AgedNCT05834790
Effectiveness of Mobile Augmented Reality (MAR) on Oral Healthcare Education for the Independent Elderly
A study testing Mobile Augmented Reality (MAR) for oral health education program and Lecture-based oral health education program in people with Aged, run by National Yang Ming Chiao Tung University at 6 sites in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aged
- What is being tested?
- Mobile Augmented Reality (MAR) for oral health education program and Lecture-based oral health education program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 6 sitesTaiwan
- Study dates
- 1 Apr 2023to 27 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- the elderly who are able to use a smartphone
- the elderly who can read and understand traditional Chinese
Who cannot join
- the elderly who has communication problems
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Guandu Elderly Activity Center
Taipei, 112
Taoyuan Activity Center
Taipei, 112
Datong Activity Center
Taipei
Hushan Village Activity Center
Taipei
Quanyuan village activity center
Taipei
Zhongxin Village Activity Center
Taipei
About this study
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.
Read more
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.
Read the detailed description
Background/purpose: Aging is an inevitable global trend in this century. Elderly people are more susceptible to general health and oral health diseases which have negative impacts on their quality of life. Oral healthcare education could be the optimal measure to provide knowledge and develop self-care skills for elderly people to improve their oral health conditions. However, traditional passive lecture-based education programs might not be effective enough. There are many opportunities to improve the education program through digital technology. Mobile augmented reality (MAR) could be integrated into oral healthcare education to make education more effective. In this study, investigators would like to develop and evaluate the effectiveness of MAR-integrated oral healthcare education, as well as compare outcomes with traditional lecture-based education.
Materials and methods: Sixty independent elderly (age 65 or older) from six of Taipei city's local activity centers will be recruited. The participants will be required to be able to use smartphones in their daily life. The participants from one of the three activity centers will be randomly assigned to the MAR group (n=20), the other one activity centers will be assigned to the lecture group (n=20), and the rest will be assigned to the control group (n=20). The MAR group will be taught with MAR integrated education program, the lecture group will be taught with a traditional lecture-based program, while the control group will not undergo any education program. Outcome measurement will include oral healthcare knowledge, self-efficacy of oral healthcare, the usability of the MAR system, tongue coating, plaque index, and gingival index. The pre-, post-intervention, and two-weeks follow-up results will be compared by inferential statistics.
Results: The expected results are MAR integrated oral healthcare education could provide statistically significant improvement in participant outcomes compared to the control group and provide comparable or higher outcomes compared to the traditional education program. The usability score of MAR is acceptable.
Conclusion: MAR might be the feasible way to improve oral healthcare education for the independent elderly.
- Conditions
- Aged
- Being tested
- Mobile Augmented Reality (MAR) for oral health education program, Lecture-based oral health education program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Augmented Reality (MAR) for oral health education programOther
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
Lecture-based oral health education programOther
The oral health education program that will be delivered by traditional lecture-based process
| Study group | Role | What they receive |
|---|---|---|
| MAR group | Experimental | The participants in this group will attend the MAR oral health education program Receives: 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 Receives: Other: Lecture-based oral health education program |
| controlled group | No intervention | The participants in this group will not attend any oral health education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: This outcome will be measured before intervention for all groups
Secondary outcomes (6)
Baseline tongue coating
Tongue coating will be determined by the Winkel tongue coating index (WTCI) which divides the tongue into 6 sections in total. The score in each section could be 0-2. A score of 0 means no tongue coating, a score of 1 means a light coating, and a score of 3 means heavy coating. The higher score will show the heavier coating on the participant's tongue, ranging from 0-12.
Measured: This outcome will be measured before intervention
Change of the baseline tongue coating
Tongue coating will be determined by the Winkel tongue coating index (WTCI) which divides the tongue into 6 sections in total. The score in each section could be 0-2. A score of 0 means no tongue coating, a score of 1 means a light coating, and a score of 3 means heavy coating. The higher score will show the heavier coating on the participant's tongue, ranging from 0-12.
