Effectiveness of Mobile Augmented Reality (MAR) on Oral Healthcare Education for the Independent Elderly
1 other identifier
interventional
75
1 country
6
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2023
Shorter than P25 for not_applicable
6 active sites
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
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedFirst Posted
Study publicly available on registry
April 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2023
CompletedJuly 28, 2023
April 1, 2023
4 months
March 13, 2023
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
EXPERIMENTALThe participants in this group will attend the MAR oral health education program
lecture-based group
ACTIVE COMPARATORThe participants in this group will attend the lecture oral health education program
controlled group
NO INTERVENTIONThe 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
The oral health education program that will be delivered by traditional lecture-based process
Eligibility Criteria
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
Taoyuan Activity Center
Taipei, 112, Taiwan
Datong Activity Center
Taipei, Taiwan
Hushan Village Activity Center
Taipei, Taiwan
Quanyuan village activity center
Taipei, Taiwan
Zhongxin Village Activity Center
Taipei, Taiwan
Study Officials
- PRINCIPAL INVESTIGATOR
Ming-Lun Hsu
National Yang Ming Chiao Tung University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- 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