Intentionality the Matrix of HealingNCT07265726
Oral Health Education for Older Adults: Intentionality in Action
A study testing Intentional Interview and Expressive Arts Activities in people with Intentionality the Matrix of Healing and Community, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
After obtaining approval from the Institutional Review Board (IRB), the clinical trial will be registered on a designated trial registration website. Participant recruitment will be conducted online. Read more about this study
- Who is it for?
- Ages 40 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Intentionality the Matrix of Healing, Community, Middle-aged and Older Adults
- What is being tested?
- Intentional Interview and Expressive Arts Activities
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Jul 2025to 29 May 2026
- 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 40 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals aged 40 years or older (Vlietstra et al., 2024).
- Ability to hear, speak, and read Chinese, with no communication barriers in Mandarin or Taiwanese.
Who cannot join
- Edentulous individuals who do not use dentures.
- Individuals with severe food allergies, renal failure, or dysphagia.
- Individuals diagnosed with terminal illness under palliative care, severe psychiatric disorders, or cognitive impairments.
- Individuals with serious medical conditions that prevent standing or performing oral self-care behaviors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Effectiveness of the Intentionality the Matrix of Healing in Enhancing Oral Health Education Outcomes for Community-dwelling Middle-aged and Older
After obtaining approval from the Institutional Review Board (IRB), the clinical trial will be registered on a designated trial registration website. Participant recruitment will be conducted online. For individuals who meet the inclusion criteria and express interest, the principal investigator will verbally explain the study protocol, go over the informed consent form, and answer any related questions. Potential participants who meet the inclusion criteria and are willing to participate will be given time to consider their involvement in the study.
Inclusion criteria for this study are:
Read more
- Adults aged 40 and older
- Ability to hear, speak, and read Chinese, and communicate fluently in Mandarin or Taiwanese.
Exclusion criteria include:
- Being completely edentulous and not using dentures;
- Having severe food allergies, renal failure, or dysphagia;
- Being diagnosed with terminal illness under palliative care, severe mental illness, or cognitive impairment;
- Having a serious health condition that prevents standing or performing oral self-care behaviors.
Upon receiving verbal agreement from potential participants, the study procedure and the contents of the consent form will be explained again. This is a parallel randomized experimental study, with an estimated sample of 90 middle-aged and older adults recruited from the community through online means. Participants will be randomly assigned to one of three groups:
- intentional interviews combined with expressive arts activities,
- expressive arts activities only, or
- control group.
All three groups will receive oral health education before the intervention and six weeks after the intervention. Questionnaire surveys will be conducted one week and one month post-education to collect data on sarcopenia risk, eating assessment, grit, oral health literacy, and oral self-care behaviors. Statistical analyses will be performed on the collected data.
Participants who fully understand the study and agree to participate will sign an informed consent form. Two copies of the consent form will be prepared-one will be kept by the principal investigator, and a photocopy will be given to the participant for personal recordkeeping. Participants retain the right to decline or withdraw from the study at any time, even after signing the consent form. Their withdrawal will not affect their future rights, benefits, or services, and any previously collected data will be deleted upon request.
- Conditions
- Intentionality the Matrix of Healing, Community, Middle-aged and Older Adults, Oral Health Education
- Being tested
- Intentional Interview, Expressive Arts Activities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intentional InterviewBehavioural
Participants in this arm will receive an intervention
Expressive Arts ActivitiesBehavioural
Participants in this arm will engage only in expressive arts activities over a 6-week period.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants in the control group will not receive any intentional interview or expressive arts activity during the 6-week intervention period. They will receive oral health education after the same time interval as the experimental arms, ensuring consistency in outcome measurement. |
| Expressive Arts Activities Only | Active comparator | Participants in this arm will engage only in expressive arts activities over a 6-week period. These activities are designed to foster creative engagement and emotional well-being. After the intervention, participants will receive the same oral health education provided to all groups. Receives: Behavioral: Intentional Interview |
| Intentional Interview + Expressive Arts Activities | Experimental | Participants in this arm will receive an intervention combining an intentional interview based on the Intentionality Matrix of Healing framework with expressive arts activities. The intentional interview is designed to guide participants in reflecting on personal health-related intentions, while the expressive arts component facilitates emotional expression and engagement. After the 6-week intervention, all participants will also receive standardized oral health education. Receives: Behavioral: Intentional Interview; Behavioral: Expressive Arts Activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
sarcopenia risk
This study adopted the SARC-F questionnaire proposed by the Asian Working Group for Sarcopenia (AWGS). The tool consists of five questions aimed at assessing muscle function, including grip strength, endurance, walking ability, ability to stand up from a chair, and fall history in the past six months (Ishida et al., 2020). The first four items are scored based on the responses: no difficulty (0 points), some difficulty (1 point), and a lot of difficulty (2 points). The fifth item, fall history, is scored as follows: 0 falls = 0 points, 1-3 falls = 1 point, and 4 or more falls = 2 points. The total score ranges from 0 to 10, with higher scores indicating a greater risk of sarcopenia. A SARC-F score of 4 or higher suggests a positive result for self-screening, indicating the need for further medical evaluation and appropriate diagnostic and treatment interventions.