Measured: This outcome will be measured 2 weeks after intervention
Baseline plaque index
The plaque index in this study will be recorded by using the modified plaque score (MPS). This system combined the O'Leary plaque control record and the Silness and Löe plaque index. The MPS will be evaluated at 4 sites (mesiobuccal, mid-buccal, distobuccal, and lingual) of 6 teeth (maxillary right first molar, maxillary right central incisor, maxillary left second molar, mandibular right second molar, mandibular left central incisor, and mandibular left first molar). A score in each site could be 0-3. A score of 0 means no plaque, a score of 1 means a film of plaque adhering to the free gingival margin and adjacent area of the tooth, a score of 2 means moderate accumulation of soft deposit, and a score of 4 means abundance of soft matter. The total score will be interpreted as an MPS percentage. The higher percentage will show the heavier plaque deposited.
Measured: This outcome will be measured before intervention
Change of the baseline plaque index
The plaque index in this study will be recorded by using the modified plaque score (MPS). This system combined the O'Leary plaque control record and the Silness and Löe plaque index. The MPS will be evaluated at 4 sites (mesiobuccal, mid-buccal, distobuccal, and lingual) of 6 teeth (maxillary right first molar, maxillary right central incisor, maxillary left second molar, mandibular right second molar, mandibular left central incisor, and mandibular left first molar). A score in each site could be 0-3. A score of 0 means no plaque, a score of 1 means a film of plaque adhering to the free gingival margin and adjacent area of the tooth, a score of 2 means moderate accumulation of soft deposit, and a score of 4 means abundance of soft matter. The total score will be interpreted as an MPS percentage. The higher percentage will show the heavier plaque deposited.
Measured: This outcome will be measured 2 weeks after intervention
Baseline gingival index
The Löe-Silness gingival index will be used to record the gingival status in this study. This system will be evaluated on 6 teeth (maxillary right first molar, maxillary right lateral incisor, maxillary left first bicuspid, mandibular right first molar, mandibular left lateral incisor, and mandibular right first bicuspid). A score in each tooth could be 0-3. A score of 0 means absence of inflammation, a score of 1 means mild inflammation, a score of 2 means moderate inflammation, and a score of 3 means severe inflammation. The average score will be calculated. The higher score will show more severe gingival inflammation, ranging from 0-3.
Measured: This outcome will be measured before intervention
Change of the baseline gingival index
The Löe-Silness gingival index will be used to record the gingival status in this study. This system will be evaluated on 6 teeth (maxillary right first molar, maxillary right lateral incisor, maxillary left first bicuspid, mandibular right first molar, mandibular left lateral incisor, and mandibular right first bicuspid). A score in each tooth could be 0-3. A score of 0 means absence of inflammation, a score of 1 means mild inflammation, a score of 2 means moderate inflammation, and a score of 3 means severe inflammation. The average score will be calculated. The higher score will show more severe gingival inflammation, ranging from 0-3.
Measured: This outcome will be measured 2 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start1 Apr 2023
- Primary completion27 Jul 2023
- Study completion27 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgedStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three activity centers from the list will be randomly chosen and assigned to MAR, lecture, and no intervention groups.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-Lun Hsu, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834790
- Sponsor's protocol ID
- MAR2023
- Status last verified
- Apr 2023
- First submitted
- 13 Mar 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: investigators decided to not share IPD to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mobile Augmented Reality (MAR) on Oral Healthcare Education for the Independent Elderly
- ClinicalTrials.gov ID
- NCT05834790
- Acronym / sponsor ID
- MAR2023
- Conditions
- Aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background/purpose: Aging is an inevitable global trend in this century. Elderly people are more susceptible to general health and oral health diseases which have negative impacts on their quality of life. Oral healthcare education could be the optimal measure to provide knowledge and develop self-care skills for elderly people to improve their oral health conditions. However, traditional passive lecture-based education programs might not be effective enough. There are many opportunities to improve the education program through digital technology. Mobile augmented reality (MAR) could be integrated into oral healthcare education to make education more effective. In this study, investigators would like to develop and evaluate the effectiveness of MAR-integrated oral healthcare education, as well as compare outcomes with traditional lecture-based education.
