  • Participants from activity centers that was assigned as no intervention group will not attend any education program. They have to finish questionnaires 2 times and receive 2 times oral examination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2023

Completed
Last Updated

July 28, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

March 13, 2023

Last Update Submit

July 27, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • Baseline oral healthcare-related knowledge

    Fifteen statements will be used to measure participants' knowledge. The possible answers include True, False, and Don't know. Correct answer scores 1, while incorrect answer and Don't know score 0. A higher score indicates a higher degree of oral healthcare-related knowledge with a possible score of 0-15

    This outcome will be measured before intervention for all groups

  • Change of the baseline oral healthcare-related knowledge immediately after intervention

    Fifteen statements will be used to measure participants' knowledge. The possible answers include True, False, and Don't know. Correct answer scores 1, while incorrect answer and Don't know score 0. A higher score indicates a higher degree of oral healthcare-related knowledge with a possible score of 0-15

    This outcome will be measured immediately after intervention for lecture and MAR groups

  • Change of the baseline oral healthcare-related knowledge 2 weeks after intervention

    Fifteen statements will be used to measure participants' knowledge. The possible answers include True, False, and Don't know. Correct answer scores 1, while incorrect answer and Don't know score 0. A higher score indicates a higher degree of oral healthcare-related knowledge with a possible score of 0-15

    This outcome will be measured 2 weeks after intervention for all groups

  • Baseline self-efficacy about oral healthcare tools suitability evaluation and usage

    Seven statements were used to evaluate participants' self-efficacy about oral healthcare tools' suitability evaluation and usage. Each item will be scored on a 5-point Likert-type scale ranging from 1, strongly disagree, to 5, strongly agree. A higher score indicates a higher degree of self-efficacy with a possible score of 7-35.

    This outcome will be measured before intervention for all groups

  • Change of the baseline self-efficacy about oral healthcare tools suitability evaluation and usage immediately after intervention

    Seven statements were used to evaluate participants' self-efficacy about oral healthcare tools' suitability evaluation and usage. Each item will be scored on a 5-point Likert-type scale ranging from 1, strongly disagree, to 5, strongly agree. A higher score indicates a higher degree of self-efficacy with a possible score of 7-35.

    This outcome will be measured immediately after intervention for lecture and MAR groups

  • Change of the baseline self-efficacy about oral healthcare tools suitability evaluation and usage 2 weeks after intervention

    Seven statements were used to evaluate participants' self-efficacy about oral healthcare tools' suitability evaluation and usage. Each item will be scored on a 5-point Likert-type scale ranging from 1, strongly disagree, to 5, strongly agree. A higher score indicates a higher degree of self-efficacy with a possible score of 7-35.

    This outcome will be measured before intervention for all groups

Secondary Outcomes (6)

  • Baseline tongue coating

    This outcome will be measured before intervention

  • Change of the baseline tongue coating

    This outcome will be measured 2 weeks after intervention

  • Baseline plaque index

    This outcome will be measured before intervention

  • Change of the baseline plaque index

    This outcome will be measured 2 weeks after intervention

  • Baseline gingival index

    This outcome will be measured before intervention

  • +1 more secondary outcomes

Other Outcomes (2)

  • Baseline Usability Scale

    This outcome will be measured MAR group immediately after intervention

  • Change of the baseline Usability Scale

    This outcome will be measured MAR group 2 weeks after intervention

Study Arms (3)

MAR group

EXPERIMENTAL

The participants in this group will attend the MAR oral health education program

Other: Mobile Augmented Reality (MAR) for oral health education program

lecture-based group

ACTIVE COMPARATOR

The participants in this group will attend the lecture oral health education program

Other: Lecture-based oral health education program

controlled group

NO INTERVENTION

The participants in this group will not attend any oral health education program

Interventions

MAR application named MAKAR will be available to download and use for smartphones and tablets. Participants will need to scan QR code to access the content of oral health education program

MAR group

The oral health education program that will be delivered by traditional lecture-based process

lecture-based group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • the elderly who are able to use a smartphone
  • the elderly who can read and understand traditional Chinese

You may not qualify if:

  • the elderly who has communication problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Guandu Elderly Activity Center

Taipei, 112, Taiwan

Location

Taoyuan Activity Center

Taipei, 112, Taiwan

Location

Datong Activity Center

Taipei, Taiwan

Location

Hushan Village Activity Center

Taipei, Taiwan

Location

Quanyuan village activity center

Taipei, Taiwan

Location

Zhongxin Village Activity Center

Taipei, Taiwan

Location

Study Officials

  • Ming-Lun Hsu

    National Yang Ming Chiao Tung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Three activity centers from the list will be randomly chosen and assigned to MAR, lecture, and no intervention groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2023

First Posted

April 28, 2023

Study Start

April 1, 2023

Primary Completion

July 27, 2023

Study Completion

July 27, 2023

Last Updated

July 28, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

investigators decided to not share IPD to other researchers

Locations