The sensitivity, specificity, and positive/negative likelihood ratios of the SARC-F for predicting sarcopenia and its risk
Measured: baseline, one week after the intervention, and at a one-month follow-up
eating assessment
This study utilized the Eating Assessment Tool-10 (EAT-10), a dysphagia screening tool included in the adult oral health assessment form issued by the Department of Oral Health, Ministry of Health and Welfare. The version used is the Chinese translation by Huang (2023) of the original tool developed by Belafsky et al. (2008). The EAT-10 consists of 10 items that assess self-perceived difficulties related to swallowing, encompassing physical, psychological, and social aspects. Example items include: "Swallowing problems have caused me to lose weight" and "Swallowing interferes with my ability to go out for meals." The scale has demonstrated good reliability and validity, with a Cronbach's alpha coefficient of 0.92. The total score ranges from 0 to 40, with a score of ≥3 indicating the presence of swallowing difficulties. Higher scores reflect a greater risk of oral frailty.
Measured: baseline, one week after the intervention, and at a one-month follow-up
grit
This study adopted the Chinese version of the Grit Scale (Grit-10) developed by Duckworth et al. (2009). The scale consists of 10 items across two main factors: passion (reverse-scored items) and perseverance. Example items include: "I often set a goal but later choose to pursue a different one" (passion, reverse-scored) and "I finish whatever I begin" (perseverance). The scale uses a 5-point Likert rating system, ranging from 1 (not at all like me) to 5 (very much like me).
Scoring is as follows: each item has a maximum score of 5. Odd-numbered items are reverse scored, and even-numbered items are positively scored. The total score of the odd-numbered items divided by 5 gives the passion subscale score, while the total score of the even-numbered items divided by 5 gives the perseverance subscale score. The sum of all 10 items divided by 10 yields the overall grit score.
Lin (2019) applied this Chinese version to university students and reported a Cronbach's alpha of 0.84 for the ov
Measured: baseline, one week after the intervention, and at a one-month follow-up
oral health literacy
This study adopted the short-form Health Literacy Dental Scale (HeLD-14) developed by Jones et al. (2015), which has a Cronbach's alpha of 0.87. The scale was translated into Simplified Chinese by Liu et al. (2021) (Chinese version of HeLD, HeLD-C), showing a Cronbach's alpha of 0.92, and was later adapted into a Traditional Chinese version by Cheng (2023). The Traditional Chinese version includes 13 items across seven domains:
Receptivity (e.g., "I care about my dental or oral health needs"),
Understanding (e.g., "I can fill out dental-related forms"),
Support (e.g., "I can bring family members or friends to dental visits"),
Economic Barriers (e.g., "I can afford the cost of dental or oral health care"),
Utilization (e.g., "I know how to make a dental appointment"),
Communication (e.g., "I can obtain alternative oral health opinions from other dentists"), and
Access to Resources (e.g., "I can follow the dentist's instructions").
The scale uses a 5-point Likert rating system r
Measured: baseline, one week after the intervention, and at a one-month follow-up
oral self-care behaviors
This study adopted the Oral Self-Care Behavior Scale revised by Cheng (2023), originally developed by Ho, Rita Chang et al. (2019). The scale consists of 10 items; example statements include: "I brush my teeth at least twice a day" and "I always brush my teeth before going to bed at night." A 4-point Likert scale is used, ranging from 1 (not at all) to 4 (completely). The total score ranges from 10 to 40, with higher scores indicating better oral self-care behavior. The Cronbach's alpha ranges from 0.78 to 0.87 (Cheng, 2023), demonstrating good reliability.