Materials and methods: Sixty independent elderly (age 65 or older) from six of Taipei city's local activity centers will be recruited. The participants will be required to be able to use smartphones in their daily life. The participants from one of the three activity centers will be randomly assigned to the MAR group (n=20), the other one activity centers will be assigned to the lecture group (n=20), and the rest will be assigned to the control group (n=20). The MAR group will be taught with MAR integrated education program, the lecture group will be taught with a traditional lecture-based program, while the control group will not undergo any education program. Outcome measurement will include oral healthcare knowledge, self-efficacy of oral healthcare, the usability of the MAR system, tongue coating, plaque index, and gingival index. The pre-, post-intervention, and two-weeks follow-up results will be compared by inferential statistics.
Results: The expected results are MAR integrated oral healthcare education could provide statistically significant improvement in participant outcomes compared to the control group and provide comparable or higher outcomes compared to the traditional education program. The usability score of MAR is acceptable.
Conclusion: MAR might be the feasible way to improve oral healthcare education for the independent elderly.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three activity centers from the list will be randomly chosen and assigned to MAR, lecture, and no intervention groups.
| Arm | Type | Receives |
|---|---|---|
| MAR group | Experimental | Other: Mobile Augmented Reality (MAR) for oral health education programThe participants in this group will attend the MAR oral health education program |
| lecture-based group | Active comparator | Other: Lecture-based oral health education programThe participants in this group will attend the lecture oral health education program |
| controlled group | No intervention | –The participants in this group will not attend any oral health education program |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- the elderly who are able to use a smartphone
- the elderly who can read and understand traditional Chinese
Key exclusion criteria (1 listed)
- the elderly who has communication problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Augmented Reality (MAR) for oral health education programMAR 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 | Other | MAR group |
| Lecture-based oral health education programThe oral health education program that will be delivered by traditional lecture-based process | Other | lecture-based group |
Primary outcome
Baseline oral healthcare-related knowledge
Time frame: This outcome will be measured before intervention for all groups
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
Change of the baseline oral healthcare-related knowledge immediately after intervention
Time frame: This outcome will be measured immediately after intervention for lecture and MAR groups
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
Change of the baseline oral healthcare-related knowledge 2 weeks after intervention
Time frame: This outcome will be measured 2 weeks after intervention for all groups
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
Baseline self-efficacy about oral healthcare tools suitability evaluation and usage
Time frame: This outcome will be measured before intervention for all groups
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.
Change of the baseline self-efficacy about oral healthcare tools suitability evaluation and usage immediately after intervention
Time frame: This outcome will be measured immediately after intervention for lecture and MAR groups
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.
Change of the baseline self-efficacy about oral healthcare tools suitability evaluation and usage 2 weeks after intervention
Time frame: This outcome will be measured before intervention for all groups
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.
6 secondary outcomes
Baseline tongue coating
Time frame: This outcome will be measured before intervention
Change of the baseline tongue coating
Time frame: This outcome will be measured 2 weeks after intervention
Baseline plaque index
Time frame: This outcome will be measured before intervention
Change of the baseline plaque index
Time frame: This outcome will be measured 2 weeks after intervention
Baseline gingival index
Time frame: This outcome will be measured before intervention
Change of the baseline gingival index
Time frame: This outcome will be measured 2 weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Individual participant dataSharing planned: No. investigators decided to not share IPD to other researchers
Related trials for Aged
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Lun Hsu principal investigator
National Yang Ming Chiao Tung University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Augmented Reality (MAR) for oral health education program and Lecture-based oral health education program in people with Aged, run by National Yang Ming Chiao Tung University at 6 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline oral healthcare-related knowledge (time frame: This outcome will be measured before intervention for all groups). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.