Measured: baseline, one week after the intervention, and at a one-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start2 Jul 2025
- Primary completion17 Dec 2025
- Study completion29 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intentionality the Matrix of HealingStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265726
- Sponsor's protocol ID
- 25MMHIS120e
- Status last verified
- Dec 2025
- First submitted
- 13 Jun 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effectiveness of the Intentionality the Matrix of Healing in Enhancing Oral Health Education Outcomes for Community-dwelling Middle-aged and Older
- ClinicalTrials.gov ID
- NCT07265726
- Acronym / sponsor ID
- 25MMHIS120e
- Conditions
- Intentionality the Matrix of Healing, Community, Middle-aged and Older Adults, Oral Health Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 5 Dec 2025 (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.
After obtaining approval from the Institutional Review Board (IRB), the clinical trial will be registered on a designated trial registration website. Participant recruitment will be conducted online. For individuals who meet the inclusion criteria and express interest, the principal investigator will verbally explain the study protocol, go over the informed consent form, and answer any related questions. Potential participants who meet the inclusion criteria and are willing to participate will be given time to consider their involvement in the study.
Inclusion criteria for this study are:
- Adults aged 40 and older
- Ability to hear, speak, and read Chinese, and communicate fluently in Mandarin or Taiwanese.
Exclusion criteria include:
- Being completely edentulous and not using dentures;
- Having severe food allergies, renal failure, or dysphagia;
- Being diagnosed with terminal illness under palliative care, severe mental illness, or cognitive impairment;
- Having a serious health condition that prevents standing or performing oral self-care behaviors.
Upon receiving verbal agreement from potential participants, the study procedure and the contents of the consent form will be explained again. This is a parallel randomized experimental study, with an estimated sample of 90 middle-aged and older adults recruited from the community through online means. Participants will be randomly assigned to one of three groups:
- intentional interviews combined with expressive arts activities,
- expressive arts activities only, or
- control group.
All three groups will receive oral health education before the intervention and six weeks after the intervention. Questionnaire surveys will be conducted one week and one month post-education to collect data on sarcopenia risk, eating assessment, grit, oral health literacy, and oral self-care behaviors. Statistical analyses will be performed on the collected data.
Participants who fully understand the study and agree to participate will sign an informed consent form. Two copies of the consent form will be prepared-one will be kept by the principal investigator, and a photocopy will be given to the participant for personal recordkeeping. Participants retain the right to decline or withdraw from the study at any time, even after signing the consent form. Their withdrawal will not affect their future rights, benefits, or services, and any previously collected data will be deleted upon request.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants in the control group will not receive any intentional interview or expressive arts activity during the 6-week intervention period. They will receive oral health education after the same time interval as the experimental arms, ensuring consistency in outcome measurement. |
| Expressive Arts Activities Only | Active comparator | Behavioral: Intentional InterviewParticipants in this arm will engage only in expressive arts activities over a 6-week period. These activities are designed to foster creative engagement and emotional well-being. After the intervention, participants will receive the same oral health education provided to all groups. |
| Intentional Interview + Expressive Arts Activities | Experimental | Behavioral: Intentional Interview, Behavioral: Expressive Arts ActivitiesParticipants in this arm will receive an intervention combining an intentional interview based on the Intentionality Matrix of Healing framework with expressive arts activities. The intentional interview is designed to guide participants in reflecting on personal health-related intentions, while the expressive arts component facilitates emotional expression and engagement. After the 6-week intervention, all participants will also receive standardized oral health education. |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals aged 40 years or older (Vlietstra et al., 2024).
- Ability to hear, speak, and read Chinese, with no communication barriers in Mandarin or Taiwanese.
Key exclusion criteria (4 listed)
- Edentulous individuals who do not use dentures.
- Individuals with severe food allergies, renal failure, or dysphagia.
- Individuals diagnosed with terminal illness under palliative care, severe psychiatric disorders, or cognitive impairments.
- Individuals with serious medical conditions that prevent standing or performing oral self-care behaviors.
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 |
|---|---|---|
| Intentional InterviewParticipants in this arm will receive an intervention | Behavioural | Expressive Arts Activities Only, Intentional Interview + Expressive Arts Activities |
| Expressive Arts ActivitiesParticipants in this arm will engage only in expressive arts activities over a 6-week period. | Behavioural | Intentional Interview + Expressive Arts Activities |
Primary outcome
sarcopenia risk
Time frame: baseline, one week after the intervention, and at a one-month follow-up
This study adopted the SARC-F questionnaire proposed by the Asian Working Group for Sarcopenia (AWGS). The tool consists of five questions aimed at assessing muscle function, including grip strength, endurance, walking ability, ability to stand up from a chair, and fall history in the past six months (Ishida et al., 2020). The first four items are scored based on the responses: no difficulty (0 points), some difficulty (1 point), and a lot of difficulty (2 points). The fifth item, fall history, is scored as follows: 0 falls = 0 points, 1-3 falls = 1 point, and 4 or more falls = 2 points. The total score ranges from 0 to 10, with higher scores indicating a greater risk of sarcopenia. A SARC-F score of 4 or higher suggests a positive result for self-screening, indicating the need for further medical evaluation and appropriate diagnostic and treatment interventions. The sensitivity, specificity, and positive/negative likelihood ratios of the SARC-F for predicting sarcopenia and its risk
eating assessment
Time frame: baseline, one week after the intervention, and at a one-month follow-up
This study utilized the Eating Assessment Tool-10 (EAT-10), a dysphagia screening tool included in the adult oral health assessment form issued by the Department of Oral Health, Ministry of Health and Welfare. The version used is the Chinese translation by Huang (2023) of the original tool developed by Belafsky et al. (2008). The EAT-10 consists of 10 items that assess self-perceived difficulties related to swallowing, encompassing physical, psychological, and social aspects. Example items include: "Swallowing problems have caused me to lose weight" and "Swallowing interferes with my ability to go out for meals." The scale has demonstrated good reliability and validity, with a Cronbach's alpha coefficient of 0.92. The total score ranges from 0 to 40, with a score of ≥3 indicating the presence of swallowing difficulties. Higher scores reflect a greater risk of oral frailty.
grit
Time frame: baseline, one week after the intervention, and at a one-month follow-up
This study adopted the Chinese version of the Grit Scale (Grit-10) developed by Duckworth et al. (2009). The scale consists of 10 items across two main factors: passion (reverse-scored items) and perseverance. Example items include: "I often set a goal but later choose to pursue a different one" (passion, reverse-scored) and "I finish whatever I begin" (perseverance). The scale uses a 5-point Likert rating system, ranging from 1 (not at all like me) to 5 (very much like me). Scoring is as follows: each item has a maximum score of 5. Odd-numbered items are reverse scored, and even-numbered items are positively scored. The total score of the odd-numbered items divided by 5 gives the passion subscale score, while the total score of the even-numbered items divided by 5 gives the perseverance subscale score. The sum of all 10 items divided by 10 yields the overall grit score. Lin (2019) applied this Chinese version to university students and reported a Cronbach's alpha of 0.84 for the ov
oral health literacy
Time frame: baseline, one week after the intervention, and at a one-month follow-up
This study adopted the short-form Health Literacy Dental Scale (HeLD-14) developed by Jones et al. (2015), which has a Cronbach's alpha of 0.87. The scale was translated into Simplified Chinese by Liu et al. (2021) (Chinese version of HeLD, HeLD-C), showing a Cronbach's alpha of 0.92, and was later adapted into a Traditional Chinese version by Cheng (2023). The Traditional Chinese version includes 13 items across seven domains: Receptivity (e.g., "I care about my dental or oral health needs"), Understanding (e.g., "I can fill out dental-related forms"), Support (e.g., "I can bring family members or friends to dental visits"), Economic Barriers (e.g., "I can afford the cost of dental or oral health care"), Utilization (e.g., "I know how to make a dental appointment"), Communication (e.g., "I can obtain alternative oral health opinions from other dentists"), and Access to Resources (e.g., "I can follow the dentist's instructions"). The scale uses a 5-point Likert rating system r
oral self-care behaviors
Time frame: baseline, one week after the intervention, and at a one-month follow-up
This study adopted the Oral Self-Care Behavior Scale revised by Cheng (2023), originally developed by Ho, Rita Chang et al. (2019). The scale consists of 10 items; example statements include: "I brush my teeth at least twice a day" and "I always brush my teeth before going to bed at night." A 4-point Likert scale is used, ranging from 1 (not at all) to 4 (completely). The total score ranges from 10 to 40, with higher scores indicating better oral self-care behavior. The Cronbach's alpha ranges from 0.78 to 0.87 (Cheng, 2023), demonstrating good reliability.
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 22 Sep 2026.
- Individual participant dataSharing planned: Yes
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intentional Interview and Expressive Arts Activities in people with Intentionality the Matrix of Healing and Community, run by Mackay Memorial Hospital at 1 site 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 4 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 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
sarcopenia risk (time frame: baseline, one week after the intervention, and at a one-month follow-up). The study lists 5 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 22 Sep 2026.